ACTD and eCTD Overview – PharmaShare.in OVERVIEW OF ACTD AND eCTD 1. ACTD – ASEAN COMMON TECHNICAL DOCUMENT ACTD is the common format for submission of dossier in ASEAN countries. ASEAN means Association of South East Asian Nations – 10 countries: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam. ICH CTD is for … Read more
Overview of Common Technical Document (CTD) – PharmaShare.in OVERVIEW OF COMMON TECHNICAL DOCUMENT (CTD) The Common Technical Document The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD – Common Technical Document) has revolutionized the regulatory review processes, led to harmonized electronic submission that, in turn, enabled implementation … Read more
Drug Registration in Europe: EMA Centralized vs DCP vs MRP vs National Procedure Drug Registration in Europe: Complete Guide to EMA Approval – Centralized, Decentralized, MRP & National Procedure Last Updated: September 2026 | By PharmaShare.in – Regulatory Affairs Simplified Quick Summary: Europe is the 2nd largest pharma market but the most complex. A medicinal … Read more
US vs Canada: Complete Guide to Drug Registration Process – NDA, ANDA, 505(b)(2) vs NDS, ANDS US vs Canada: Complete Guide to Drug Registration Process – NDA, ANDA, 505(b)(2) vs NDS, ANDS Last Updated: September 2026 | By PharmaShare.in – Regulatory Affairs Simplified Quick Summary: The US and Canada are the most lucrative pharma markets … Read more
Overview of Various National Filing Terminologies: Regulated vs Emerging Markets – US, EU, Japan, Brazil, Tanzania, Russia, Hong Kong Quick Summary: Pharmaceutical industry is one of the most highly regulated industries to protect health of masses. While world regulations are harmonizing, they can be divided into 4 major categories – North America (US, Canada), Europe … Read more
Regulatory Filing in Pharma: How to Develop One Drug for Global Markets – US, EU, and ROW Quick Summary: Regulatory requirements of various countries vary. It is challenging to develop a single drug which can be simultaneously submitted in all countries. So regulatory strategy must be fixed BEFORE development starts, otherwise you will get major … Read more
QbD Elements in Pharma: QTPP, CQA, CMA, CPP, and Control Strategy Explained Practically Quick Summary: QbD is not theory. It has 5 clear elements. First we define QTPP – what quality we want for patient. From QTPP we derive CQA – what must be controlled. Then we find CMA (material) and CPP (process) that impact … Read more
Process Analytical Technology (PAT) Techniques: How to Move From Testing Quality to Building Quality in Real-Time Quick Summary: PAT is process analysis in real-time. Instead of taking sample to lab and waiting 2 days for result, PAT measures quality during manufacturing itself. It is a shift from product-centric testing to process-centric understanding. At-line, on-line, in-line … Read more
Knowledge of Quality by Design (QbD) in Pharma: From Concept to Design Space & Control Strategy Quick Summary: You can’t test quality into drug products. Quality should be built in by design. That’s the core of QbD. In this blog, I will explain QbD in simple language – What is QbD, why ICH Q8, Q9, … Read more
GAMP 5 in Pharma – What It Really Is, Why FDA Loves It & How to Implement It Practically My Quick Take: GAMP 5 is not a regulation. It’s a guideline – a guidebook written by ISPE to help us validate computerized systems in a simple, risk-based way. If 21 CFR Part 11 tells you … Read more
