What is Qualified Person (QP)?
The Qualified Person (QP) is very important in pharmaceutical manufacturing as it ensures that medicinal products adhere to all required quality and regulatory specifications before being released in the market. Pharmaceutical regulations in most countries and especially in the European Union require this role and it is essential to the safety, efficacy, and compliance of drugs.
What is a Drug Regulatory Authority?
In the pharmaceutical sector, integrity of drug development, production, and distribution matters most. The main role of Drug Regulatory Authority (DRA) is to ensure that the pharmaceutical product is of the set standard of safety, quality and efficacy.
What is Claim Substantiation?
Claim substantiation in pharmaceutical business is a very important process whereby all claims that are related to products such as therapeutic, preventive and supportive ones are supported by reliable scientific facts. The practice is not only a regulatory liability but also a pillar of an ethical marketing practice and patient safety.
What is Clinical Regulatory Writing?
Clinical Regulatory Writing is a highly specialized type of medical writing which facilitates the development, approval and post marketing surveillance of drugs and medical devices. It includes developing the necessary materials needed by international health regulators, including the FDA, EMA, and MHRA, when performing the clinical trial and regulatory submission procedure.
What is Electronic Common Technical Document (eCTD) Software?
Regulatory submissions are an important aspect of drug development and approval in the pharmaceutical industry. Electronic Common Technical Document (eCTD) has been developed to standardize and simplify the process of providing information to regulatory bodies. The eCTD is an internationally recognized format designed specifically to improve the submission, review, and lifecycle management of regulatory information related to pharmaceuticals.