Regulatory Services
Regulatory consulting
Pharmaffiliates regulatory team is comprised of experts experienced in all regulatory issues. We focus on the clients needs and requirements, to provide services of high quality that meet their expectations.
- Flexibility
- Experience in multidisciplinary projects
- Excellent relations with Health Authorities
- Deep knowledge of legislation and regulatory environment
- Expertise in electronic submissions
Dossier preparation
Regulatory Authorities prescribe certain specific requirements in terms of the formats for submitting all the data generated during clinical studies as part of the dossier submission.
We prepare Dossiers and ANDA in Common Technical Data (CTD) format with a proactive thinking to avoid the deficiencies in the submission.
DMF and ANDA Submissions
Pharmaffiliates prepares appropriate Chemistry, Manufacturing and Control (CMC) regulatory document such as a Drug Master File (DMF) or Active Substance Master File (ASMF) which contains the relevant details of the manufacturing process for an Active Pharmaceutical Ingredient
Our expertise includes:- Our document enables competent authorities like FDA, EMA to review process information in support of third-party drug product marketing applications.
- We provide a letter of authorization/access that will allow the relevant authorities to review the DMF.
- We submit regulatory documents in the United States, Europe and across the world.
- We rely on decades of experience to power bioequivalence (BE) studies and minimize study failures.
- This competency in the clinical study design is invaluable for ANDAs that require clinical endpoint studies.
