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Reading Scientific Services Ltd. (RSSL)

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Reading, GB

About Reading Scientific Services Ltd. (RSSL)

Reading Scientific Services Ltd is a global leader at the forefront of scientific analysis, consultancy, product development and training, serving the pharmaceutical, biopharmaceutical and medical device industries.

Pharmaceutical and Biopharmaceutical Services
• GMP QC Testing
• Raw Material, API and... Show more »

Reading Scientific Services Ltd is a global leader at the forefront of scientific analysis, consultancy, product development and training, serving the pharmaceutical, biopharmaceutical and medical device industries.

Pharmaceutical and Biopharmaceutical Services
• GMP QC Testing
• Raw Material, API and Finished Product Testing
• Biopharma Characterisation and Comparability
• Method Development, Validation or Transfer
• Pharmacopoeial testing (USP, EP JP etc)
• Biosimilar Testing
• Forced Degradation and Stability Testing
• Problem solving and contaminant identification
• Extractables and leachables
• Cleaning validation
• Physical and structural characterization
• Microbiological analysis
• Investigative and trouble shooting analysis
• Research and development (R&D) support
• Global analytical emergency response 24/7

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Certifications & Qualifications

FDA Inspected GMP ISO 17025

Our Services (100)


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Sterility Testing

Price on request

New Sterility Service.

Fast 16 day turnaround available and a fantastic first year offer.

Product Validations available now!

New Sterility Service.

Fast 16 day turnaround available and a fantastic first year offer.

Product Validations available now!

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Batch Release Testing

Price on request

We provide a comprehensive pharmaceutical and biopharma DS and DP release testing service to support you in ensuring the identity, purity, stability and quality of your products. Please contact us for details.

We provide a comprehensive pharmaceutical and biopharma DS and DP release testing service to support you in ensuring the identity, purity, stability and quality of your products. Please contact us for details.

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HPLC NMR USP EP BP JP Wet Chemistry Analysis Analytical GC Show 8 more tags Show less

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Analytical Chemistry Services

Price on request

RSSL’s Quality Control testing expertise, supporting the pharmaceutical and healthcare industries, provides a portfolio of chemical, physical and microbiological services.

RSSL can perform QC testing on raw materials, drug substances and drug products (including Schedule I-V controlled drugs) and can work with client projects... Show more »

RSSL’s Quality Control testing expertise, supporting the pharmaceutical and healthcare industries, provides a portfolio of chemical, physical and microbiological services.

RSSL can perform QC testing on raw materials, drug substances and drug products (including Schedule I-V controlled drugs) and can work with client projects within all phases of development through to marketed products.

We also work with clients to verify or transfer methods into our laboratories, ensuring a quick and easy route to QC release testing.

We run an efficient and effective GMP laboratory providing high quality results delivered to our client’s desired timelines. View our broad range of techniques below for both small molecule and biological applications.

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NMR Preparative HPLC LC-MS/MS GC-FID

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ICH Stability Testing

Price on request

The long term stability of drug products (and other healthcare related products) is key to its quality, efficacy, safety and commercialisation. The stability of a product can be assessed in many ways e.g. physical stability (e.g. tablet crumbling, precipitation, viscosity), chemical (e.g. API degradation) or... Show more »

The long term stability of drug products (and other healthcare related products) is key to its quality, efficacy, safety and commercialisation. The stability of a product can be assessed in many ways e.g. physical stability (e.g. tablet crumbling, precipitation, viscosity), chemical (e.g. API degradation) or microbiological.

It is therefore vital to carry out stability studies that conform to ICH requirements and that challenge your prototypes and products in a range of environments.

Stability Storage

Our pharmaceutical stability services include a range of monitored temperature, humidity, and light stability storage cabinets which comply with ICH Guidelines, covering requirements for climatic zones I to IV.

Our stability storage conditions:
-80°C and -20°C
5°C
25°C/60%RH
30°C/65%RH
30°C/75%RH and 40°C/75%RH

We can store Schedule I to V controlled drugs and low temperature storage is available. In addition, we are able to set up non-standard temperature/humidity conditions upon request.

Our storage facilities are secure, fully validated and maintained and are 21CFR compliant monitored 24 hours a day, with a dedicated out of hours response team on call in case of emergency.

Whether you require storage only, or in combination with in-house analytical testing, we can tailor our stability service to meet your needs.

Stability Testing

We have a vast range of analytical techniques under the general banners of chemical, microbiological and physical testing that can be used to assess the stability of your product and its packaging in accordance with GMP requirements. We have experience in the development of pharmaceutical stability indicating methods, including photostability and other stress conditions. From protocol preparation to the issue of final reports, we offer comprehensive project management, plus advice and support.

