Regulatory Affiars

Regulatory Affiars

Proper adherence to Regulatory Affairs Practice is one of the most crucial requirements in the pharmaceutical industry. For that, proper know-how about the regulatory framework is a must. Geekay Pharmagreen’s Regulatory Affairs Practices comprises of Mr. Girish Maheshwari’s technical cognizance and his in-depth understanding of this field.
We make sure that our clients’ regulatory affairs practice meets current standard under our guidance and that they are able to gather a basic understanding of it. Below, are the mentioned areas we impart our technical guidance of Regulatory Affairs;
– Registration of Drug Firms Establishments with US-FDA;
– Compiling and preparing required Dossier for the registration of Food and Dietary products, Medicinal Plant Products, Natural Products etc;
– Preparation of HACCAP Manual, Food Safety plan, Hazard identification ,analysis& erifications for food, dietary and herbal products & processes.
– Preparing Dossier and Submission in CTD in ECTD (Electronic Common Technical Document- registration of Drugs) and ACTD (Asian Common Technical Dossier). Format of NEES (Non-eCTD Electronic Submission) to semi-regulated and regulated market Health Authorities like Europe, US-FDA, UK-MHRA, MCC-SA, Indian DCGI and CDSO (ASEAN Markets), ROW markets, ANVISA, Health Canada etc.
– DMF (Drug Master File)/ CEP or COS (Certificate of Sustainability) /ASMF(Active Substance Master File)/ Technical Packages/ KDMF/ Technical Packages preparation,
– Submitting Site Master File as per the requirement of Local FDA requirement & PIC/s
– National Drug Code (NDC) and also Electronic Submission If you want your Pharma company to comply by the recent standards of Regulatory Affairs Practice then, look no further and make it a point to avail Geekay Pharmagreen’s guidance service in this area.