Our Mission
Serve as a trusted partner to our clients by provding skilled professionals to execute their short term and long term strategies to meet their business and regulatory requirements.
About Us
- Founded in 2021 to meet the increasing demand of genuine skilled professionals.
- Over 35 years of experience in leading Information Technololgy, Technology and Regulatory Compliance and Quality System functions within Life science companies like Forest Lab, Actavis, Allergan, Ortho Clinical Diagnostics, JnJ, Bayer, Medidata, Greenwich Biosciences, Jazz Pharmaceuticals etc.
- Implementation of GxP applications in Clinical, Regulatory, Quality, Laboratory, Manufacturing, Drug Safety, Information Technology areas.
- Validation of Software as a Medical Device (SaMD), Mobile Applications..
- Phase based and risk based Quality Management System processes.
- Extensive experience with Veeva -QualityDocs, eQMS, RIMS, and eTMF
Services
System Implementation and Support
- Computer System Validation
- Cloud Compliance
- Instrument Qualification
- SOPs writing
- System Implementation
- System Administration
Audit
- GxP Vendor Audit
- Clinical Site Audit, Clinical Lab Audit
- Internal process and System Audit
- Data Integrity Audit
Growing Clients
Contact Us
Dublin, CA 94568
support@biopharmatechsol.com