Drugs

Services for drugs

Select a service to send an enquiry.

Application support for new drugs, including investigational new drugs.

Approval for changes to already approved new drugs. Documentation, application filing, authority query handling and follow-up until approval.

Test licences to import or manufacture drugs for analysis and trials.

Form 40 and 41 registration with import licence support. Documentation, application filing, authority query handling and follow-up until approval.

Drug manufacturing licence guidance for new and existing units.

Licences for wholesale sale and distribution. Documentation, application filing, authority query handling and follow-up until approval.

Bioequivalence and trial permissions from CDSCO. Documentation, application filing, authority query handling and follow-up until approval.

Filing of changes to approved drug products. Documentation, application filing, authority query handling and follow-up until approval.

Gap assessments and compliance support for manufacturing sites.