Cleanroom Regulatory & compliance consulting
Our Cleanroom Regulatory and Compliance Consulting Services Support You in Establishing the Appropriate Protocol to Support Your Business Objectives
Regulatory & Compliance Consulting Services
Precision Environment’s Regulatory and Compliance Consulting services ensure that your cleanroom — cleanroom design and layout, equipment and materials, personnel, and material flow — is built to your industry’s specifications and meets regulatory requirements.
CLEANROOM REGULATORY COMPLIANCE CONSULTING
Our subject matter experts are well versed in regulatory requirements for many specialty cleanrooms including those used in:
- mAb’s, rDNA & rRNA Development
- Vaccine Development
- Integrated Continuous Manufacturing
- ATMPs (Cell Therapies, Gene Therapies, & Tissue Engineering Therapies)
- Oral Solid Dosage (OSD) Processes
- Biological Manufacturing
- Biosafety Laboratories (BSL Level 1-4)
- Human Plasma Fractionation
- API Facilities
Our expert team will also provide compliance consulting services for the following cleanroom components:
- ISO Compliance
- cGMP Compliance
- USP Compliance
- BSL / ABSL Compliance
- Material Selection
- URS Development
- Process Equipment Selection
- Hazardous Materials Assessment
- Risk Mitigation
- Process Equipment Systems Planning and Integration
- FDA Approval
- IQ/OQ/PQ Process Validation