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G&L Scientific

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Millburn, New Jersey, US

About G&L Scientific

G&L Scientific provides consulting, staff augmentation, outsourcing and support services for Clinical Research, Quality Assurance and Regulatory Affairs. With our own teams of experts based in our offices across Europe, Asia-Pacific and the US, as well as a pool of 2,500 consultants in over 100 countries,... Show more »

G&L Scientific provides consulting, staff augmentation, outsourcing and support services for Clinical Research, Quality Assurance and Regulatory Affairs. With our own teams of experts based in our offices across Europe, Asia-Pacific and the US, as well as a pool of 2,500 consultants in over 100 countries, we can find the right professional, at the right level, in the right location to fulfill your staffing needs.

Building a cohesive team that can meet aggressive deadlines is a daily challenge in the industry. With our highly experienced, multi-disciplinary background, we ensure your team is always at full strength and operating at maximum capacity. All our consultants are experienced in the use of multiple systems to speed up the onboarding process. Hand-picked by our in-house experts with your specific project in mind, they are continually overseen by us to ensure they’re exceeding your expectations.

Whether you need an individual or full project team, onsite or remote, G&L will design a custom solution that delivers significant savings to your resource budget, and allows you to flex your headcount in line with operational demands.

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Diversity Certificates

Small business

Our Services (43)


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Cold Chain Logistics

Price on request
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Quality Assurance

Price on request

• Audits of Trial Master Files, Clinical/Investigator Sites, CROs
• Establishment of quality system relating to Clinical Operations / Clinical Quality Assurance
• On-site/remote QA services
• Review of protocols, informed consent forms, investigator brochure, clinical study reports
• Release of investigational product for clinical... Show more »

• Audits of Trial Master Files, Clinical/Investigator Sites, CROs
• Establishment of quality system relating to Clinical Operations / Clinical Quality Assurance
• On-site/remote QA services
• Review of protocols, informed consent forms, investigator brochure, clinical study reports
• Release of investigational product for clinical studies
• Monitoring of clinical study sites
• GCP training
• Preparation/assistance with regulatory authorities’ inspections

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Regulatory Writing

Price on request

Our native English writers and local language writers are experienced across a wide range of medical and scientific subjects, multiple therapy areas and product types
Clinical Documents: Investigator Brochures, Protocols/ICs, Clinical Study Reports, Clinical Expert Reports
All Modules of the Application Dossier: Administrative,... Show more »

Our native English writers and local language writers are experienced across a wide range of medical and scientific subjects, multiple therapy areas and product types
Clinical Documents: Investigator Brochures, Protocols/ICs, Clinical Study Reports, Clinical Expert Reports
All Modules of the Application Dossier: Administrative, Quality, Non-Clinical, Clinical
Journals
Manuscripts
Conferences
Abstracts

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CMC Regulatory Compliance Support

Price on request

The pressure on businesses to ensure CMC Regulatory Compliance has never been higher, in terms of potential penalties, litigation and impact on brand perception.
G&L supports compliance efforts by:
– Reviewing your License against manufacturing processes and practices
– Conducting Gap Analyses to highlight non-compliance... Show more »

The pressure on businesses to ensure CMC Regulatory Compliance has never been higher, in terms of potential penalties, litigation and impact on brand perception.
G&L supports compliance efforts by:
– Reviewing your License against manufacturing processes and practices
– Conducting Gap Analyses to highlight non-compliance issues
– Putting a Remediation Plan in place
– Preparing Variations and submitting to relevant Agency

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Regulatory Affairs Consulting

Price on request

Access to current, validated and first-hand Regulatory Intelligence has never been so important, in order to successfully navigate approval pathways in new markets.

  • Current, validated and relevant Regulatory Intelligence to register products in new markets
  • Local knowledge from experts working in the field
  • Our Global... Show more »

Access to current, validated and first-hand Regulatory Intelligence has never been so important, in order to successfully navigate approval pathways in new markets.

  • Current, validated and relevant Regulatory Intelligence to register products in new markets
  • Local knowledge from experts working in the field
  • Our Global Scientific Partner Network saves you time, money and stress:
    • Provision of critical, tailored Regulatory Intelligence
    • Right-first-time submissions
    • Faster approvals

Regulatory Outsourcing

Over the past 10 years, Outsourcing has become a hot topic within Regulatory Affairs: everyone is doing it. But is it right for your business, and what should you outsource?
G&L will give you the very best advice by:
– listening to what you say, to gain a deep understanding of your business
– strategizing on how to achieve your goals through working with external agencies
– working in genuine partnership with you for as long as you need us

Regulatory Strategy

The effective application of scientific, product-specific and local knowledge is at the foundation of a successfully-executed Regulatory Strategy.
Regulatory Strategy specific to product type and approval market
Our experts will work closely with you to understand and achieve your goals:

  • Solid, well-planned strategic roadmap for product registration, minimizing delays in approval
  • Deep expertise in all phases of drug lifecycle, including pre-clinical, clinical, CMC and post-approval
  • In-country consultants in over 100 markets, best placed to advise on regional/national regulations and local hurdles
  • Detailed post-approval advice on requirements to maintain your license
  • Regulatory Strategy specific to product type and approval market

Strategic Outsourcing & Development Offering

Scalable, dedicated teams focused on creating long-term partnerships with Clients
– All levels of experience with specific skill set
– Efficient
– Cost-effective
– Measurable results

