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Lambda Therapeutic Research Ltd.

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Ahmedabad, Gujarat, IN

About Lambda Therapeutic Research Ltd.

Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Toronto (Canada), Warsaw (Poland), London (UK) and USA.

Lambda is one of the most experienced Bioanalytical service providers in... Show more »

Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Toronto (Canada), Warsaw (Poland), London (UK) and USA.

Lambda is one of the most experienced Bioanalytical service providers in India. We provide services from two strategic locations in India and Canada. A highly qualified and experienced team of over 150 research professionals work round the clock and have helped accumulate an expansive assay catalogue of more than 850 validated methods.

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Our Services (32)


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eCTD Services

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Phase IV Clinical Trials

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  • Global presence with capabilities in Indian subcontinent, Europe and North America
  • Global team comprising of professionals equipped with full lifecycle Clinical Trial Management expertise
  • Huge investigator database for highly competitive recruitment potential in all therapeutic areas
  • Data submitted to all leading agencies including US FDA, EMEA, DCGI, ANVISA
  • Global presence with capabilities in Indian subcontinent, Europe and North America
  • Global team comprising of professionals equipped with full lifecycle Clinical Trial Management expertise
  • Huge investigator database for highly competitive recruitment potential in all therapeutic areas
  • Data submitted to all leading agencies including US FDA, EMEA, DCGI, ANVISA
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Phase III Clinical Trials

Price on request
  • Global presence with capabilities in Indian subcontinent, Europe and North America
  • Global team comprising of professionals equipped with full lifecycle Clinical Trial Management expertise
  • Huge investigator database for highly competitive recruitment potential in all therapeutic areas
  • Data submitted to all leading agencies including US FDA, EMEA, DCGI, ANVISA
  • Global presence with capabilities in Indian subcontinent, Europe and North America
  • Global team comprising of professionals equipped with full lifecycle Clinical Trial Management expertise
  • Huge investigator database for highly competitive recruitment potential in all therapeutic areas
  • Data submitted to all leading agencies including US FDA, EMEA, DCGI, ANVISA
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Phase II Clinical Trials

Price on request
  • Global presence with capabilities in Indian subcontinent, Europe and North America
  • Global team comprising of professionals equipped with full lifecycle Clinical Trial Management expertise
  • Huge investigator database for highly competitive recruitment potential in all therapeutic areas
  • Data submitted to all leading agencies including US FDA, EMEA, DCGI, ANVISA
  • Global presence with capabilities in Indian subcontinent, Europe and North America
  • Global team comprising of professionals equipped with full lifecycle Clinical Trial Management expertise
  • Huge investigator database for highly competitive recruitment potential in all therapeutic areas
  • Data submitted to all leading agencies including US FDA, EMEA, DCGI, ANVISA
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Pharmacovigilance and Post-Authorization Safety Studies (PASS)

Price on request

Lambda, as a Pharmacovigilance (PV) Partner, provides end-to-end pharmacovigilance and Materiovigilance (Pharmacovigilance for medical devices) services along with a flexible range of safety monitoring services to precisely compliment client’s needs.

Lambda is currently performing end-to-end pharmacovigilance for over 4000... Show more »

Lambda, as a Pharmacovigilance (PV) Partner, provides end-to-end pharmacovigilance and Materiovigilance (Pharmacovigilance for medical devices) services along with a flexible range of safety monitoring services to precisely compliment client’s needs.

Lambda is currently performing end-to-end pharmacovigilance for over 4000 authorisations globally, involving all therapeutic areas including oncology, anti retrovirals, biological and more. We also provide end to end vigilance services for Global clinical trials.

  • Promotes optimum patient safety, product stewardship and meets most comprehensive regulatory requirements
  • Robust and compliant Systems & Processes
  • Pharmacovigilance Safety Database – an E2B compliant advanced software solution that offers complex data analysis and querying of safety data sets, thus proactively meeting all risk management requirements
  • Regulatory Inspections – Over fifteen Pharmacovigilance regulatory inspections (including MHRA – United Kingdom, US FDA, AIFA – Italy, Polish MOH, FAAG-AFMPS – Belgium, CBG-MEB – Netherlands) have been conducted at Lambda over the last couple of years.
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Medical Imaging Services

Price on request
  • End-to-End Imaging Review Services for an extensive range of therapeutic categories
  • Cent-Re-View: fully validated & compliant Central Imaging Review Platform for performing central independent review in all therapeutic segments
  • Web-based Image upload from sites anywhere across the globe in compliance of HIPAA & local... Show more »
  • End-to-End Imaging Review Services for an extensive range of therapeutic categories
  • Cent-Re-View: fully validated & compliant Central Imaging Review Platform for performing central independent review in all therapeutic segments
  • Web-based Image upload from sites anywhere across the globe in compliance of HIPAA & local regulations
  • One of the quickest turnaround time in the industry for Application customization & real-time reviews
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Medical Writing

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MedSci vertical is a vital cog in the End to End Clinical Research Services from Lambda along with CTM, MA, PV, Biometrics and Bioanalytics.

Overview: End to End writing services including Publication Writing, Regulatory Writing, Safety Documents, and Medical Communications.

Deliverables

MedSci vertical is a vital cog in the End to End Clinical Research Services from Lambda along with CTM, MA, PV, Biometrics and Bioanalytics.

Overview: End to End writing services including Publication Writing, Regulatory Writing, Safety Documents, and Medical Communications.

Deliverables

  • Publications in peer-reviewed and indexed journals
  • Abstracts, posters (content and layout) and slidesets for congresses/conferences
  • Protocols including conceptualization, and clinical study reports
  • Summaries and eCTD modules
  • Investigators’ brochures
  • Aggregate reports (DSURs/PSURs/PBRERs/PADERs)
  • RMPs/REMs
  • Conference coverage and post-conference reports
  • Training modules
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Bioanalysis

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Chemistry and Materials

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Epidemiology, Healthcare, and Post-Authorization Studies

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Contract Services Directory

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Contract Research

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Phase I Clinical Trials

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  • Dedicated state-of-the-art Phase-I units in Ahmedabad,India & Toronto,Canada
  • Central cardiac monitoring system – cardiac Telemetry/Holters
  • Vast Experience of SAD/MAD,PK/PD and QTc Studies
  • Synergistic approach across geographies for timeline and cost advantages
  • Dedicated state-of-the-art Phase-I units in Ahmedabad,India & Toronto,Canada
  • Central cardiac monitoring system – cardiac Telemetry/Holters
  • Vast Experience of SAD/MAD,PK/PD and QTc Studies
  • Synergistic approach across geographies for timeline and cost advantages
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Biostatistical Analysis

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Biomarker Discovery

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Clinical Bioavailability/Bioequivalence Studies

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  • State-of-the-art facilities with global access to 640+ clinical beds inclusive of 36 specialized beds designed for specific studies
  • Excellent scientific expertise with capabilities of handling challenging studies
  • Robust recruitment & housing options customizable to sponsor / study requirements
  • Over 50 successful Inspections by leading regulatory agencies across all Lambda facilities
  • State-of-the-art facilities with global access to 640+ clinical beds inclusive of 36 specialized beds designed for specific studies
  • Excellent scientific expertise with capabilities of handling challenging studies
  • Robust recruitment & housing options customizable to sponsor / study requirements
  • Over 50 successful Inspections by leading regulatory agencies across all Lambda facilities
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Bioanalytical Assays

Price on request

Lambda is one of the most experienced Bioanalytical service providers in India. We provide services from two strategic locations in India and Canada. A highly qualified and experienced team of over 150 research professionals work round the clock and have helped accumulate an expansive assay catalogue of more than 850 validated... Show more »

Lambda is one of the most experienced Bioanalytical service providers in India. We provide services from two strategic locations in India and Canada. A highly qualified and experienced team of over 150 research professionals work round the clock and have helped accumulate an expansive assay catalogue of more than 850 validated methods.

Our GLP certified labs. are equipped with cutting edge, highly sophisticated instruments such as LC-MS/MS (40+ machines).

With over 850 validated methods and more than 10 methods at various stages of development at any given point of time, Lambda is perfectly geared up to handle your bio-analytical requirements. Lambda’s bio-analytical experts are capable of developing and validating new methods in a time span of approximately 06-08 weeks. We have experience in undertaking bioanalysis for pre-clinical / Toxicity studies and have developed methods for cocktail assays. The average reanalysis required is in less than 5% of the total samples. We are proud to state that a large part of our scientists of this team have been associated with us for over 8 years and come with a wealth of experience that enables us to successfully develop and validate even the most challenging of methods. Lambda has sensitive methods available with an LLOQ as low as 0.5 pg/mL. We have developed sensitive methods for NCEs in different species like Rat, Mice, Dog and Monkey using low sample volume.

Samples are stored in controlled and monitored low temperature storage ranging from -22±5°C, -65±10°C. Lambda’s freezers have a capacity to store 3 million samples.

Our vast expertise and in-depth understanding of stringent regulatory requirements ensure each project is accomplished in rapid turn-around times. We are proud to be a partner for several prominent generic pharma companies and have helped contribute to their aggressive First To File projects timelines by speedy bioanalysis in line with their requirements.

We have also successfully cleared 50+ Global regulatory inspections from FDA, EU, MHRA, ANVISA, ANSM, to name a few. Our Method Validation SOPs are in compliance with all major regulatory requirements. We have Global SOPs in place for all major bioanalytical processes.

The BA teams in India and Canada have robust knowledge sharing transfer procedures in place to assist any location in coming up to speed whenever a method transfer is needed from one location to the other on an urgent basis.

Our Bioanalytical forte can be summarized as:

  • Pre clinical assay capabilities
  • 850+ validated methods
  • High sensitivity instruments (API 6500 / XEVO TQS)
  • GLP certified Bioanalytical labs
  • Capabilities of analyzing 75,000+ samples per month on 40+ LC-MS/MS

Our BA scientists regularly attend several major bioanalytical forums held during the year to keep themselves abreast with the latest in this field. Lambda is a member of the Global CRO Council (GCC). Market Intelligence by Lambda’s inhouse Market Intelligence team of experts develop trend projections for First to File molecules and molecules going off patent that assist the BA team in proactively developing several methods to service the needs of the market. The team regularly contributes to posters presented at scientific conferences and pens various blogs that are available on the Lambda website as well.

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Bioanalytical Analysis LC/MS/MS

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Analytical Method Validation

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Analytical Method Development

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Analytical Chemistry Services

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Project Management

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Biomarkers

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Editorial and Writing Services

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Biostatistics & Bioinformatics

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Computational Modeling

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Marketing, Communication & Graphic Design Services

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Clinical Trials, Consulting, and Management

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Clinical Research

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Pharmacology & Toxicology

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Regulatory Affairs Services

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Regulatory Affairs Services

Regulatory Affairs Services

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Clinical Laboratory Services

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Clinical Laboratory Services

Clinical Laboratory Services

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Dr. Mrinal Kammili

Global Head - Business Development

Lambda Therapeutic Research Ltd. has not received any reviews.

Lambda Therapeutic Research Ltd. has not received any endorsements.