The manufacturer shall establish and maintain a record for each batch of medical device or in vitro diagnostic medical devices that provides traceability and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved. 7.5.1.2 Control of production and service provision—Specific requirements 7.5.1.2.1 Cleanliness of product and contamin ...

We also look at the drug regulatory rules from a perspective of customs laws to avoid unnecessary complications for the client while importing their products. For imports, we assist the client in facilitating import of goods with services like applying for import permits, customs clearances, licenses, documentation, etc.