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.
The Regulatory Affairs Unit is committed to ensuring compliance with all applicable national and international regulations. We maintain up-to-date knowledge of evolving laws and regulatory guidelines pertaining to pharmaceuticals, supplements, and natural health products. We collaborate closely with other internal departments to ensure adherence to all legal and regulatory requirements. Due to its direct and ongoing interaction with the IFDA, our unit plays a crucial role in managing regulatory inspections, providing required reports, and responding to inquiries and requests from relevant regulatory authorities.
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)
Furthermore, our team maintains comprehensive knowledge of various regulatory pathways, including reliance procedures, Mutual Recognition Procedures (MRP), and all other established regulatory mechanisms. We prioritize direct communication with international partners in Asia, Europe, and the Americas for whom we manage regulatory procedures within our designated territory. Our focus is on the efficient and effective management of these procedures. We maintain close communication with manufacturers, providing support throughout the registration process, particularly during critical phases, to ensure timely completion. This dedicated support facilitates the acquisition of marketing authorizations, ultimately enabling the successful commercialization of their products. We have a proven track record of successfully completing pre-market quality assessments and lifecycle registrations. To ensure transparency and keep our partners informed, we streamline the registration process for both pharmaceutical products and raw materials, proactively addressing any identified deficiencies to mitigate potential delays. Our expertise also extends to the meticulous registration of all general and specialized natural health supplements and products, encompassing their domestic production, contract manufacturing, and importation, while adhering to the highest quality standards. This includes:
Registration of international sources of pharmaceutical raw materials.
Securing licenses for the overseas production of pharmaceutical products.
Furthermore, we maintain direct and consistent communication with the Iranian Food and Drug Organization (IFDA), the primary regulatory authority, to ensure the timely completion of all necessary procedures. Their approval is essential for the registration and licensing of pharmaceutical products. We also facilitate the acquisition of marketing authorizations from international companies, contingent upon approval from the IFDA.
Baby milk and complementary products and OTC
I am Dr. Samira Mohamadi Izad as the Qualified Person in the Nogen Pharmed Caspian nutraceutical section; I play a crucial role in safeguarding public health. My primary responsibility is to ensure the highest quality, safety, and efficacy of all medicinal products released into the market As a highly motivated and results-oriented Pharmaceutical Doctorate with over 15 years of experience in the pharmaceutical industry, I possess a strong foundation in regulatory affairs, quality assurance, drug development, clinical trials.
If you want to keep in touch with me, please feel free to reach out. My email is: [email protected] To contact me by phone, please call +98 21 88684105 and press the number 102.
Regulated and medicine products
I am Samira Bani Ali, As a Pharmacist, I am committed to ensuring the highest quality standards in pharmaceutical manufacturing. I can monitor all aspects of drug production by adhering to international guidelines. My expertise lies in implementing robust quality control measures and adhering to regulatory guidelines to guarantee the safety, efficacy, and consistency of our pharmaceutical products. I possess a deep understanding of GMP principles and regulatory frameworks, enabling me to conduct thorough quality assessments.
If you’d like to stay connected, You can email me at: [email protected] For phone contact, please dial +98 21 88684105 and select the number 102.
