Quality
Complete Quality Management System (QMS) support including:
- Gap Analysis
- Quality Management Systems Build and Implementation
- Internal Audits / Supplier Audits / Mock Audits
- Design Controls / Design History File
- Aseptic Processing and Cleanrooms
- Product Development Reports
- Reliability / Human Factors
- Software Lifecycle Development
- Risk Management
- Complaint Handling
- CAPA processes
- Management Reviews
- ISO 13485, ISO 9001, ISO 14971, IEC 62304, ICH Q7-10, 21 CFR 820, 21 CFR 210/211, 21 CFR 809
Chemistry, Manufacturing and Controls (CMC)
Full support of CMC processes for drugs, biologics and in vitro diagnostics including:
- Aseptic processes / Cleanrooms
- Test methods and QC testing
- Preformulation and formulation development
- Stability
Regulatory
Regulatory services for various regions and countries including:
- 510k / PMA / NDA / BLA
- IDE / IND / Updates
- FDA Pre-NDA / Pre-Submission
- eCDT
- FDA 483 / Warning Letters Remediations
- EU Technical Documentation / Clinical Evaluation Report (CER)
- Production / Environments
- Quality Management System Documentation
cGxP
Regulatory services for various regions and countries including:
- Pre-Clinical / Clinical / Early Commercial
- Validation IQ / OQ / PQ
- Software Lifecycle Development and Validation
- Process Flow / Optimization
- QC GLP Test and Release
- Peptides / Small Molecules / Biologics
- Medical Devices / Combination Products / In Vitro Diagnostics (IVDs)
- Cellular and Tissue products (HCT/P)