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Anacon Research Pvt. Ltd. is a trusted regulatory consulting partner providing strategic, scientific, and compliance-driven solutions to pharmaceutical, biotechnology, and medical device companies worldwide. Our experienced regulatory professionals support clients throughout the entire product lifecycle—from early development and regulatory planning to market authorization, lifecycle management, and post-market compliance.

With in-depth knowledge of international regulatory frameworks, we help organizations accelerate product approvals, mitigate regulatory risks, and achieve successful market access across global jurisdictions.

Regulatory Consulting for Niche Pharmaceutical Products

We provide specialized regulatory support for complex and innovative pharmaceutical products, including Oncology Products, Orphan Drugs, Simple & Complex Generics, Specialty and Innovative Drug Products.

Our Capabilities:

  • Global Regulatory Strategy Development
  • Regulatory Intelligence & Gap Assessment
  • Product Development Regulatory Roadmaps
  • Scientific Advice & Regulatory Pathway Planning
  • Dossier Authoring & Scientific Writing
  • CTD/eCTD Dossier Compilation and Publishing
  • Module 2–5 Documentation Support
  • CMC Regulatory Documentation Authoring & Review
  • Clinical and Non-Clinical Regulatory Consulting
  • Health Authority Query Response Management
  • Regulatory Submission Support
  • Lifecycle Management, Variations and Renewals
  • Regulatory Due Diligence and Compliance Reviews

Medical Device Regulatory Consulting

We provide comprehensive regulatory solutions for manufacturers of medical devices and in vitro diagnostic (IVD) devices, ensuring compliance with evolving international regulations while facilitating efficient global market access.

Areas of Expertise: Substance Based Medical Devices (SbMD), In Vitro Diagnostic (IVD) Devices, Combination Products, Implantable Devices, Software as a Medical Device (SaMD).

Our Services:

  • Global Regulatory Strategy
  • Device Classification & Regulatory Pathway Assessment
  • Technical Documentation Authoring
  • Technical File & Design Dossier Compilation
  • Clinical Evaluation Report (CER) Preparation
  • Performance Evaluation Report (PER)
  • Risk Management Documentation (ISO 14971)
  • Usability Engineering Documentation (IEC 62366)
  • ISO 13485 Quality Management System Consulting
  • UDI Strategy & Labeling Compliance
  • Post-Market Surveillance (PMS)
  • Post-Market Clinical Follow-up (PMCF)
  • Vigilance & Regulatory Compliance Support
  • Regulatory Audit Readiness
  • Notified Body & Regulatory Inspection Support

Dossier Authoring & Regulatory Documentation

High-quality regulatory documentation is fundamental to successful submissions. Our scientific writing and regulatory documentation specialists prepare clear, compliant, and technically robust dossiers that meet the expectations of global health authorities.

Our documentation services include:

  • CTD & eCTD Authoring
  • Technical File Preparation
  • Design Dossier Compilation
  • Common Submission Dossier Preparation
  • Clinical Evaluation Reports (CER)
  • Performance Evaluation Reports (PER)
  • Investigator's Brochure (IB)
  • Clinical Study Protocols
  • Clinical Study Reports (CSR)
  • Risk Management Files
  • Standard Operating Procedures (SOPs)
  • Regulatory Gap Assessments
  • Deficiency Response Documents
  • CMC Dossier authoring and compilation including PDR development
  • Authoring and compilation of Clinical and Non- Clinical summaries and overviews

Why International Clients Choose Anacon Research

  • Experienced multidisciplinary regulatory professionals
  • End-to-end regulatory consulting under one roof
  • Expertise across pharmaceuticals, biologics and medical devices
  • Strong scientific writing and dossier authoring capabilities
  • Global regulatory knowledge and market access strategies
  • Practical, risk-based regulatory solutions
  • Timely project execution with transparent communication
  • Commitment to quality, compliance, and client success

Global Regulatory Expertise

Our consultants support product registrations and regulatory compliance across major international markets, including:

  • US FDA
  • EU MDR / IVDR
  • UKCA
  • CDSCO (India)
  • Health Canada
  • TGA (Australia)
  • GCC Countries
  • ASEAN Region
  • Latin America
  • Africa & Emerging

Our Commitment

At Anacon Research, we believe regulatory excellence is more than achieving approvals—it is about building sustainable compliance strategies that support innovation and long-term commercial success. By combining scientific expertise, regulatory insight, and global experience, we help our clients confidently navigate complex regulatory environments and bring safe, effective, and high-quality healthcare products to patients worldwide.

Partner with Anacon Research Pvt. Ltd. to transform regulatory challenges into opportunities for global growth.

Schedule a Consultation to Learn How We Can Help!

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