Areas of Consultation:
Evolution Scientific offers a wide range of Technical Consultation in the areas of:
- Change Controls
- Gap Analysis
- Laboratory & Methodology Master Plans
- Process Validation and Compliance
- Risk Assessments
- Transfers
ESi is a certified ISO 9001 company that is fully versed in current FDA/EU/USP requirements including cGMPs (21 CFR Part 210 & 211), Electronic Records (21 CFR Part 11), and Medical Devices (21 CFR Part 820).
Evolution Scientific Consulting Services:
- Change Control and Validation Master Plan Assistance
- Gap Analysis
- GLP and GMP auditing services for analytical or manufacturing environments
- Internal Documentation Audits
- Laboratory Method Validation Support
- Methodology Transfer Support
- Risk Assessment
- Vendor Audits
- 21 CFR Part 11 Assessments
Contact Us to find out more about consulting services offered to better help you achieve your compliance goals.
ESi provides required Regulatory Compliance Services to the Pharmaceutical, Biotech, Medical Device and other regulated industries. Evolution Scientific, Inc. is privately owned certified Veteran Owned Small Business, a registered ISO 9001 company, and has earned ISO/IEC 17025 Accreditation from A2LA.
