Drug Product Authorizations

DDReg is an astute Regulatory Affairs guide for new market authorizations / initial submissions to global clients, for all types of products (New Chemical Entity (NCE), Generics, Medical Devices, Active Pharmaceutical Ingredient (API) / Bulk Drugs, Over the Counter (OTC) / Consumer Healthcare products) and Formulations (solid oral, liquid oral, parenteral dosage forms, biologicals etc.). DDReg has a strong team having experience and expertise in handling market authorizations of all major HAs  like, the United States Food and Drug Administration (US FDA), the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA), the Therapeutic Goods Administration (TGA), South African Health Products Regulatory Authority (SAHPRA), Ministry of Health (MoH) of Russia, Latin America (LATAM), Middle East and North Africa (MENA), Asia Pacific (APAC), Association of Southeast Asian Nations (ASEAN), Commonwealth of Independent States (CIS) regions, and World Health Organization (WHO).

DDReg has gained expertise in pre-submission technical Data reviews, gap analysis, dossier compilation, Regulatory content authoring, validation and final submission of various global new product authorization applications.

Our services in this area include

  • Review of Technical Data on Finished Formulations as per country requirements
  • Gap Analysis and Remediation Advisory
  • Authoring of Technical Sections of Dossiers
  • Dossier authoring, compilation & Publishing
  • Labeling document reviews
  • Submission to Agency,
  • Agency Query responses

Other Services

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