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About Cyclone pharmaceuticals Pvt. Ltd.

About Us

Cyclone Pharmaceuticals Pvt. Ltd. is one of India’s leading GMP, Regulatory Affairs, and Pharma Compliance consultancy firms, trusted globally for delivering expert guidance, world-class audits, and end-to-end technical documentation support. Backed by a team of seasoned GMP experts, regulatory specialists, validation professionals, and industry veterans, we help pharmaceutical manufacturers meet international cGMP, WHO GMP, EU GMP, US FDA, MHRA, TGA, PIC/S, and ISO standards with confidence. Our solutions are designed for pharma, biotech, API, formulation, vaccines, biologicals, nutraceuticals, and FMCG industries seeking robust compliance, operational excellence, and global market readiness.

What We Specialize In:

  • GMP Consultancy & Pharma Audits (WHO, EU, US FDA, MHRA, TGA, PIC/S)
  • Regulatory Affairs & Technical Documentation (CTD, eCTD, DMF, SOPs, QMS, Validation Docs)
  • GMP Training & Skill Development Programs
  • GxP Qualification & Validation Services
  • Pharma-IT Solutions & Digitalization Tools (PaperLess GMP)
  • QA/QC Improvement, CAPA, and Quality System Upgrades
  • Manufacturing Site Upgradation & Global Compliance Strategy

Our strength lies in providing client-centric, result-oriented, and audit-ready solutions that elevate compliance and drive long-term growth.

About Cyclone Pharmaceuticals

Driving Innovation Through PaperLess GMP

Innovation is at the heart of Cyclone Pharmaceuticals. Our advanced digital ecosystem, PaperLess GMP, is built to revolutionize how pharmaceutical companies manage GMP documentation, QMS processes, training records, audits, validation files, and regulatory submissions.

Designed to meet global pharmaceutical compliance requirements, PaperLess GMP enables companies to achieve 100% data integrity, streamlined documentation, and real-time operational visibility.

  • Digital GMP Documentation (SOPs, BMR, BPR, Policies, Logs)
  • Electronic Document Management System (eDMS) for Pharma
  • QMS Software for Pharmaceutical Industry (Deviation, Change Control, CAPA)
  • Audit Management, Training Management & Vendor Qualification
  • Pharmaceutical ERP & Batch Management Capabilities
  • 21 CFR Part 11 & Data Integrity Compliant Workflows

PaperLess GMP helps modernize operations, enhance compliance, and accelerate digital transformation across pharma, biotech, API, and nutraceutical companies.

Why Global Pharma Companies Trust Us

Pharmaceutical companies across India, Asia, Middle East, Europe, and Africa trust Cyclone Pharmaceuticals Pvt. Ltd. for our unmatched expertise in GMP consultancy, regulatory affairs, pharmaceutical compliance consulting, validation, and global audit readiness. We deliver high-quality solutions rooted in precision, integrity, and proven industry frameworks.

  • Client-centric approach with measurable compliance outcomes
  • Strict adherence to GMP, cGMP, WHO, US FDA, EU, MHRA, and TGA regulatory expectations
  • Transparent, ethical, and audit-ready consulting processes
  • Cost-effective pharma consulting without compromising global quality standards
  • End-to-end support for regulatory submissions, documentation, and compliance strategy
  • Decades of expertise from India’s best GMP, QA, and Regulatory Affairs specialists

Our goal is to empower companies with high-quality systems, regulatory confidence, and long-term operational excellence.

Why Pharma Companies Trust Cyclone Pharmaceuticals

Our Legacy of Empowering the Pharma Industry

Over the years, Cyclone Pharmaceuticals Pvt. Ltd. has built a strong legacy of supporting pharmaceutical manufacturers of all sizes—from MSMEs to global corporations— in achieving GMP compliance, regulatory success, operational efficiency, and audit preparedness.

Our work spans across formulation, API, biologicals, vaccines, injectables, medical devices, cosmetics, and nutraceutical sectors, consistently helping companies meet international regulatory expectations through our expert guidance and structured methodologies.

  • Upgrading plants to WHO GMP, EU GMP, US FDA & MHRA standards
  • Developing complete CTD/eCTD dossiers, DMFs & regulatory documentation
  • Executing large-scale validation, qualification & compliance projects
  • Providing expert GMP, QA, QC, and regulatory training for pharma teams
  • Consulting for product registration, regulatory submissions & global approvals
  • Helping teams strengthen quality culture, systems, and operational capability

With continuous innovation, dedication, and excellence, we are committed to shaping the future of global pharmaceutical compliance.

Regulatory Compliance | Technical Documentation | GMP Training | Pharma Consultancy

Cyclone Pharmaceuticals Pvt. Ltd. is widely recognized as India's leading company in the fields of GMP, Regulatory, and Pharma-IT. Our organization is dedicated to assisting the pharmaceutical industry in elevating their manufacturing capabilities and ensuring compliance with the current global cGMP regulations.

Throughout our journey, we have achieved numerous milestones and have consistently aided our clients in their progress and growth through the introduction of innovative ideas and concepts. With our expertise, we have successfully helped hundreds of small-scale manufacturers in upgrading their systems. Furthermore, we have recently developed an advanced software called PaperLess GMP, which revolutionizes the concept of digitalization in the pharma industry and is poised to shape the future of this field.

At Cyclone Pharmaceuticals Pvt. Ltd., our core values are reflected in our commitment towards delivering cost-effective solutions, maintaining the highest quality standards, and upholding a strong sense of dedication.

Sachin Bhalekar
Director and Chief Consultant, CPPL
Best Reason

Why Choose Us

To provide clients with affordable and useful solutions to aid in their compliance process, and to educate the pharmaceutical business about current legislation and industrial practices in GMP and regulatory.
To introduce innovation and fresh ideas to pharmaceutical consulting services Create documentation and systems of industrial quality. Paperless Our breath is SAVE COST | SAVE ENVIRONMENT.
Targeted At demonstrating that we are the world's top pharmaceutical consultant by upholding the greatest moral and ethical standards in business Our greatest asset is our satisfied clients.
GMP
200%
Regulatory
85%
Trainings
95%
Digitalisation and New Concepts
75%

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