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AKIS Pharma & Consultancy
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Biologicals

Pathways for vaccines, blood products, sera and other biologicals.

Services for biologicals

Select a service to send an enquiry.

Registration Certificate (Form 40, 41)

Registration for importers of biologicals. Documentation, application filing, authority query handling and follow-up until approval.

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Import Licence (Form 10)

Import licence after registration is granted. Documentation, application filing, authority query handling and follow-up until approval.

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Test Licence

Test licences to import or manufacture biologicals. Documentation, application filing, authority query handling and follow-up until approval.

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Manufacturing Licence

Licensing support for biological manufacturers. Documentation, application filing, authority query handling and follow-up until approval.

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Marketing Authorization

Marketing approval for biologicals in India. Documentation, application filing, authority query handling and follow-up until approval.

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NOC and Clarification Letters

NOCs for vaccines, serums and other products. Documentation, application filing, authority query handling and follow-up until approval.

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Post-Approval Changes

Change filings for approved biologicals. Documentation, application filing, authority query handling and follow-up until approval.

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