Quality Assurance services

End-to-end Quality Assurance support to companies throughout the development phase, strategy to the execution, by advice, management, writing, reviewing and implementation of quality policy, quality systems and quality documents and verification of their effectiveness and compliance.

TheRAssist supports the whole spectrum of bio-pharmaceutical companies, from early stages startups to well-established commercial companies. 

 

Including:

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• Establishment and implementation of GMP and GCP quality assurance systems including change control, documentation control, investigation of deviations and out of specifications and effective CAPA system, vendor qualification audits and vendor quality oversight, batch record review and batch release, risk management, complaints reporting system and training 

  • Writing and reviewing SOPs

  • Training 

  • Implementation and verification
     

• Suppliers/vendors qualifications

  • Audits

  • Review of Quality Agreements
     

• Support in quality investigations

  • Deviations 

  • Out of specifications

  • Complaints
     

• Release of drug product batches

• Preparation for audits and regulatory inspections