Harris Group Inc.
Regulatory Compliance
Harris Group has developed a professional staff with an extensive knowledge of regulatory requirements. Our in-house cGMP expertise ensures that your project will meet or exceed all applicable regulatory requirements for process validation including production equipment, piping design and layout, materials construction, movement of materials and personnel, control of environmental conditions, clean in-place and sanitation systems, and critical utilities such as purified water, clean steam, and air. We also support our customers with assistance in quality assurance programs and documentation in support of FDA and EU submissions.Most popular related searches
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Regulatory Compliance capabilities include:
- FDA and EU Documentation for Drug and Device Manufacturing
- Chemistry, Manufacturing and Controls (CMC)
- Drug/Device Master File (DMF)
- Investigational Medicinal Product Dossier (IMPD)
- Investigational New Drug/Device (IND)
- New Drug and Biologic License Application (NDA, BLA)
- Facility Layouts, Process Flow Diagrams and Area Classifications
- Cleanroom Facility Qualifications
- Environmental Monitoring Programs
- Aseptic Filling Validation
- Risk Based Verification, Qualification and Validation Master Plans
- ASTM E-2500 Training and Implementation
- GAMP 5, Computer Systems Validation (CSV)
- FDA Draft Guidance: Process Design, Qualification and Validation
- Corrective Action/Preventive Action (CAPA)
- Risk Analysis
- Materials Review Board (MRB)
- CMO Reviews and Audits
- Quality Systems GAP Analysis and Remediation
- GMP Audits
- Annual Audits
- Mock FDA Pre Approval Inspection (PAI) Audits
- Vendor/CMO Audits
- CAPA
- E 2500