Staff Augmentation Services - Regulatory
Pharma-Tech Process and Facilities Services, LLC provides technical support and quality engineering services in support of virtually all aspects of biopharmaceutical manufacturing operations. Our project management and technical service personnel can identify efficiencies and strategies to streamline regulatory compliance with thorough understanding regulatory compliance requirements and best practices with a deep cross-functional understanding of complex biopharmaceutical manufacturing operations and quality systems.
Pharma-Tech Regulatory capabilities include:
- Regulatory Engineering and Technology
- Regulatory Compliance Subject Matter Expertise
- Regulatory Project Management Best Practices
- Regulatory Best Practices
- Owners Representation and oversight
- Cross-Functional Communication
- Organizational Development
- Operational Excellence
- Information Technology
- Aseptic Processing
- Cell Culture and Upstream Processing
- Purification and Downstream Processing
- Formulation and Fill Finish
- Technical Writing
- Change Control and Management
- Special Projects
- Criticality and Impact Assessment
- Risk Assessment and Mitigation
- Pre-IND and IND Submissions
- NDA and BLA Submission
- FDA 483 and Warning Letter Remediation
- Integrated Regulatory Assurance Strategies
- Standard Operating Procedures (SOPs) and Guidelines
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