Regulatory Affairs Management

Ensuring Regulatory Compliance for New Product Submissions

Regulatory Affairs managers provide support for the lifecycle of drug, biologic, and combination products from pre-IND through licensure including the creation of and adherence to project timelines, monitoring of project resources, integration of multiple functional experts, management and attendance at FDA-Sponsor meetings, and experience with regulatory agency requirements, guidance, and preferences.

• INTERACT
• Pre-INDs
• INDs
• NDAs (including 505(b)(2)
• ANDAs
• BLAs (including 351(k)
• Orphan Drug Designations
• US Agent or Regulatory Contact
• Expedited Regulatory Pathways (BTD, FTD, RMAT, Accelerated Approval, Priority Review, etc.)

For decades, the Biologics Consulting Regulatory Affairs team has provided assistance navigating FDA interactions, managing projects from Pre-IND through approval into post-marketing activities, and keeping sponsors up to date on the latest regulatory   requirements to help them achieve success.

Our Regulatory Affairs Managers:

• Provide US Agent or Regulatory Contact support
• Provide Regulatory Project Management of multidisciplinary teams and regulatory oversight through all phases of development from Pre-IND into Post-Marketing activities
• Advise on current FDA regulations, guidance, and expectations based on regular interactions with the Agency
• Provide regulatory strategy and submission guidance on FDA requirements for meetings and applications
• Offer experience corresponding with FDA project managers and reviewers as the primary point of contact for Sponsors
• Share regulatory intelligence with sponsors by staying current on new regulations that may impact product development
• Offer Staff augmentation (short or long term partial or full time employee) to fill a Regulatory Affairs need or gap
• Collaborations with CROs and regulatory partnerships

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