What We're Offering

USFDA

MFDS (KOREAN FDA)

COFEPRIS

HEALTH CANADA

About Us

About Us

Incorporated in June 2002.

A leading provider of Quality, Regulatory and Project consultancy services for compliance to USFDA, EDQM, EU GMP, MHRA, TGA, MCC, MFDS (KOREAN FDA), COFEPRIS, HEALTH CANADA. PMDA and other regulatory agencies for API, BIOTECHNOLOGY and FORMULATIONS manufacturing pharmaceutical companies.

Why Choose Us

We have an enviable track record of more than 135 successful USFDA/EDQM/COFEPRIS /MFDS (KFDA)/Health Canada and other International Regulatory Inspections/approvals & Greenfield and upgradation projects.

  • > 250 DMF
  • >100 CEPs granted
  • 144 International Inspections that includes
  • 73 US FDA inspections
  • >30 EDQM/EUGMP
  • 40 OTHERS(COFEPRIS , ANVISA , PMDA , MFDS, etc. )
  • 20 Projects ( Green Field & Turnkey )
Know More

Services

Outsourcing Consultancy / Business Development

Virtual Audits – New Normal (Covid-19)

Third Party Audits

Specialized Services

Training

Project

Approvals / Inspections

Quality Management

Why Choose Us?

We have an enviable track record of more than 135 successful USFDA/EDQM/COFEPRIS /MFDS (KFDA)/Health Canada and other International Regulatory Inspections/approvals & Greenfield and upgradation projects.

  • > 250 DMF
  • >100 CEPs granted
  • 144 International Inspections that includes
  • 73 US FDA inspections
  • >30 EDQM/EUGMP
  • 40 OTHERS(COFEPRIS , ANVISA , PMDA , MFDS, etc. )
  • 20 Projects ( Green Field & Turnkey )

Latest Blogs

22 May, 2026

What Are the Common Reasons for USFDA 483 Observations?
22 May, 2026

What Is Quality Management Consulting in Pharmaceuticals?
22 May, 2026

What Is GMP Consultancy and Why Is It Important?

Frequently Asked Questions

Many companies struggle to identify compliance gaps before an inspection. Working with an FDA Inspection Readiness Services in India provider helps uncover risks early and improves inspection confidence.

Audit observations need quick and effective action to avoid future issues. Pharma Audit Response Consulting in India helps companies address findings, strengthen systems, and prevent repeat concerns.

Meeting international standards requires strong quality systems and proper documentation. USFDA Consultants for Pharma in India help API manufacturers align operations with current regulatory requirements.

Many compliance issues remain hidden until an inspection begins. Pre Inspection GAP Analysis in India helps identify weaknesses early, giving companies time to correct them before auditors arrive.

DMF preparation involves detailed technical and regulatory documents. Drug Master File Consulting in India helps companies organise submissions correctly and reduce delays during the review process.

Strong quality systems help maintain compliance, product consistency, and patient safety. Quality Management Services For Pharma Companies in India support continuous improvement and sustainable regulatory performance.