Registration of Pharmaceuticals

Registration of Pharmaceuticals / Vaccine and Medical Devices

The services in registration segments (both human and veterinary) are as follows:

Scientific advice to our customers to move in the right direction of registration since beginning of drug development and design
Conducting scientific advise meeting with health authorities to enable our partners / customers to meet regulatory expectations
GAP analysis of Marketing Authorization Application / Dossier and advising about preparation of right documents in line with Health Agency requirement.
Marketing Authorization Application / Dossier compilation and upload to health authority portal
Formulating response to questions / queries asked by health authorities till final approval
Renewal of registered product
Submitting annual reports on behalf of our customers
Submissions of variations for any proposed changes to the registered product
Other regulatory services requested by client such as 3P manufacturing and GMP audits

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