Regulatory Affairs
Regulatory CMC Comparison | US vs. EU Market
Understanding the regulatory requirements for Chemistry, Manufacturing, and Controls (CMC) is crucial for global product success. Here’s a quick comparison ...
Regulatory Affairs A-Z | The Compliance Alphabet
A – ANDA (Abbreviated New Drug Application) – The golden ticket to launch a generic drug in the US—only if ...
Site Master File (SMF)
For pharmaceutical and medical device manufacturers, a Site Master File (SMF) is more than just a document—it’s a blueprint of ...
Letter of Authorization (LOA)
In the pharmaceutical industry, Drug Master Files (DMFs) play a critical role in maintaining the confidentiality of proprietary information related ...
Marketing Authorization Holder (MAH)
Any company, firm or non-profit organization, which holds a marketing authorization granted by the European Medicines Agency (EMA), is called ...
Understanding CEP, DMF, CADIFA and ASMF
CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) DMF (Drug Master File) CADIFA (Certificado de Adequação de ...
Post-Approval Changes in Pharmaceutical Industry
Post-approval changes in pharmaceutical companies refer to any modifications made to a drug product or its manufacturing process after receiving ...
Key Aspects of SUPAC Guidelines
SUPAC (Scale-Up and Post-Approval Changes) is a set of guidelines issued by the U.S. Food and Drug Administration (FDA) to ...
Drug Master File (DMF)
A DMF is a confidential document submitted to the FDA by a pharmaceutical manufacturer, containing detailed information about the facilities, ...
Regulatory Authorities
Regulatory authorities enforce legal frameworks for new drug products or medical devices approval in market. For example, US FDA oversees ...