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Quality
Management

Ensuring strict compliance, through risk-based QMS systems & processes 

 

 

Exceeding Quality Standards  

Striving to exceed all quality related expectations, ensuring only the highest degree of service is provided to our customers.

SanaClis has successfully executed various clinical studies (innovative, biologics, biosimilars and generics) including proof of concept and medical device projects for us customers worldwide.

Our Quality Management services include:

  • Consultancy and advise on quality matters and compliance
  • Audits of clinical sites
  • Audits of clinical trial vendors
  • Audits of manufacturing sites
  • Creation of Standard Operating Procedures (SOP's) for clinical operations, supply chain and sourcing
  • Support of project-specific activities 

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25+

years experience across all phases & indications

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220+

external audits and inspections, no critical findings

Standard Operating Procedures

SanaClis has a thorough collection of comprehensive SOPs to ensure all employees and staff achieve efficiency, maintain quality output and consistent performance. This in turn eliminates the possibility of miscommunication and failure to comply with industry regulations. All activities are performed in strict compliance with applicable procedures.

In addition, all SOP's are carefully reviewed on regular basis to ensure their systematic suitability and are revised as required internally and by the sponsor.

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