Pharmaceutical Regulatory Affairs

The Role of the Regulatory Affairs

We specialize in managing regulatory approvals and creating and maintaining related documents. Lema already processes over 1,500 dossiers and Rx OTC switches. From creating a CTD dossier.

The 'Regulatory Activities' area includes all the work required to obtain and maintain a drug approval or registration. Dossiers are at the forefront of this process.

Lema Project Management LLC's Regulatory Affairs Manager compiles drug information on behalf of pharmaceutical companies and presents it in the format required by authorities.

For over 25 years, customers have relied on our expertise in creating and maintaining such dossiers. On behalf of the client, all information relating to clinical studies, medical safety and efficacy studies, drug quality, analytical testing, approved uses, pharmacovigilance, etc., is submitted to one (electronic) common technical document, also known as the eCTD dossier and Marketing approval.