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).