Delta Pharma-AL provides Regulatory Affairs service to its Partners and operates as an outsourced company as well ensuring compliance with applicable laws and regulations, developing regulatory strategies and submissions and following up with Authorities to ensure approval and placing of the product in the market in a timely manner.
Delta Pharma-AL supports its Partners by providing all necessary regulatory information, with the latest up-to-date information and by helping them to better understand the local requirements including the following:
– New product registrations: evaluation, preparation of submission dossier and following through the application with local Health Authorities.
– Maintenance of the current registrations (variations & renewals).
– Translation of the product information for submission during registration or renewal process.