Services
Research
Services
Regulatory
Services
Clinical Studies
Services
Implementing the Highest Standards in Research & Development
We work with select partners to successfully launch medical devices and drugs in over 30 countries. With 55+ years of combined experience, our leadership team, has in-depth knowledge of regulatory development from basic research and IP creation to clinical studies and regulatory filings.
RESEARCH SERVICES
Basic Science, In-vitro Studies, Proof-of-Concept, Modelling, Intellectual Property Development
REGULATORY SERVICES
Setup and Compliance with Quality System Regulations (21 CFR); CE Labeling; FDA 510(k) and De Novo Submission; IDE; and IND. Submissions of pre-INDs; INDs; NDAs; PMAs; 510(k)s; De Novo applications; CE and European regulatory support
CLINICAL STUDIES SERVICES
Clinical Study Planning, Protocol Development; Clinical Sample Manufacturing; Toxicology (in vitro and in vivo); Statistical Modeling; IRB and EC Submissions; Patient Recruitment; Study Monitoring and Management; Data Analysis