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Method?Validation Services
FromRecipharm AB
We provide analytical validation in compliance with the European Pharmacopoeia (Ph. Eur) the US Food and Drug Administration (US FDA), current Good Manufacturing Practices (cGMP) and International Council for Harmonisation (ICH) requirements.
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Our method validation service includes:
- Method validation executed as per the current regulatory and ICH guidelines in adherence to cGMP
- Protocols prepared by Recipharm?or validation executed as per sponsor’s approved protocols
- Custom-field calculations, e-sign off procedures
- Meeting stringent timelines through collaborative effort with customers