Regulatory Affairs

Therapeutics have become increasingly complex and development timelines are often sharply compressed to meet urgent medical needs. BioTechLogic is highly experienced with the current requirements of the world’s leading regulatory bodies, allowing us to serve as a trusted guide on your journey to market.

Regulatory Filing Planning & Readiness

With comprehensive global regulatory and CMC strategies knowledge, we offer technical evaluations of regulatory submission source reports and commercialization and submission readiness gap assessments.

Filing Preparation, Review & Publishing

Preparation and/or review of regulatory documentation, including briefing packages, IND, BLA, NDA, IMPD, MAA, supplements/variations, or rest of world (ROW) filings. After an expert review of regulatory submissions before filing, we offer publishing support.

Regulatory Body Liaison

Regulators sometimes request information, or you may be managing an FDA-483 or other regulatory response–BioTechLogic offers full support.

Combination Product Filing

Combination products are subject to biopharmaceutical and medical device regulatory requirements, and we offer the expertise to manage these programs.

Internal & External Audits

Whether preparing for and supporting an external GMP audit by a global regulator (pre-approval inspection (PAI), pre-licensing inspection (PLI)) or planning and executing an internal audit, our team offers comprehensive capabilities.

Inspection Readiness


To ensure successful inspections, we conduct a risk evaluation well in advance of your inspection window. This assessment identifies high-risk areas in your supply chain, informing an inspection readiness plan and effective resource allocation.

Accelerated Filing Support

In addition to increased therapeutic complexity, leading regulatory bodies now offer many more options for accelerating drug products meeting critical unmet medical needs. BioTechLogic provides the expertise to navigate the multitude of approval options and manage drastically accelerated programs.

FDA
  • Orphan Drug Designation
  • Rare Pediatric Disease
  • Fast Track Designation
  • Breakthrough Therapy Designation
  • RMAT Designation
EMA
  • Accelerated Assessment
  • Conditional Marketing Authorization
  • Authorization Under Exceptional Circumstances
  • PRIME Designation
MHRA
  • Innovative Licensing and Access Pathway

Other Areas of Focus

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Regulatory Affairs

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