SERVICES
Innovative Biotechnology - Small Molecule -API - Medical Device Solutions for Your Business
Practical Consulting in:-
- Computer System Validation - CSV
- Computer System Assurance - CSA
- Commissioning Qualification Validation - CQV
- Quality Assurance Validation
- Data Integrity
- Project Management
Our Consulting service ensures compliance with current pharmaceutical and medical device regulations, expedites product approvals, and minimizes risks for a seamless market entry.
- CSV/ CSA- Computer System Validation to 21 CFR Part 11, Annex 11, GAMP5.
- CQV - Commissioning Qualification Validation services to ISPE Volume 5.
- Data integrity testing.
- Conduct thorough compliance assessments and gap analyses.
- Assist in preparing documentation for Project Plans, URS, QRA, validation and verification protocols, ERES assessments, RTM, Validation reports, . Preparation and execution of protocols for VPE, Automation and Laboratory systems.
- Project Management - Experience with MS Project and P6.
Biotech Project Management
Our Biotech Project Management service ensures efficient project execution, Master Scheduling, timely milestones achievement, and effective resource allocation to optimize overall project outcomes.
- Create detailed project plans and timelines for clear direction
- Monitor project progress and address any deviations promptly
- Coordinate cross-functional teams for seamless collaboration
