DMF Submissions | Dossier Submissions | DUNS Number| Establishment registration

Evaluation of process for any possible genotoxic impurities and setting limits for the same as per the applicable guidelines.Setting specification limit for impurities.Providing guidance through out life cycle of the product.Guiding on all regulatory issues faced during day to day activities (from customer or agency).CESP account establishment for EU filings Submitting DMF to US FDA, EU countries, Health Canada, TGA in eCTD format…. Converting existing paper copy dmf to eCTD Submitting VMF to USFDA in electronic format.Responding to the queries received from the agencies in a timely manner. Submitting CEP to EDQM.Responding to the queries received from EDQM and getting CEP approval in timely manner.

Leave a Reply

Your email address will not be published. Required fields are marked *