Services
Regulatory/CMC * Clinical * Quality & Compliance * Operations * Validation
Results-oriented boutique consulting firm specializing in biopharmaceutical, pharmaceutical, cell/gene, medical device, food, medical cannabis, and natural health products & therapeutics.
Highly skilled in regulatory, clinical, quality, compliance, manufacturing operations management. Product and process development, scale up, validation, manufacturing and commercialization of large and small volume parenterals. Biologics, blood-derived therapeutics, and active pharmaceutical ingredients, (API's), as well as compounding pharmacy operations.
A team of experts in quality management, GMP, GLP, GCP, GPP, MDSAP regulatory compliance, manufacturing operations, capital projects, and regulatory affairs. Providing consulting services based on in-depth experience, knowledge, and through understanding of ICH, FDA, Health Canada, European, Australian, Japanese, as well as Korean Regulatory Agency requirements and guidelines.
Expertise
- Quality management and compliance services
- Operations, validation, audit and regulatory support services
- Quality risk management
- Clinical trial support services
- Medical device and diagnostics consulting services
- product life cycle support
- Training and development
- Backlog remediation
Process Engineering and Project Management - Development and Design Solutions
- Biopharmaceutical and GMP compliant facility master planning
- Process design, project development, and equipment integration
- Integrated modular facility design
- Biotechnology and vaccine manufacturing
- Plasma derived protein manufacturing
- Active pharmaceutical ingredient manufacturing
- Aseptic processing and fill/finish
- Oral solid dose manufacturing
- Consumer products and consumer health products
Services
Filter Performance and Analysis
- Filterability testing
- Filter compatibility screening
- Extractables testing and analysis
- Laser particle testing (particle retention efficiency)
- Qualititative and quantitative chemical analysis
- Filter quality certification program
- Filtration process reviews
Validation
- Microbiological services
- Microbial retention studies
- Compatibility screening
- Extractables testing
- Product based integrity testing
- Additional GMP documentation
Facility Tours and Audits
- Formal audits welcomed by current and potential customers
- Manufacturing, laboratory and quality operations inspections
SEM / X-Ray Analysis
- Scanning Electron Microscope and X-Ray analysis
- Low vacuum imaging
Training / Support
- Installation assistance
- CIP / SIP procedures, documentation and training
- Integrity testing training and certification program
- Training presentations