We are team of experts in the quality and regulatory aspects of APIs and pharmaceutical products with experience in direct handling of

• Operational aspects of GMP manufacturing facilities.
• Regulatory requirements of GMP facilities
• Complete documentation requirements for the operation and facilities.
• Regulatory inspections for worldwide regulatory bodies.
• Remediation action arising out of the adverse inspection outcomes from the regulatory bodies
• Complete regulatory aspects for the DMF & ANDA filings, addressing regulatory follow up queries till approval of products from the regulatory bodies wordwide.
• Conducting facility audits.