Preparation and submission of audit compliance reports for regulatory agencies like MHRA, USFDA, TGA, MCC, AFSSAPS & WHO, by establishing the following:

• SYSTEMS assessment
• Evaluate appropriate written procedures and adherence.
• Additional systems to be inspected.
• Drill down technique used
• Ensure effective systems to avoid insignificant failures
• Ensure effective systems to avoid significant failures

Salient Features

• Evaluate if QA unit has reviewed and approved all procedures related to production, QC and QA.
• To assure the procedures are adequate for their intended use (including associated record keeping systems).
• To assess the data collected to identify quality problems (may link to other major systems)
• To assure compliances with
  • Submission commitment.
  • Good Manufacturing Practices.

Mode of Services

Services A

• Meeting with client.
• Make a gap and risk analysis assessment, Reconciliation of all discrepancies.
• Define CAPA and make sure it’s implementation.
• Regular visits to discover the issues that can be and very often are damaging to individual company.

Services B

• Meeting with client.
• Identify and
• Make a gap and risk analysis assessment, Reconciliation of all discrepancies.
• Appoint fulltime Sasaglobal team at the site for agreed period and our team implement all the defined action plan.
• Execution of this service gives tremendous reassurance to get through audit by concerned regulatory agency.
• Regular visits to discover the issues that can be and very often are damaging to individual company.
• Training & development by our seniors to client’s staff.