Biomylz’s regulatory department has a team of proactive professionals grouped from the desire of company to protect the consumer health, customer expectations by controlling safety and efficacy of the products in areas including Pharmaceutical, nutraceutical, food and related health segments. Biomylz’s regulatory affairs personals play a crucial in assuring that all Nutra, pharma, healthcare products are compliant with regulations governing the industry. They are the intermediate connection between the pharmaceutical Industries with the worldwide regulatory agencies. The Regulatory personals interact with various internal departments to function with high clarity to discuss on ever changing regulation, and to provide strategic, legal, scientific restraint & technical advice and evaluation of scientific data generated.

 

Drug / Active Substance Master Files (DMF/ASMF) & Dossiers:

                     R&D                              Manufacturing/Quality: DMF / ASMF                 Dossier / Tech Packs

Domain Activity:

  1. Product registration with International & Domestic DRAs, MOHs, DOHs, FDAs etc.
  2. Interaction with regulatory authority during onsite audits, certifications
  3. Preparation, Review and approval of ASMF, DMF, the technical packages, Dossiers.
  4. Technical training on current policies & guidelines to the required departments.