Through our experience in working with Pharmaceutical, Biotech, and Clinical
Research Organizations, (CRO) we have gained significant knowledge of Industry
and FDA processes and procedures.We have specific experience and understanding
of 21 CFR Part 11, Comprehensive regulatory understanding and experience in
supporting Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and
Good Manufacturing Practices (GMP).
We provide services and solutions in such areas as:
> Clinical
> Data Management
> Regulatory Affairs
> Sales & Marketing
> Quality Assurance
