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Strategic Documentation & Regulatory Support for Medical Device Companies

Decades of experience

Why Choose Panacea Medical Consultants?

  • Industry Expertise: Years of hands-on experience in global medical device regulatory frameworks.

  • Precision & Quality: Every document is accurate, comprehensive, and regulator-ready.

  • End-to-End Support: From strategy to writing to submission—we’re your extended regulatory team.

  • Global Reach: With offices in India and the US, we serve clients across North America, Europe, and Asia.

Services

Medical Writing Services

Clinical Evaluation Reports (CER)

“State of the Art Reports”, Risk Management, Harms evaluation

Post-Treatment Care

Clearly structured documents following ICH E6 and E3 guidelines for effective trial design and reporting.

Lay Summaries

Non-technical summaries for patient transparency, aligned with EU Regulation (EU) 536/2014.

Services

Quality System Documentation

  • SOP Development – Tailored Standard Operating Procedures to match your internal processes and regulatory expectations.
  • Risk Management Files – Comprehensive documentation under ISO 14971 including risk analysis, evaluation, and control measures.
  • QMS Documentation – Creation and refinement of quality manuals, records, policies, and templates.
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Services

Common Technical Document (CTD) Preparation

For combination products and drug-device interfaces, we help prepare CTD Modules (especially 2.5, 2.7, and 5), ensuring alignment with FDA and EMA standards.

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Services

Post-Market Documentation Support

  • Post-Market Surveillance (PMS) Reports
  • Periodic Safety Update Reports (PSUR)
  • Summary of Safety and Clinical Performance (SSCP)
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Regulatory Consulting

We guide you through complex global regulatory pathways with strategic insights and documentation that drives approvals.

Submissions (FDA)

Full preparation and submission support for Class II devices seeking US.

Technical File & Design Dossier

Structured documentation for CE Marking under EU MDR/IVDR.

Investigational New Drug (IND)

IND support including study designs, safety data, and regulatory communication.

Paediatric Study Plan (PSP)

Pediatric development documentation for FDA and EMA compli

Authority Responses

Timely, strategic replies to regulator queries that prevent delays in approval.

At PM Consultants we are a group of dedicated medical writers, regulatory affairs professionals, clinical researchers, and quality

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