A thorough understanding of the complicated regulatory requirements is required to enter the vast field of pharmaceutical products on international markets. At Qualence Life Sciences, 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
