Service

A thorough understanding of the complicated regulatory requirements is required to enter the vast field of pharmaceutical products on international markets. At Saintroy Lifescience, we provide companies with Drug Regulatory Affairs (DRA) consulting services to help them plan and manage their pharmaceutical and medical product development programs. Defining country-specific regulatory strategies right at the nascent stage of product development allows us to eliminate potential roadblocks en route to a successful product launch.

Regulatory Services include the following:

     The registration service is:

• Preparation, review, and submission of the DMF (CTD format)
• Review and preparation of the dossier
• For dossier registration
• COA and COPP registration
• Legalization

        Post-approval revisions:

• Reregistration of a product and
• Renewal of the site as scheduled
• In the post-approval lifecycle
• Compilation and publication of the report

            The Pre-Registration Service is offered as follows:

• DMF for Drug Products
• Document Development and Preparation
• Content creation and document preparation services