Quality Systems:
- GxP (GMP, GLP, GCP), GAMP, and QSR regulation consultation, strategy and gap analyses
- Development of customized Corporate Quality Systems Master Plans, including integration with any client desired elements related to universal quality enhancement principles such as
- Quality and Technology Integration planning focusing on the technology platform(s) and quality/compliance goals of the individual client
- Compliance Enhancement Programs for drugs, biologics, devices, and combination products
- CAPA System development and/or tracking execution
Quality Assurance:
- Planning and execution of Quality Assurance Review projects such as
- Contract Manufacturer or internal batch records (including manufacturing, testing and labeling/packaging), validation protocols/ reports and GxP development reports
- Standard Operating Procedure (SOP) and Change Control system development and implementation
- Master Documentation development for manufacturing and testing
- SOP writing
- Training program development and providing on-site or distance training courses
- training system and information tracking
Quality Control:
- Implementation and evaluation Quality Control (laboratory) systems
- Identification, set-up and/or management of Contract Laboratories (GxP)
- Development, evaluation and/or execution of Stability programs
- Validation services for methods and equipment
- Product trouble-shooting and investigation
Quality Management:
- Supplier Quality Agreement negotiation on behalf of clients
- Quality Project Management of GxP Contract Service Providers to meet client requirements
- Technical writing and/or review for communications with regulatory agencies, including INDs, NDAs, BLAs, DMFs, and annual reports
Quality/compliance:
- Internal and external Supplier Audits according to US and EU regulatory requirements and/or unique client requirements
- Remediation Programs (e.g. for required actions related to FDA Form 483, warning letters and consent decrees)
- Mock inspections including the use of team-based approaches with technical specialists to cover the area(s) of interest to the client
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