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Regulatory Affairs | Technical Services | Pharmacovigilance
PharmaServ offers a various mission-critical services to the regulated industry. Our scientific, technical and compliance experts are veterans of the Industry, and are capable of assisting you to resolve your most challenging issues. Our proficiency is based on the optimal integration of scientific, technical and regulatory principles. We work with our clients to design and implement effective and efficient processes that assure continued compliance. We help our clients stay current with the ever-changing regulatory environment. Our regulatory compliance services include the following:
Quality Systems Design and Evaluation
- Quality by Design
- Risk Assessment and Risk Management
- Quality Unit Roles and Responsibilities
- Facilities & Equipment Systems
- Materials Systems
- Production Systems
- Packaging & Labeling Systems
- Laboratory Controls Systems
Audits
- Regulatory Audits
- Vendor Qualification
- Documentation Audits including application integrity audits
- Adverse Drug Events system audits
- Verification of Regulatory Commitments
- Assessment of Annual Review Program
Compliance Assessment and Problem Resolution
- FDA 483 Inspection Responses
- FDA Warning Letter Responses
- Meetings with FDA, other Regulatory Bodies and Firms to Resolve Disputes
- Corrective and Preventive Action Programs ("CAPA")
- Third Party Expert Roles under Consent Decrees
Training Programs
- Regulatory Requirements and Compliance Trends
- Inspection Programs
- Enforcement Processes
- GMP, GCP and GLP
- Quality Systems
Regulatory Affairs | Scientific Affairs | Business Development
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