- Program Managers
- Project Managers
- Project Tracking & Controls Specialist.
- Assessments
- Audits
- Warning Letters
- Remediation
- Compliance Programs
- Policies & Procedures
- Factory Acceptance Testing
- Design Review & Qualification
- Commissioning
- Documentation Requirements
- Professional Engineers
Pharmaceutical & Biotech
CAREERS |
Our Compliance Group specializes in supporting the engineering, construction, manufacturing and distribution of health care products. We understand your needs and complaince requirements and have professionals to support your efforts. We have extensive experience in the manufacturing of Liquids, Solid Dosage, Parenterals, Fermentation, Blood Products, Medical Devices and related Computerized Systems.
Our team developed and implemented many plant wide systems to assure compliance. Our extensive database includes formats and templates to get the project off and running and maximize the efficiency in development. Our expert staff is ready to implement and assist you in many different areas.
- Validation Master Plan
- Qualification Approach
- Validation Procedures
- Manufacturing Equipment
- Lab Equipment
- Utilities
- Analytical Methods
- Sampling
- CV Protocols
- IT & Manufacturing Systems
- Software & SAP
- SDLC
Laboratory
- Methods Development
- Procedures
- Lab Support
- Sampling Plans
Services
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