Registation

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Registration

DUNS number:getting Duns number, maintenance, updating address changes if any.

  • Establishing webtrader account
  • Drug establishment initial and annual registration,
  • Registering inporters
  • Obtaining FEI number
  • Obtaining Labelar code
  • Submitting NDC number
  • Self identification of facilities
  • Generating cover sheet for fee payment.
  • Food facility registration.
  • Blanket no change notification.
  • Registering with CVM for electronic submissions.
  • Establishing eSiubmitter toool for Vet submissions
  • 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.
  • 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).

Other Service