Regulatory Affairs
The Critical Role of PK and PD Studies in Regulatory Affairs Submissions
Pharmacokinetics (PK) and pharmacodynamics (PD) studies are essential pillars of drug development, directly influencing regulatory submissions and approvals. These studies ...
505(b)(2) vs. ANDA | Choosing the Right FDA Pathway for Drug Approval
Navigating the U.S. regulatory landscape requires a clear understanding of approval pathways, especially when deciding between 505(b)(2) New Drug Applications ...
NME vs. NCE | Understanding the Difference in Drug Development
In regulatory affairs, we often hear the terms New Molecular Entity (NME) and New Chemical Entity (NCE) used interchangeably. However, ...
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 ...