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Regulatory Document Preparation and Submission

Price on request

Carefully-considered, well-written and comprehensive submission packages are a central factor in achieving regulatory approvals in a timely manner

  • Familiarity with the regulations and timelines of different Health Agencies around the world, for successful submission and speedy approval
  • All product types covered, including... Show more »

Carefully-considered, well-written and comprehensive submission packages are a central factor in achieving regulatory approvals in a timely manner

  • Familiarity with the regulations and timelines of different Health Agencies around the world, for successful submission and speedy approval
  • All product types covered, including Biotechnology, Pharmaceuticals, Medical Devices, Consumer Healthcare and Generics
  • Assurance that your dossier contains the correct technical data for approval (Administrative, Quality, Non-Clinical and Clinical)
  • Submission of application and liaison with the Agency
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Regulatory Affairs Services

Price on request

License Management

The License Holder is legally responsible for making sure their License is properly maintained, and the product is strictly manufactured to approved terms
G&L has extensive experience in conducting License Maintenance activities across the world, with many different Health Agencies and all product... Show more »

License Management

The License Holder is legally responsible for making sure their License is properly maintained, and the product is strictly manufactured to approved terms
G&L has extensive experience in conducting License Maintenance activities across the world, with many different Health Agencies and all product types:
– Putting License Maintenance processes in place before Marketing Authorization is granted to minimize risk of future compliance issues
– Post-approval activities, including preparation and submission of Variations, Renewals, Line Extensions and Safety Updates

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Clinical Trial Management

Price on request

G&L Clinical Project Management Offering:
Quality deliverables on time and on budget
Our Project Managers’ experience includes:
– Study planning through to study completion
– Managing teams, study processes and other study-related 3rd parties

G&L Clinical Project Management Offering:
Quality deliverables on time and on budget
Our Project Managers’ experience includes:
– Study planning through to study completion
– Managing teams, study processes and other study-related 3rd parties

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Clinical Trial Monitoring

Price on request
  • Our Monitors are experienced across all geographical regions and all study phases, including varying levels of complexity
  • We ensure the study is completed according to the approved protocol, ICH/GCP guidelines and any local regulatory requirements
  • Our Monitors are experienced across all geographical regions and all study phases, including varying levels of complexity
  • We ensure the study is completed according to the approved protocol, ICH/GCP guidelines and any local regulatory requirements
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Clinical Data Management

Price on request
  • Consultants with experience and in-depth therapeutic knowledge across all study phases
  • End-to-end statistical analysis including clinical study design through to reporting of results
  • Consultants with experience and in-depth therapeutic knowledge across all study phases
  • End-to-end statistical analysis including clinical study design through to reporting of results
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Clinical Supply Chain Management and Logistics

Price on request
  • Our staff plan, forecast and manage supply of Study Drug through all phases of the study
  • We ensure Study Drug is at the right place, at the right time
  • Familiar with local regulations and timelines for export/import of Study Drug
  • Our staff plan, forecast and manage supply of Study Drug through all phases of the study
  • We ensure Study Drug is at the right place, at the right time
  • Familiar with local regulations and timelines for export/import of Study Drug
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Clinical Trial Design and Consulting

Price on request

Our early and late phase Clinical Scientists are medically and/or Ph.D qualified. They provide:
– Scientific consultancy for individual protocols or complete clinical development programs

Our early and late phase Clinical Scientists are medically and/or Ph.D qualified. They provide:
– Scientific consultancy for individual protocols or complete clinical development programs

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Statistical Analysis

Price on request
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Medical Writing

Price on request

Clinical Medical Writing

Experience across all kinds of medical writing and therapy areas: Manuscripts, Clinical Documents, Investigator Brochures, Journals

Native English writers
Local language writers

Clinical Medical Writing

Experience across all kinds of medical writing and therapy areas: Manuscripts, Clinical Documents, Investigator Brochures, Journals

Native English writers
Local language writers

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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
Price on request
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Clinical Drug Management

Price on request
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Clinical Data Collection, Analysis and Management

Price on request
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Editorial and Writing Services

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Project Management

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Data Services

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Scientific Sourcing

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Document Translation

Price on request
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Assay Development

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Business Development, Marketing & Operations

Price on request

Business Development, Marketing & Operations Services

Business Development, Marketing & Operations Services

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Literature Review/Curation

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Scientific Manuscript Editing

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Product Development, Testing, and Packaging

Price on request

Product Development, Testing, and Packaging Services

Product Development, Testing, and Packaging Services

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Technical Writing

Price on request
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Product Quality Control

Price on request

Product Quality Control Services

Product Quality Control Services

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Phase I Clinical Trials

Price on request
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Phase II Clinical Trials

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Phase III Clinical Trials

Price on request
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Phase IV Clinical Trials

Price on request
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CLIA Compliance Auditing

Clinical Laboratory Improvement Amendments compliant
Price on request
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Animal Models and Studies

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Clinical Trial Management Systems (CTMS)

Price on request
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Clinical Trial Documentation Support

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Grant Writing

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Clinical Trials, Consulting, and Management

Price on request
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Computational Modeling

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Business Operations and Logistics Support

Price on request

Business Operations and Logistics Support Services

Business Operations and Logistics Support Services

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Clinical Research

Price on request
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Marketing, Communication & Graphic Design Services

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G&L Capabilities Dec 2017.pdf

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G&L Device.PDF

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GL Scientific Overview 2017_.pdf

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