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Impurity Analysis

Price on request

Identification, isolation and purification of process related impurities can be critical to the development and manufacture of pharmaceutical products. Our technical specialist’s expertise in chromatographic and spectroscopic techniques can support with the isolation and identification of impurities from pharmaceutical products or... Show more »

Identification, isolation and purification of process related impurities can be critical to the development and manufacture of pharmaceutical products. Our technical specialist’s expertise in chromatographic and spectroscopic techniques can support with the isolation and identification of impurities from pharmaceutical products or active pharmaceutical ingredients (APIs).

Preparative scale isolation is carried out using techniques including but not limited to preparative liquid chromatography (HPLC and ÄKTA), freeze drying and solid phase extraction. Advanced spectroscopic techniques can then be used to identify the impurities of interest, these include nuclear magnetic resonance spectroscopy (NMR), mass spectrometry (MS) and Fourier transform infra-red spectroscopy (FTIR). Once the impurity has been identified, we can also offer further scale-up for the isolation of larger quantities of impurities for use as reference materials.

We are able to scale-up customer specific methods or develop reproducible extraction and purification methods for your products and API’s.

Services include:

  • Impurity isolation
  • Impurity characterisation
  • Sample purification
  • Method development
  • Method validation

Techniques available:

  • Low Pressure Liquid Chromatography with ÄKTApurifier
  • Preparative High Performance Liquid Chromatography (HPLC)
  • Chromatography Matrices - Reverse Phase, Ion Exchange and Normal Phase
  • Liquid Chromatography Mass Spectrometry (LC-MS)
  • Solid Phase Extraction (SPE)
  • Freeze Drying
  • Fourier Transform Infra-Red Spectroscopy (FTIR)
  • Nuclear Magnetic Resonance Spectroscopy (NMR)
  • Ultra-violet/Vis Spectroscopy (UV/Vis)
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Q Exactive Orbitrap LC-MS/MS system GC-MS HPLC NMR

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Protein Identification

Price on request

RSSL offers a rapid services to help you identify unknown proteins in you biopharma products.

RSSL offers a rapid services to help you identify unknown proteins in you biopharma products.

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Q Exactive Orbitrap LC-MS/MS system Oncology UPLC

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Microbiology Consulting

Price on request

RSSL offers a comprehensive consultancy service. This includes support for cleaning validation, and environmental monitoring. We offer training on how to perform swabbing and where and how to perform environmental monitoring. This is supported by complete pharmaceutical microbiology laboratory services.

RSSL offers a comprehensive consultancy service. This includes support for cleaning validation, and environmental monitoring. We offer training on how to perform swabbing and where and how to perform environmental monitoring. This is supported by complete pharmaceutical microbiology laboratory services.

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Cleaning Validation Enviromental Monitoring Consultancy

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Microbiology Testing

Price on request

We help you ensure the microbiological quality of your pharmaceutical, medical device and healthcare products, demonstrate that you are meeting regulatory requirements and prove that you have good hygienic production procedures.

You can rely on our MHRA-inspected microbiology laboratory to test your product’s microbiological... Show more »

We help you ensure the microbiological quality of your pharmaceutical, medical device and healthcare products, demonstrate that you are meeting regulatory requirements and prove that you have good hygienic production procedures.

You can rely on our MHRA-inspected microbiology laboratory to test your product’s microbiological quality and safety and provide method development and validation services. We also partner with you in instances where pharmaceutical microbiology testing, consultancy and troubleshooting are required, for continuous improvement of your processes and procedures or in response to a specific incident.

We perform microbial limits testing for specific pathogens, bacteria, yeast and moulds at all stages of the production cycle, from raw materials, finished products and medical devices.

In addition to this, we also offer preservative efficacy testing, kinetic turbidimetric LAL (Limulus Amebocyte Lysate) endotoxin analysis, analysis of water, challenge testing, and environmental monitoring to fully support in ensuring the microbiological quality and of your products.

Microbiological services include:

  • Microbial limits to EP, USP and JP
  • Quantitative endotoxin analysis
  • Preservative efficacy testing
  • Environmental monitoring
  • The European Suspension Test (eg EN1276, EN13697)
  • Water testing
  • Method development and validation

Typical product types tested:

  • Oral
  • Topical
  • Parenteral
  • Ophthalmic
  • Medical devices
  • Raw materials
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Microbial Limits (USP <61> <62>) EP Bacterial Endotoxin Testing Bioburden Test Method Validation TAMC TYMC Show 6 more tags Show less

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Extractable and Leachable Testing

Price on request

Extractable and leachable testing and analysis is critical in maintaining the quality of your drug product or combination drug delivery device. Let our expert analysis help you maximise the chance of a positive drug registration.

As part of your drug’s development and route to market, it is vital to identify both the substance... Show more »

Extractable and leachable testing and analysis is critical in maintaining the quality of your drug product or combination drug delivery device. Let our expert analysis help you maximise the chance of a positive drug registration.

