Regulatory Affairs

Nogen Pharmed: Navigating Regulations, Ensuring Compliance

The primary responsibility of the Regulatory Affairs Unit is the preparation, compilation, and submission of all necessary documentation required by the Iranian Food and Drug Organization (IFDA), the national regulatory authority, for the registration of pharmaceutical products, including both prescription and over-the-counter (OTC) medications, as well as nutritional supplements and natural health products. Our team manages the registration process for these products through to final approval and licensing. We also maintain a comprehensive understanding of the legal and regulatory framework governing the import, domestic production, contract manufacturing, and distribution of pharmaceutical products.

Furthermore, our unit is responsible for securing all necessary import permits for raw materials used in the manufacture of pharmaceuticals and supplements. We prepare comprehensive scientific and technical documentation, including Common Technical Documents (CTDs) for pharmaceutical registrations, as well as Product Master Files (PMFs), Product Information Application Forms (PIAFs), and other required documentation for supplements and natural health products.

Regulatory Submission Management

The unit manages all aspects of regulatory submissions, from documentation to licensing, for diverse product types and raw material import permits.

Deep Regulatory Knowledge and Compliance

full compliance by maintaining expertise in national and international regulations, including import/export, production, distribution, and various regulatory pathways.

Proactive Communication and Collaboration

ensures efficient regulatory processes through strong communication and collaboration with internal and external stakeholders, including the IFDA and international partners.

Regulatory Expertise with Proven Success

demonstrated by successful of complex regulatory processes, including specialized product registrations, approvals, assessments, lifecycle management, and natural health product registration.

Regulatory Affairs

Nogen Pharmed: Precise Documentation, Successful Registrations

Regulatory Affairs Experience:
Our Regulatory Affairs Unit possesses extensive experience in navigating complex regulatory processes, including:

Successful registration of monoclonal antibodies with the national regulatory authority.
Registration of peptide-based products within the modular business framework.
Registration of oncology and anti-neoplastic medications.
Preparation and submission of site master files for regulatory approval of manufacturing facilities.
Registration of a diverse range of antibiotic and anti-diabetic medications.
Registration of numerous Active Pharmaceutical Ingredients (APIs) with Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs)