Integrated consulting services for development of new medicines and medical devices
Services
Our pharmaceutical consulting services include strategic and tactical product development, clinical trials, regulatory affairs, sponsor legal representation, product safety, and holding designations for clients (e.g., orphan drugs, SMEs).
Global clients
We have more than 20 years of proven success in providing effective solutions to the global pharmaceutical/biotech and medical device industries, helping to bring innovations to market efficiently and safely.
We support businesses across the globe
Latest Insights
Knowledge Hub
General Consulting and Trouble Shooting
We have expertise in medical device development planning and advising on strategic regulatory planning and compliance. We can help you navigate the increasingly complex regulatory environment regarding medical devices and combination products (including drug-device and device-drug combinations) and in-vitro diagnostics (EU, UK and US Medical Devices Regulation).
Strategic and Tactical Product and Device Development
End-to-end strategic planning and tactics to improve time to market, control costs, plan timelines, and maximise the probability of successful regulatory approval.
Regulatory Affairs
We guide you through the regulatory process, helping you to navigate the regulatory environment and trends across the EU, UK, and US. We work with you to present your product and development strategy to regulatory agencies, ensuring legal requirements are met along the way.
Pharmacovigilance and Medical Device Vigilance
We have systems and expertise that help you build a regulatory-compliant pharmacovigilance or medical device vigilance function, including a turn-key outsourced solution.
EU and UK Sponsor Legal Representation
Based on a deep knowledge of the regulations and practice, we offer a compliant and knowledgeable sponsor legal representation service for the EU and UK.
OUR ASSOCIATES
