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Registration of a medical product starts with an official classification  which will determine the documentary requirements, timelines, and fees. Today we are going to share a few misconceptions and the approach to classify a product correctly. Misconception We assume that the classification in the country of origin will be the classification in the country to […]

As pharmaceutical companies worldwide continue to expand their global reach, navigating the intricate landscape of international markets becomes an increasingly complex endeavour. In this era of heightened regulatory scrutiny, pharma companies must be well-versed in the multifaceted world of regulatory affairs in order to successfully expand their operations beyond borders. We’ll explore the indispensable role […]

A Marketing Authorization Holder (MAH) is a local company that is assigned by the Manufacturer to be in charge of all licensing matters.

Does your pharmaceutical company require help complying with regulatory guidelines? Regulatory service providers can provide great assistance

Regulatory intelligence as defined in TRC’s understanding is market research on regulations with the following objectives in mind:  To obtain the most accurate information concerning pathway , application type , requirements , timelines, and fees of the pharmaceutical or medical products to be registered  Impact of a certain regulations on existing pipeline of products  The feasibility of using existing dossier to apply for marketing authorization in the territory of interest  Get a framework of how a certain product is regulated in a certain market as a global regulatory strategy  To examine a potential question e.g a lack of certain documents such as not having PIC/S GMP or not meeting certain criteria e,g not having Zone IVb stability data which is essential in ASEAN countries or not having prior approval in reference agencies of the territory could be critical for registration in the case of biosimilars

Due to the nature of the healthcare and pharmaceutical industry, products and services produced for medical use need to undergo strict processes and meet certain requirements before they are allowed on the market. As the industry continues to grow and evolve, ensuring safety, efficacy, and quality through regulatory affairs management becomes even more crucial in […]