As a result of this agreement, Pierrel Research, through the cooperation with Dr. Regenold, will bring strong operational regulatory capacity, regulatory affairs consulting expertise, and an indepth understanding of global regulatory requirements and submission strategies to assist its clients in preparing and filing clinical trial submissions and full registration dossiers for marketing authorizations of any type of product (e.g. Pharmaceuticals, Medical devices, cosmeceuticals and food supplements).
Pierrel Research quality assurance and medical writing professionals will ensure regulatory compliance for any clinical program and support clinical operations in advancing clinical trials under high quality standards.
In addition, the access to “regulanet®”, a network of regulatory agencies with members throughout the world, with coverage in over 80 countries and more than 400 members and experts, allows Pierrel Research to provide advice and assistance on any national and international project and marketing authorization procedure, such as decentralized, mutual recognition and centralized applications within Europe and national procedures in USA, Canada, CH, SEE, Russia, Ukraine, Latin America and with other regulatory authorities worldwide. Further regulatory services include the Orphan Drug Designation (ODD) and post-approval maintenance. “Partnering with this very qualified international regulatory company and the regulanet® network”, - said Luigi Visani, Chief Executive Officer of Pierrel Research - “will enable us to provide global regulatory services and strategic input from the early stage of a clinical development program for new drugs or devices. We can assist our clients in preventing future delays in their drug development programs, by interpreting correctly regulations and guidelines, developing strategy for all technical aspects of drug development, from quality to preclinical and clinical, designing and managing a complete registration program, from phase I up to the final dossier preparation and submission, including the assessment of the market access requirements from the early stage of development. Pierrel Research – Dr. Visani, continued – with this agreement, qualifies as a leading International CRO with strong clinical and regulatory expertise and organization “Dr. Juergen Regenold, Managing Director of Dr .Regenold GmbH, commented ,”We are pleased to announce this partnership with Pierrel Research, a global CRO, which will enable us to provide a full range of regulatory services to Pierrel Research and their clients. This partnership is illustrative of our strategy to link with strong, reputable organizations through which we can provide our core regulatory services and market access support through all stages of a drug or device’s development.
In addition, through our regulanet® network, we are able to provide Pierrel Research with global coverage to assist their clients in both national and international development projects. We look forward to working with Pierrel to add value to their offer and assist clients to commercialise their developments through providing proactive regulatory support”.
Pierrel Research International AG, is a global contract research organization providing consultancy and full services for the research and development of new molecules and drugs. Our clients include Pharmaceutical, biotechnology, medical device, academic and non-profit life science organizations. With operations in over 20 countries, Pierrel Research operates both in Europe and North America, with a strong commitment to help clients accelerate their development programs by delivering results and quality in a timely manner, through the application of innovative technologies, therapeutic and regulatory expertise and a fast responsive and flexible organization.
For more information visit: www.pierrel-research.com
Dr. Regenold GmbH is specialised in national and international regulatory affairs. Founded in 1994, Dr. Regenold GmbH has its main office in Germany and joint venture partners in the UK to cover the UK and Ireland and Croatia for South East Europe. In addition Dr Regenold founded and leads regulanet®, a network of regulatory affairs consultancies with members in over 80 countries throughout the world. Established in 2001, member companies offer services to a wide variety of national and international healthcare and pharmaceutical clients, helping them understand the complexities of the different regulatory requirements and providing solutions.
For further information visit: www.regenold.com or www.regulanet.com
