Services
Medical & Pharmaceutical Life science Regulatory Affairs & Quality Assurance
Our know how ensure certain times and budgets in the projects
Our service package covers strategic consultancy in the entire device development process, starting from design, to the implementation of clinical studies and validation trials; offering flexible solutions for all our customers’ needs and cover regulatory and quality management, for compliance in Medical Devices & IVDs with experience in international Regulation assessment as
- EU Regulation, Medical Device Regulation (EU) 2017/745 - In Vitro Diagnostic Regulation (EU) 2017/746
- FDA (USA)
- Saudi Food and Drug Authority (SFDA)
- National Medical Products Administration China (NMPA)
- Medicines Healthcare Regulatory Agency UK (MHRA)
- Australian Register of Therapeutic Goods (ARTG).
Our services cover regulatory and quality management, for compliance in
- Pre-market Technical documentation, risk management clinical evaluations, performance evaluations,
- Device registrations
- Post-market surveillance
- Quality assurance
Over the past 40 years, the team has accumulated more experience in product registration, covering all segments of medical devices. With a complete chain of regulatory logic and modular services, we provide customized services to meet customer needs. With the constant change in regulations, application strategy and risk assessment are very important for the applicant. It is essential to understand the regulations and use previous experiences to increase the success rate. Our regulatory affairs team has a diverse professional background and provides accurate and in-depth regulatory interpretation, offering our clients customized regulatory affairs services through a strong legal office.
