Quality Assurance

service-1

Our quality policy is to conduct business through self imposed Professional Ethics and Quality Management Systems. Synapse has more than 300 SOPs to regulate different research activities within the unit.
We have a successful track record of regulatory inspections/ audits by the USFDA, EMA, MHRA, TGA, DCGI, ANSM, BfArM. Our study data is a part of drug dossiers filed with various regulatory authorities in EU and US.

Our key strengths of QA:

  • Well structured QA audits at pre-defined intervals to ensure data integrity
  • Regular system audits to facilitate continuous system improvements/li>
  • Handle regulatory/sponsors queries, recommendations through corrective/preventive actions, modifying and implementing our systems and processes wherever required
  • Conduct internal audits of study activities and data/reports and ensuring compliance as indicated by acceptance of the product dossiers (Regulatory submissions) by regulatory agencies
  • Manage sponsor audits for assessment of Synapse facilities & GCP/GLP compliance
  • Dedicated, qualified & well trained QA auditors
  • Teams with well defined job responsibilities for conducting internal audits, document control and archival activities