Based on our extensive experience , knowledge and understanding of FDA, HC, EMA and ICH regulations and guidelines, we perform for our customers:
Quality
- Temporary replacement of a senior quality manager
- Implementation of a quality management system adapted to the size of your company
- Development, implementation and monitoring of the following Quality programs and processes:
- Training program
- Deviation program, change control and CAPAs
- Risk analysis program
- Risk-based supplier qualification program
- Environmental monitoring program
- Product stability program
- Quality process optimization
- Drafting of Quality Manuals/Site Master Documents and procedures
- Management of eQMS acquisition and implementation phases
- Selection and qualification of suppliers, CMO/TPLs
- QA review of protocols/validation reports/qualifications
- Operational design in compliance with regulatory requirements and start-up of QC laboratories
- Drafting and review of QC-analytical, bioanalytical and microbiological validation/transfer protocols
- Review of batch records
- Quality management system training such as BPx training (GMP, GCP, GDP, etc.)
- Coaching and Mentoring
Compliance
- FDA, HC and EMA regulatory inspections:
- GAP analysis against regulatory requirements
- Implementation of an inspection management system (preparation of rooms and communications systems, training, EMS coaching, etc.)
- Assist during inspections to prepare response strategies and coaching of SMEs
- Development of corrective plans required as a result of these inspections
- Support the preparation of responses to regulatory agencies
- Perform audits of suppliers, manufacturers, packagers, laboratories (GMP and GLP) and distributors.
- Perform audits of clinical sites (GCP)
- Support the conduct of major and critical investigations
- Perform site maturity analysis and CMC dossier for FDA, HC or EMA pre-licensing inspection of product, PLI or PAI