Regulatory Affairs
Key Parts of DMF to Review
When developing generic products, reviewing the Drug Master File (DMF) is a critical step. Finished product manufacturers are expected to ...
EU Market Authorization: A Strategic Decision Tree for Pharma Professionals
Navigating the EU regulatory landscape is critical for successful product launches. Choosing the right authorization pathway is not just procedural, ...
New Biosimilar Era | FDA’s Biggest Shift
FDA has delivered the most consequential policy change in two decades, a shift that fundamentally transforms how our industry will ...
Common Technical Document (CTD)
The Common Technical Document (CTD) is one of the most significant harmonisation achievements in global regulatory science. Before CTD, every ...
Medical Device Classification | EU vs. USA
Medical device regulations differ significantly between the EU (MDR 2017/745) and the US (FDA 21 CFR 860), impacting market entry ...
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 ...