Regulatory Consulting Firm: DDReg Pharma

Regulatory Affairs and Pharmacovigilance in Austria Austria occupies an important position within Europe's pharmaceutical regulatory network. For companies entering the Austrian market, maintaining an existing medicinal product, or coordinating regulatory activities across the European Union, compliance requires more than obtaining an initial marketing authorization. Regulatory affairs and pharmacovigilance in Austria are closely connected throughout the product lifecycle. Regulatory strategy influences market-entry decisions, submission pathways, product information and post-approval obligations. Pharmacovigilance generates safety information that can, in turn, trigger regulatory assessments, product-information changes, risk-management activities or further communication with authorities. The Federal Office for Safety in Health Care is Austria's national authority for medicines, medical devices, blood and tissues. BASG states that its responsibilities include drug approval, c...

The UK regulatory environment continues to evolve, creating both opportunities and compliance challenges for pharmaceutical, biotechnology and medical device companies. For medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) remains central to marketing authorisation, post-authorisation compliance and pharmacovigilance oversight. At the same time, the UK is developing more reliance-based and digitally enabled regulatory pathways. The MHRA's International Recognition Procedure (IRP), for example, provides routes that can leverage certain approvals from trusted international regulators. The procedure and associated guidance were updated as recently as July 2026. For companies operating across multiple markets, UK compliance therefore cannot be treated as a one-time submission exercise. Regulatory Affairs (RA), Pharmacovigilance (PV), CMC, regulatory intelligence and product lifecycle management increasingly need to operate as connected disciplines. This article ...

Regulatory Affairs and Pharmacovigilance in Canada Introduction For pharmaceutical and medical device companies entering or expanding in Canada, regulatory compliance is not limited to obtaining a marketing authorization or device licence. It is a continuing lifecycle activity that spans regulatory strategy, submission preparation, safety surveillance, labeling, post-authorization changes, and ongoing interaction with Health Canada. This is where regulatory affairs and pharmacovigilance increasingly intersect. A regulatory strategy may determine how a product enters the Canadian market, while pharmacovigilance activities generate safety evidence that can influence labeling, risk management, regulatory submissions, and post-market decisions. The quality of information flowing between these functions can therefore have a direct impact on compliance and patient safety. Health Canada has also continued to refine its regulatory expectations. Its current guidance on drug submission...