REGULATORY SERVICES - 'The law is above all'

Provenance provides regulatory services to facilitate all stages of drug development. Provenance accomplishes this by providing strategy planning to obtain effective and efficient pathway towards required regulatory approvals, Provenance's in-house team of regulatory experts help our clients in meeting challenging timelines and budget expectations, work flows and processes are designed to provide cost effective study management solutions towards regulatory authorizations, Provenance's in-house team has expertise in applying for regulatory dossiers approvals in varied therapeutic indications in multi phase studies.

Services offered

Marketing:

• Registration of products in India for import, marketing and manufacturing.

Clinical:

• Regulatory approvals from Phase I-IV clinical trials including new indications and specialty studies
• Regulatory approvals for conducting BA/BE studies
• Periodic safety updates reporting
• Authorizations for export/import of drugs/biological samples for testing