Regulatory

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.

BioTechLogic offers full support, whether in response to a request for information or in managing an FDA warning letter or other communication.

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.

BioTechLogic assists companies by supporting the registration of drug-device combination products. We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug (21 CFR 210/211), Biologics (21 CFR 600), Device (21 CFR 820) and Combination Products (21 CFR Part 4). BioTechLogic’s team can guide you through the matrix of requirements.

Regulatory Support for combination products includes the following:

• Generate and review the CMC sections of regulatory submissions that support combination products [e.g., 3.2.P.2.4, 3.2.P.3.3, 3.2.P.7, and 3.2.R.4: Medical Devices (Device Design Controls), etc.]

EU combination product support

• Prepare General Safety and Performance Requirements (GSPR) reports
• Obtain the opinion of a notified body

We support end-to-end traceability of analytical data from collection and analysis to data management for your quality system, regulatory filings, CMC submission summaries, and beyond. Additionally, we assist with SOP generation and management to ensure excellence in analytical execution.