Regulatory Certification

Certification Services for Regulatory Submissions

Administrative documents are an integral component of regulatory submissions and constitute key certifications. These can include Letter of Authorization (LOA) Certificate of Pharmaceutical Product (CPP), Certificate of Suitability (CEP), Good Manufacturing Practice (GMP) etc. Regulatory agencies require manufacturers to have these certificates notarized, apostille, and legalized if they wish to enter a new market which guarantees the authenticity and ultimately the quality of the product to expedite market access.

Legalization practices vary across different regions; certain agencies may require document submission to be done online while others require in-person submission. Similarly, depending on the country, a certificate need not be legalized if it has been notarized and apostille. Navigating through such requirements for certificate verification can be challenging for manufacturers that wish to penetrate an unfamiliar market or region.

DDReg has experience in vast majority of developed and emerging markets that require administrative certification to be notarized, apostilled, and legalized for timely submissions. DDReg’s local representatives liaise with the appropriate Embassy and Chamber of Commerce to get administrative certificates notarized, apostilled, and legalized for timely submission of dossiers. Whether they are regional differences in certificate requirements, translation services, or physical certificate submission, DDReg covers all aspects of verifying administrative certificates.