Regulatory Affairs

G&L Global Regulatory Intelligence Offering:

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

G&L Regulatory Strategy Offering:

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

G&L Dossier Preparation & Submission Offering:

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

G&L Medical Writing Offering:

• 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

G&L License Maintenance Offering:

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

G&L Compliance Reviews & Remediation Offering:

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

G&L Outsourcing Offering:

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