As part of your drug’s development and route to market, it is vital to identify both the substance and source of any leachables as they may significantly alter the identity, strength or quality of the drug, risking patient safety.

There are a number of analyses which must be performed in order to comply with regulatory guidelines, and we can assist throughout with extractable and leachable testing. First, you need an extractables profile to be determined for all materials that will come into contact with your drug product. Once it has been determined whether any extractables in this profile are present as leachables within the product, you also need support in quantifying amounts and establishing the biological risk based on exposure.

We can provide analytical support during all stages of this process. We have performed controlled extractable and leachable testing and studies on a wide variety of containers, closures and medical combination drug delivery devices using state-of-the-art equipment, and our specialists’ expertise and experience means you can rely on us to successfully set up and manage your project.

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GC-MS LC-MS/MS ICP-MS

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Analytical Method Development

Price on request

Choose us as a partner for method development and validation, and you gain access to an experienced, specialist multi-disciplinary team. For both APIs and drug products, we have the capabilities to support you through the entire drug lifecycle.

Our cross-laboratory, multi-disciplinary approach, combined with exemplary customer... Show more »

Choose us as a partner for method development and validation, and you gain access to an experienced, specialist multi-disciplinary team. For both APIs and drug products, we have the capabilities to support you through the entire drug lifecycle.

Our cross-laboratory, multi-disciplinary approach, combined with exemplary customer focus and communication, makes us an ideal partner for method development and validation activities. You can trust us to manage projects effectively and achieve key milestones.

We understand that as companies focus on achieving ever shorter timescales of drug to market, a tailored and pragmatic approach is vital in both Active Pharmaceutical Ingredient (API), Drug Product (DP) and medical device method development and validation activities. Many years of experience working with a diverse client base and multitude of different dosage forms means we can guide and advise you on developing robust, fit-for purpose methods appropriate for the specific phase of the development life-cycle. Our specialists offer a wealth of knowledge and advice on areas ranging from sample preparation and extraction techniques to regulatory aspects.

Following successful method development, we can perform method validation in line with an approved protocol at a level that reflects the ICH requirements for the particular project type and stage of API/DP development.

Techniques available include:

  • UltraViolet-Visible (UV/VIS)
  • High-Performance Liquid Chromatography (HPLC) with UV. Diode Array (DAD), or Fluorescence Detection (FLD)
  • Gas Chromatography with Flame Ionisation Detection (GC-FID)
  • Gas Chromatography-Mass Spectrometry (GC-MS)
  • Ion Chromatography with Conductivity Detection (IC-CD)
  • High-Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD)
  • Liquid Chromatography-Mass Spectrometry (LC-MS)
  • Atomic Absorption Spectroscopy (AAS)
  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
  • Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES)
  • Laser Diffraction (Mastersizer 2000 and 3000)

Method parameters include (based on ICH guidelines):

  • Specificity
  • Limits of detection and quantification
  • Linearity
  • Accuracy
  • Precision
  • Solution stability
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HPLC NMR GC-FID

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Chemical Contaminant Analysis

Price on request

We specialise in resolving chemical contaminant issues for the pharmaceutical industry, using in-house specialist expertise combined with a range of analytical techniques and state-of-the-art GMP-qualified equipment.

Our expertise in contaminant identification is well known, with our team’s expert understanding of the variety... Show more »

We specialise in resolving chemical contaminant issues for the pharmaceutical industry, using in-house specialist expertise combined with a range of analytical techniques and state-of-the-art GMP-qualified equipment.

Our expertise in contaminant identification is well known, with our team’s expert understanding of the variety of sampling, extraction and analytical methods available enabling us to provide you with the most thorough and effective analysis possible, whatever the analyte. Our multi-disciplinary approach enables us to support you in incidents of accidental or deliberate contamination, counterfeit and adulteration, and manufacturing or processing failures.

We understand the business impact of chemical contamination, and the importance of a rapid response to ensure consumer safety and protect your brand. Work with us for analysis and investigative consultancy and you gain an expert partner in resolving contamination issues. As well as identifying the contaminant, we support you in finding the root cause (whether accidental or malicious), understanding the safety and quality implications of an incident, and taking appropriate corrective action. Our analytical techniques include ICP-MS analysis as well as other spectroscopy methods.

Pharmaceutical contamination is often an emergency situation, where speed in resolution is imperative. You may wish to consider membership of our 24/7 Emergency Response Service (ERS) for guaranteed technical support whenever you need it.

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Microscopes Hach HIAC SEM HPLC NMR GC X-Ray fluoresence Show 7 more tags Show less

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Shelf Life Testing

Price on request

We perform real-time stability and shelf-life testing of ingredients and finished products to support you with food product development, claims substantiation testing and troubleshooting.

