Regulatory Affairs and Product Safety

Harlan Laboratories is the leading provider of consulting services.  Our regulatory consultants and risk assessors are in extremely close contact with major authorities, keeping them current with the latest developments and regulatory requirements. Regulatory consultants and risk assessment experts work together to provide seamless development and execution of regulatory strategies. Our vast experience and in-depth knowledge ensures that your projects are dealt with by competent experts who advise on a cost effective way to rapidly bring your product to market.

Before the start of a non-clinical development program we can advise on:

• The procedures for marketing authorization in Europe (EMEA) and in the United States (FDA)
• Design of an appropriate regulatory strategy, depending upon
• Nature of the product (new chemical entity, biotechnological)
• Intended indications
• Possible different requirements of the various regulatory authorities for the product
• Existing marketing authorizations for comparable products (competitors)
• Design of an appropriate study program for the client, together with specialists in toxicology, analytics, pathology, pharmacokinetics and metabolism

Relations with the authorities

• Scientific advice for the suitability of special studies/alternatives in the program
• Special protocol assessment for dose selection (carcinogenicity studies, but also other studies)

Expert reports for various regulatory topics

• Literature search and compilation, critical evaluation (reports/recommendations)
• Risk assessments (including Environmental Risk Assessment Phase I)

Clinical trial applications

• Preparation of documents/briefing reports for pre-IND meetings and IND filings (FDA)
• Preparation of documents/briefing reports for ethics committees and national authorities (Europe)

Quality

• Preparation of Quality Overall Summaries (QOS)
• Compilation of Drug Master Files (DMF)
• Certificates of Suitability (CEP) Procedures (Compatibility with Ph. Eur.)

Safety

• Preparation of tabulated and written summaries
• Preparation of non-clinical overviews
• Expert reports for veterinary pharmaceuticals

Common Technical Document (CTD)

• Support of the client to find an experienced partner, supervision of the preparation/quality check of existing modules