Safe Equipment and Systems
- The selection and characterisation of construction materials
- A risk analysis in accordance with European and US Pharmacopeia standards
- Extractables testing strategies
- A review of protocol and monitoring of extractable studies
- A toxicological risk assessment of results
Why choose us?
SAXOCON services for the manufacture of pharmaceutical products give you access to:
- A multidisciplinary team of highly skilled toxicologists, material scientists, and supply chain professionals
- Extensive experience in pharmaceutical product safety assessment
- Safety evaluations based on proprietary information obtained from our worldwide network of materials suppliers
- State-of-the-art solutions according to international standards and regulatory guidelines
- Smart, cost-effective test strategies that bring your products to market in a timely manner
SAXOCON compiles all necessary documentation for you to receive a Good Manufacturing Practice file as a written report.
EMA nitrosamine requirements.
Particulate matter screening.
Maintain GMP in relation to ICH Q7-9
Establish PDE for production.