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Anacon Research provides comprehensive Good Manufacturing Practice (GMP) Consulting and Audit Services to pharmaceutical, biotechnology, medical device, API, and healthcare companies, helping them achieve and maintain compliance with global regulatory requirements. Our team of experienced GMP auditors and regulatory experts supports organizations in strengthening quality systems, ensuring inspection readiness, and minimizing compliance risks.

Our GMP consulting services cover the design, implementation, and optimization of Pharmaceutical Quality Systems (PQS), SOP development, data integrity compliance, risk management, validation strategies, CAPA management, quality risk assessments, and regulatory inspection preparedness. We assist clients in aligning their manufacturing operations with international GMP standards, including WHO-GMP, EU-GMP, US FDA, PIC/S, MHRA, TGA, and other global regulatory expectations.

Our independent GMP audit services include:

  • Supplier Qualification Audits
  • API Manufacturing Facility Audits
  • Finished Dosage Manufacturing Audits
  • Contract Manufacturing Organization (CMO/CDMO) Audits
  • Excipient and Raw Material Supplier Audits
  • Quality System Audits
  • Data Integrity Audits
  • Laboratory Compliance Audits
  • Warehouse & Distribution (GDP) Audits
  • Gap Analysis & Regulatory Readiness Audits
  • Pre-Regulatory Inspection Audits (Mock FDA, EMA, MHRA, WHO Inspections)
  • Due Diligence Audits for Mergers, Acquisitions, and Technology Transfers

Scope of Assessment:

  • Quality Management System
  • Personnel & Training
  • Facility Design & Maintenance
  • Equipment Qualification & Calibration
  • Production & Process Controls
  • Documentation & Record Management
  • Validation & Qualification Programs
  • Laboratory Controls
  • Data Integrity & Computerized Systems
  • Deviation, CAPA & Change Control Systems
  • Complaint Handling & Product Recall
  • Self-Inspection & Continuous Improvement

Our Deliverables:

  • Detailed Audit Report with Risk Classification
  • Critical, Major & Minor Observations
  • Regulatory Compliance Gap Assessment
  • Corrective and Preventive Action (CAPA) Recommendations
  • Executive Summary for Management Review
  • Follow-up Audit Support (Optional)

Each audit is conducted using internationally accepted methodologies and detailed checklists to identify compliance gaps, assess risks, and provide practical, business-focused recommendations. Following every audit, clients receive comprehensive audit reports with risk-based observations, root cause analysis, and actionable CAPA recommendations to support continuous quality improvement.

Why Choose Anacon Research?

  • Experienced GMP auditors with global regulatory expertise
  • Independent, confidential, and risk-based assessments
  • Audits aligned with international regulatory expectations
  • Practical recommendations focused on compliance and operational excellence
  • Flexible on-site, remote, and hybrid audit solutions
  • Support for regulatory inspections and continuous quality improvement

At Anacon Research Pvt. Ltd., we help organizations strengthen their quality systems, ensure regulatory compliance, minimize business risks, and build confidence across the pharmaceutical and healthcare supply chain through professional GMP audit services.

With extensive global experience, Anacon Research helps organizations build sustainable quality systems, enhance operational excellence, ensure regulatory compliance, and confidently face health authority inspections.

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