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.
With comprehensive global regulatory and CMC strategies knowledge, we offer technical evaluations of regulatory submission source reports and commercialization and submission readiness gap assessments.
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.
Regulators sometimes request information, or you may be managing an FDA-483 or other regulatory response–BioTechLogic offers full support.
Combination products are subject to biopharmaceutical and medical device regulatory requirements, and we offer the expertise to manage these programs.
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.
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.
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.