Assessing stability over shelf-life is a crucial stage in new food product development and reformulation. You need to ensure that your... Show more »

We perform real-time stability and shelf-life testing of ingredients and finished products to support you with food product development, claims substantiation testing and troubleshooting.

Assessing stability over shelf-life is a crucial stage in new food product development and reformulation. You need to ensure that your product maintains its characteristic flavour, texture, structural and chemical features throughout the length of its stated shelf-life.

We provide stability and shelf-life testing for raw ingredients and finished food products under a range of conditions, ensuring that you have full understanding of product changes and behaviour over time. We measure changes over shelf life for components such as sweeteners, preservatives, colours, fats, oils, and vitamins, looking at texture, rheology and more. We can also support you with food analysis and testing (including fats and oils testing) to ensure any claim you make about your product can be substantiated over its entire shelf-life for food product development and reformation.

For fats and oils testing and for finished products containing them, we provide an accelerated oxidative stability testing service using Rancimat and Oxipres equipment. Accelerated testing allows you to narrow down potential formulations to the most promising for real-time testing, and to assess the impact of different processing conditions on stability. Your food product development timescale is therefore shortened with our lipid analysis and lipid testing capability, leaving a quicker route to market. Our NPD consultancy has the knowledge to support you with your new product development process.

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ICH Stability Method Validation Method Transfer In Use Stability

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Product Quality Control

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Product Testing Services

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Microbiology

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Chemistry and Materials

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Protein Characterization

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Protein Characterization Services

Protein Characterization Services

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Glycosylation Analysis

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Glycosylation Analysis Services

Glycosylation Analysis Services

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Microbiology Assays

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Educational Services

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Training and Teaching Services

Training and Teaching Services

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Professional Development Consulting

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Spectroscopy

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Spectroscopy Services

Spectroscopy Services

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Spectroscopy Consulting

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Chromatography

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Chromatography Services

Chromatography Services

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Separation/Purification Services

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Purification Services

Purification Services

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Chromatography Consulting

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Particle Size Distribution

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Wet Chemical Analysis

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Drug Formulation Evaluation

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Protein Services

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Protein Services

Protein Services

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Biochemistry & Molecular Biology

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Biochemistry & Molecular Biology Services

Biochemistry & Molecular Biology Services

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Glycosylation Analysis Consulting

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Assay Development

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pH Measurement

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Chemical Stability Testing

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Microscopy

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Microscopy Services

Microscopy Services

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Imaging & Spectroscopy

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Imaging & Spectroscopy Services

Imaging & Spectroscopy Services

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Microscopy Consulting

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Proteomics

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Proteomics Services

Proteomics Services

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Moisture Analysis

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Loss on Drying Testing

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Chemical Analysis

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Powder Characterization

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Sulfated Ash Test

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Microbial Identification and Strain Typing

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Business Operations and Logistics Support

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Business Operations and Logistics Support Services

Business Operations and Logistics Support Services

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Staffing Services

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Central Lab Services

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Microbiology Quality Control

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Granulation/Compaction/Agglomeration

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Regulatory Affairs Services

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Regulatory Affairs Services

Regulatory Affairs Services

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Auditing and Compliance Support

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Chemistry, Manufacturing and Controls (CMC)

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Analytical Method Validation

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Karl Fischer Titration

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Solubility and Dissolution Testing

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Residual Impurity Analysis

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Compendial Testing

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Drug-Excipient Compatibility Studies

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Melamine Testing

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Melting Point Determination

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Raw Material Testing

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Accelerated Stability Testing

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Excipients

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Residue On Ignition (ROI) Testing

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Assay Development Consulting

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Biopharmaceutical Consulting

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Drug Development

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Drug Development Services

Drug Development Services

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Drug Discovery & Development

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Drug Discovery & Development Services

Drug Discovery & Development Services

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Drug Product Characterization

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Laboratory Equipment and Facility Management Services

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Microbial Limit Testing

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Particulate Analysis

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Product Appearance Test

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Leak Testing

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Bioproduct Safety Testing

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USP Water Testing

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USP Testing

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USP Testing Services

USP Testing Services

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Quality Assurance

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Materials Science

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Material Testing Services

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Pharmaceutical Product Testing

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Endotoxin Testing

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Dose Delivery Testing

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Accelerated Aging

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Discrete Chemical Analysis

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Bioburden Testing

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Residual Solvent Analysis

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Unknown Material Identification

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Aerosol Testing

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Protein Sequencing

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Protein Sequencing Services

Protein Sequencing Services

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Protein Formulation

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Biopharmaceutical Development

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Calorimetry

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NMR

Nuclear magnetic resonance spectroscopy
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Hydrolyzed Amino Acid Analysis

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Electron Microscopy

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Protein Digestion

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Post-Translational Modification Analysis

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Mass Spectrometry

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Dale Hreczuk-Hirst

Business Development Manager

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