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.
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.
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 IngredientOur expertise includes: