and Recruitment for R&D Partners in the
U.S. and Abroad.
Applied Biology's mission is to leverage innovation into life changing therapies and diagnostics.
Bringing Ideas to Life
Our team has experience in successfully launching medical devices and drugs in over 30 countries. By bringing our own ideas to life, we have developed in depth knowledge of regulatory directed development from basic research and IP creation to clinical studies and regulatory filings.
We offer select partners (with novel innovations in dermatology and women health) the following spectrum of services.
Our Services Include:
Product Conceptualization and Design
Research Services, Intellectual Property (IP) Strategy and Development, Design History File Development
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