Regulatory Affairs

APS Regulatory Affairs team is comprised of highly experienced industry experts and former senior-level FDA and Health Canada managers and reviewers. The Regulatory Affairs team brings simple and workable solutions by producing high-quality documents quickly and efficiently. Our experts are well versed in all aspects of eCTD and dossier preparation whether it is for prescription (branded/generic, new chemical entities, novel formulations/administrations), OTC, herbal/nutraceutical products or medical device. We are experienced in preparing and leading regulatory agencies key meetings such as PIND, EOP2, and PNDA and preparing appropriate communications to answer agency inquiries.

Below is a list of additional solutions that we offer:

  • - Expert Regulatory CMC Compliance

  • - Preparation/Review of CMC Sections

  • - Regulatory Strategic Consulting for Product Lifecycle Management

  • - Regulatory Dossier Preparation for IND, CTA, BLA, NDA

  • - Pre-IND, Pre-NDA, and EOP2 Briefing Documents

  • - Preparation and Submission of IND, NDA, ANDA, PMA, BLA, 510(k), 505(b)(2), CTD/eCTD and DMF

  • - Annual Product Reviews (APRs)

  • - Drug Master File (DMF) and Veterinary Master File (VMF) preparation and review

  • - Preparing for, and Responding to, a Regulatory Inspection, (FDA, EU, MHRA, TGA and Health Canada)

  • - Regulatory Training

  • - Facilitating the Timely Approval of ANDAs and NDAs, including First-time Generic Approvals

  • - Preparing FDA Meeting Requests and Requisite Briefing Packages for PDUFA Meetings

  • - Evaluating and Providing Regulatory Guidance on Marketing of Unapproved Drug Products

  • - Facilitating the Resolution of Drug Listing Issues and Related U.S. Customs’ Detention Orders

  • - Integration of CMC, Pre-clinical and Clinical Documentation

  • - Long-term Regulatory Strategy Development and Support

  • - Comprehensive Regulatory Consulting for any Company Size, Molecule Type, or Stage of Development

  • - Review of Module 3 – Quality

  • - Preparation of Sub-module 2.3 – Quality Overall Summary

  • - Elaboration and/or Review of Technical Documents

  • - Elaboration and/or Review of Label and Instructions of Use

  • - Compliance with the Applicable Norms and Guidelines