REGULATORY AFFAIRS

The Beloorbayir regulatory Department is a team of proactive professionals grouped from the desire of the company to protect consumer health and guarantee customer expectations by controlling safety and efficacy of products in areas including pharmaceutical, nutraceutical, food and related health products. Bayir regulatory affairs personnel play a crucial role in assuring all pharma, healthcare products are compliant with regulations governing the industry. They are the intermediate connection between their clients in the pharmaceutical Industry and the worldwide regulatory bodies. The regulatory personnel interact with various internal departments to function with high clarity in an ever changing regulatory environment, and to provide strategic, legal, scientific restraint & technical advise and evaluation of scientific data generated.

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, technical packages, Dossiers.
  4. Technical training provided to relevant departments as and when required or requested.