An agreement between Pharmaceutical Regulatory Services Inc., (PRS) of Princeton and German-based Dr. Regenold GmbH (CQ) has expanded the reach of PRS's pharmaceutical regulatory clinical research services to over 80 countries in Europe, the South Pacific, Asia, Latin America and Africa as well as the United States.
With the new collaboration, 210 employees and 150 associates now provide regulatory support for new drug development as well as regulatory maintenance services of marketed products throughout most of the world, according to PRS president Jurij Petrin and Jürgen Regenold, GmbH Dr. managing director. “By broadening our reach with highly trained regulatory affairs specialists in over 80 countries, we are better able to serve our clients in the pharmaceutical, biotech and medical devices businesses,” said Petrin, a physician.
“We bring extensive regulatory experience and presence in all regions of the world, which we believe is unique for companies of our size. Our20business model enables us to keep overhead low while at the same time our team’s regulatory expertise in drug development and post-marketing services adds significant value and understanding of our clients’ projects, which competitors may not be able to match,” said Regenold,
“Every country has different business requirements and different processes to achieve regulatory approval,” Petrin said. “Both partners are drug development companies with in-house experience in getting regulatory approval to bring a drug to market and keep it there, one country at a time. We manage and support the R&D process from preclinical through clinical stages and on to post marketing and sales, throughout the entire life cycle of the product. In addition, we serve as regulatory liaisons to business operations including marketing, sales, legal and public relations.”
The alliance’s offerings include all services associated with the regulatory life cycle management of marketed products, as well as regulatory support of new drug and generic drug development. The alliance also offers worldwide drug safety and pharmacovigilance services for products in development, as well as in the post-marketing phase. Last but not least, both companies often provide assessments of local medical need and business opportunities around the world.
Petrin founded PRS in 2000 and Regenold founded Dr. Regenold GmbH in 1994 as cost effective alternatives to the big pharmaceutical company model, with their headquarters in Princeton, NJ, and Badenweiler, Germany, respectively. Regenold founded also “regulanet,” a network of independent RA-service providers, operating under common quality standards and using common submission tools.
“We have significant in-house muscle and capability. We can offer the customer one point of contact for the spectrum of services and coordinate the services to be performed via our network-partners/associates. This network allows us to use local partners to see a drug through to approval in most countries of the world,” Petrin said
- Tom Hester