PRS offers an individualized service for pharmaceutical regulatory affairs.
PRS supports pharmaceutical sponsors in developing products from a wide range of chemical and biological active drug substances. PRS offers consultation in an approachable manner, working with small to mid-sized companies in all phases of drug development. From preclinical programs to registration preparations, PRS consulting maximizes value, compliance, and quality. Averting difficult issues and solving client problems makes Professional Regulatory Services a valuable clinical project partner.
PRS has long-lasting contacts and relationships within the EU and USA pharmaceutical industry, including regulators and clinical opinion leaders. In larger projects PRS works with international partners to achieve registration results competitively, effectively and economically. Progressive continuation of collaborations that started on specific projects has developed into an international network, now connecting expertise with new projects. Professional societies and trade associations and special interest groups influence the network. Additional subject experts (clinical or nonclinical) may be recommended to support a project, upon specific client request.
PRS clients are in the human ethical pharmaceuticals sector, developing reformulations, innovative small molecules, synthetic peptides, monoclonal antibodies, cell therapies.
PRS is also experienced in regulatory procedures such as paediatric investigation plans, orphan designations, and SME declarations which support product development sponsors and bring rewards for development milestones. Working with clients, PRS is qualified to fill the following roles:
- Consultant
- Regulatory Project Manager (international)
- EU Legal Representative
- Chartered Scientist