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QP
Services

Our dedicated in-house team of Qualified Persons is a guarantee that your IMP meets all applicable GMP standards, requirements and quality.

Unparalleled Service Offering 

QP services play a key role in bringing new products to market within the European Union and global clients can fully rely on our highly experienced teams to ensure their clinical studies meet the required standards efficiently, cost effectively and on schedule.

Our QP services include:

  • Upfront consultancy and advice
  • QP audit of the supply chain
  • QP declaration
  • QP Certification
  • Batch Release
  • UK QP oversight process (import from the EU from 1. Jan. 2022)

EU/ UK Qualified Person Services

Our in-house Qualified Persons (QP) team assumes responsibility for all stages of the drug process, including the audit of the supply chain for GMP compliance and oversees the completion of all batch documentation, clinical labelling / packaging, storage, and distribution complete with QP release.

In addition, SanaClis supports our customers needs with expert guidance on navigating the complexities of EU-UK QP release Post-Brexit.

 

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SanaClis Partners with Protara Therapeutics to Maintain Uninterrupted Clinical Supply

By collaborating with SanaClis, Protara has been able to expedite timelines and maintain reliable and uninterrupted clinical supply and saw meaningful improvements in study activities after only 2 months of partnership. SanaClis was able to execute multiple QP audits and issued QP declaration, which helped enable Protara to conduct a clinical trial at sites in the European Union.

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