Services for API Manufacturers
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Our expert auditors help you to ensure that you comply with international regulations and standards and stringent market requirements recognised in the pharmaceutical industry, such as EU GMP part 2 / ICH Q7.
Eurofins Healthcare Assurance supports APIs Manufacturers with dedicated services:
- Gap analysis to prepare National Health Agencies inspections (EU, US, UK, Japan, Australia…)
- Audit of your Contract Manufacturers,
- Audit of your supply chain, thanks to our long experience in Starting Materials audits,
- Mapping of your supply chain to increase your control on it and mitigate associated risks,
- Building of your risk analysis to prioritize your auditing programme,
- Optimise your budget thanks to:
- a shared audit proposition,
- a network of qualified auditors, located in the main manufacturing countries to reduce travel fees and increase reactivity
- Training of your employees to applicable GMPs (EU GMP part 2, ICHQ7, EU GDP…). On-site and remote training.
Healthcare Assurance
Identify and mitigate risks in the entire supply chain
