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Regulatory Affairs

Comprehensive regulatory support across the entire product lifecycle. Our expertise covers all therapeutic areas and product types, on a global basis

Regulatory Affairs

Comprehensive regulatory support across the entire product lifecycle. Our expertise covers all therapeutic areas and product types, on a global basis

Experts in global Regulatory Affairs

G&L offers a full suite of services designed to support your product's journey from concept to market and beyond.

With decades of experience across over 100 global markets, our expertise spans the entire product lifecycle, ensuring that your products not only meet stringent regulatory requirements but also reach patients swiftly and safely.

Whether you are developing Small Molecules, Biologics, Vaccines, Gene and Cell Therapies, Antibody Drug Conjugates, Radioligand Therapies, other Advanced Therapeutic Medicinal Products (ATMPs), Medical Devices, or Consumer Healthcare products, G&L’s comprehensive regulatory services are tailored to help you achieve success at every stage.

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Pre-Approval

Our regulatory experts provide support to help you navigate your path from the early stages of drug development through to Agency approval.

G&L provides a full suite of Pre-Approval services, including regulatory strategy development, special designations and fast-track approval pathways, Health Authority interactions, clinical development plans, and IND/CTA authoring and submission.

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Authoring, Publishing and Submissions

G&L specializes in the technical authoring of global regulatory submissions and special designations, ensuring that your regulatory applications are comprehensive, high quality and best-placed for Agency approval.

With a wealth of technical experience you can trust, our teams work with you to ensure that your global submissions are authored, published and submitted worldwide, facilitating effective Agency review and timely regulatory approval.

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Post-Approval

Experts in Lifecycle Maintenance, G&L offers cost-effective outsourcing solutions to ensure your portfolios are maintained, enhanced and fully compliant.

With CMC and regulatory expertise spanning global markets and the full range of product modalities and therapeutic areas, we have a proven and demonstrable track record of delivering functional outsourcing of our clients’ mature product portfolios.

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Special Projects

With a wealth of experience in delivering large, global regulatory initiatives, we offer cost-effective solutions by strategically leveraging our global regulatory expertise and geographic footprint.

Whether an M&A Integration, Manufacturing Site Rationalization, Due Diligence, or Compliance review, G&L provides solutions that are optimized for success, enabling our clients to continue to focus on their “business as usual” activities.

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Experience you can trust

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Agency meetings

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CTA/IND filings

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MAA/NDA/BLA filings

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