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Regulatory Resources

US FDA

Medical Device Resources:

Drug resources:

International

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Services

We provide regulatory, quality, and clinical services to medical device and pharmaceutical companies during all stages of product development.

We assist with products in all three medical device classes, including software products, active implantable devices, combination products as well as pharmaceutical products. Our experience is in the areas of Cardiovascular, ENT, Respiratory, Urology, Nephrology, OBGYN, Neurology, Orthopedics, Gastroenterology, and Metabolic Diseases.

Product Development Request Proposal

Regulatory Resources

Regulatory

  • Regulatory Intelligence
  • Due Diligence
  • Communications with Agencies
  • Digital Health/Mobile Technology Assessment
  • Worldwide Regulatory Strategies
  • Submission Planning & Management
  • Submission Templates
  • Submissions for Medical Devices: Pre-subs, IDEs, 510(k)s, PMAs, HDEs, Request for Designation, de novos, technical files and design dossiers
  • Submissions for Pharmaceuticals: Pre-INDs, INDs, request for orphan-drug designation

Clinical

  • GCP Compliance – ISO and ICH
  • Clinical Protocols and Reports
  • Literature Search Reports
  • IRB/EC Submissions
  • Investigational Brochures
  • Case Report Forms
  • Clinical Study Management in Eastern Europe
  • Clinical Trial Management

Quality

  • Quality Systems and GMP Compliance; ISO and ICH
  • Operating Procedures
  • Risk Analyses and Risk Mitigation
  • Document Control
  • Internal and Supplier Audits
  • Case Report Forms
  • Support with UDI requirements
  • Part 4 Combination Products GMP Compliance

Project Management

  • Non−Clinical Testing - biocompatibility and animal models
  • Design Control
  • Supplier Negotiations
  • Talent Acquisition