REGULATORY AFFAIRS

As experts in FDA regulatory consulting, BCG will work with you to develop an appropriate and effective strategy to get your product to market. Our team will combine knowledge of your product with years of experience (including pre-clinical, clinical, CMC, drug safety, and pharmacokinetics) and literature research on your product and similar approvals. The final regulatory strategy for your product will balance risk, speed to approval, and cost to provide you with a description of the most appropriate regulatory path and explain why this path is the rational choice.

Regulatory Affairs Consulting: BCG provides Strategic Regulatory Affairs support, CMC Consulting, or regulatory submissions and correspondence, BCG has a strong Regulatory Affairs (RA) Department and consultants needed to support product development. Our regulatory consultants have expertise in oncology and many therapeutic areas.

Regulatory Submissions and Correspondence: Our Regulatory Affairs consultants and Medical Writing team have established good reputation in documents preparation. We can draft study-related documents of high quality, such as CSRs and CTDs. We can meet strict timelines by working collaboratively with >30 internal medical writers, using external resources when needed. Our RA experts can draft and support filings of marketing approval applications, followed by drafting their Q&As with competent authorities to obtain their approvals.