Area Served

Regulatory Affairs

Our Regulatory Affairs consulting group is comprised of former senior-level managers, reviewers, and industry experts. Our goal is simple; provide simple, workable solutions for client's regulatory problems or issues at the highest levels of efficiency and excellence.

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Regulatory Affairs
Regulatory Affairs

Services and features include advising on a full range of regulatory compliance and scientific issues related to generics (including complex generics) and new drugs, as well as prepare and/or provide assistance in the preparation and electronic submission of all types of regulatory documents, including drug applications, e.g., ANDAs, NDAs (5050(b)(2) and 505 (b)(1)), DMFs (Type II, III, IV), and other FDA regulatory forms.

Leveraging vast knowledge and experience, MedReg Consultants assists clients in:
↪   DMF /Dossier Preparation
↪   Dossier Compilation and Submission
↪   DMF Compilation for Open and close parts
↪   CMC review of the technical documents
↪   Preparation of Pre-submission meeting package
↪   Develop regulatory strategy and project timeline