• Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance

    We appreciate your interest in Freyr’s webinar - “Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance.” We are happy to announce that the session was successfully completed on December 11, 2018.

    But with your keen interest on CER Authoring as per updated MED DEV 2.7/1 Rev 4, we assume you would like to go through the session. In that regard, let us share with you a FREE copy of webinar recording.

  • Pharma Regulatory Services in Turkey

    Overview

    Increased healthcare spending in Turkey has resulted in growing demand for medicinal products. As the Turkish Medicines and Medical Devices Agency (TMMDA) reviews and approves the medicinal products’ marketing in the country, aligning with its unique requirements for compilation and submission of dossiers in CTD format and conversion to paper format for legacy products can prove quite challenging without expert assistance.

  • Pharma Regulatory Services in Egypt

    Overview

    Egypt’s burgeoning demand for medicinal products due to demographic growth and urbanization makes it one of the top markets in Middle East and Africa. All drug products are required to be approved by the Egyptian Drug Authority before distribution or marketing in the country. From decoding the Regulatory framework to aligning with the Regulatory requirements, being compliant with Egyptian Drug Authority might be a tedious task for new market entrants.

  • Regulatory Services in Iraq

    Overview

    Given the fast growth of Pharmaceutical market in the last couple of years, Iraq seems to be in good fortune to offer good investment opportunities for foreign medical device and medicinal product manufacturers. The State Company for Marketing Drugs and Medical Appliances (KIMADIA) under the surveillance of Ministry of Health regulates marketing authorization, registration, Regulatory inspection, import control, licensing and all other Regulatory procedures.

  • Regulatory Services in kuwait

    Overview

    With huge share of imports and certainly low volume of local manufacturing, the State of Kuwait portrays a better scope of foreign medical device and medicinal product manufacturers entering the market. While doing so, given the strong Pharma Regulatory structure of Kuwait, foreign manufacturers without a clear-cut market awareness might encounter procedural challenges to obtain licenses, registrations and product approvals from the State of Kuwait Drug and Food Control Administration.

  • Regulatory Services in Bahrain

    Overview

    With the fastest growing economy and being one of the advanced pharmaceutical and healthcare systems in the region, the Kingdom of Bahrain is a welcoming destination for medicinal products and medical device manufacturers. The National Health Regulatory Authority (NHRA) oversees product / device registrations and respective regulatory procedures. Though the region recognizes certifications from international renowned Regulatory bodies, navigating through demanding obligations might require thorough knowledge on the market.

  • Regulatory Services in Yemen

    Overview

    With a rapidly growing economy and with the dominating scenario of foreign imports, the Republic of Yemen intend to attract many foreign medicinal products and medical device manufacturers to invest in the region. To obtain successful market entry, however, manufacturers need to get approvals from the Supreme Board of Drugs and Medical Appliances (SBDMA) and the Ministry of Public Health, agencies responsible for regulation of pharmacy practices, registrations and drug procurement.

  • Regulatory Services in Uganda

    Overview

    Pharmaceutical and health care sector in the Ugandan landscape is diversified with public and private sector involvement. With the major imported medicines’ share the Ugandan Pharma market offers substantial growth opportunities for foreign medicinal products’ manufacturers. However, to enter the region, manufacturers must get approvals from National Drug Authority, Uganda. Enroute, not only the complex Ugandan Regulatory regime, but also the critical Regulatory procedures challenge the manufacturers to obtain market authorizations.