Ensuring regulatory and pharmacovigilance compliance
Guidance on borderline products under MDR: MDCG 2022 - 5 published
The guideline MDCG 2022-5 has been published on 26th April 2022. The proper implementation of legislation on medical devices (pursuant to Regulation (EU) 2017/45 - MDR) and medicinal products for human use (pursuant to the Directive 2001/83/EC - MPD is crucial for correct interpretation and enforcement of these legislations. Several provision to establish demarcation between...
Health care regulation around the world is constantly evolving and is putting increasing emphasis on consumer safety. These changes are often very crucial. Orientation in legislation, individual processes and procedures and also in their time and economic context is not easy. In order to properly evaluate all the possibilities and impacts this area needs to be given the necessary attention.
Therefore, based on our many years of experience and with regard to the permanently increasing demands in the field of regulation of medicinal products, both human and veterinary, medical devices, food supplements and cosmetics, we have established a company whose main task is to constantly monitor the current legislative requirements and offer the most effective way of solution to request of the client. Our services include the entire life cycle of the product, from its development to its successful launch.
Our team of Regulatory Affairs and Pharmacovigilance Managers provide you with a competitive advantage to ensure your products are successfully registered and safely monitored all around EU.
Regulatory House offers regulatory and pharmacovigilance services primarily in the area of medicinal products, cosmetics, veterinary products, medical devices and food supplement.
ING. ZUZANA GRYCOVÁ
CEO - Regulatory Affairs Director
Zuzana used to work as RA director in Archie Samuel since 2010 and as Archie Samuel and partners created in beginning 2014 the joint venture company Regulatory House Zuzana was appointed as CEO and
RA Director. Zuzana has more than 20 years experiences in regulatory affairs – as she used to work at government authority - Institute for State Control of Veterinary Biologicals and Medicines and in the industry. Zuzana served as Head of regulatory affairs ad PhV department in Pliva-Lachema (oncology) and later on in Bioveta (veterinary) as regulatory affairs director and member of the management team of the company.
Zuzana Grycova holds Ing. from University of Chemical Technology, Pardubice.