Regulatory Compliance

"Not only did Magellan do such a thorough gap analysis of our quality system, they provided our regulatory and quality systems team with the roadmap to addressing our deficiencies to help us ensure we are compliant, prior to the FDA’s audit.  They made some great catches as they critically reviewed more than 200 SOPs and even provided a solid, implementable recommendation on how to better organize the system which won’t require a great deal of work for us.”

VP of Regulatory - Biologic/Tissue Company

Connecting Knowledge to Needs - Helping You Perform Better

Strategy

  • Regulatory Strategy
  • Compliance Assessment
  • Gap Analysis
  • FDA Consulting
  • Post-market Support
  • Quality Systems

Implementation

  • 510(k) and PMA Submissions
  • Clinical Evaluation Reports (CER)
  • Auditing QSR/GMP/GCP/GTP/21 CFR
  • FDA Communication and Liason
  • Training
  • Standard Operating Procedures (SOP) and Guidance
  • Medical writing

Consulting Differently

The clock is ticking, deadlines are looming, and the regulatory body will be going over your paperwork with a fine-tooth comb.
Successfully navigating regulatory compliance is critical. The future of your company relies on getting it right the first time. One misstep can have expensive consequences down the road, costing you valuable time, delays launching innovative competitive products, money, and even possible damage your company’s reputation.
Magellan Medical Technology Consultants works side-by-side with your team to ensure that your regulatory submissions, Clinical Evaluation Reports (CERs), quality systems, SOPs, and reporting are buttoned up tight. Your Magellan team will provide a comprehensive structure and sequence grounded in experience and expertise to ensure every ‘t’ is crossed and ‘i’ is dotted. You’ll get a thorough analysis, a strategic plan to move forward and a Magellan team of experts to implement that plan, from pathway development through post-market compliance support.
We’re here to guide you through the full process. With Magellan’s thinkers and doers on your side, you can overcome regulatory and compliance hurdles more efficiently and successfully than ever, ensuring patients benefit from your life-altering technologies faster.

Regulatory Compliance Teams

Our Regulatory Compliance teams are comprised of seasoned professionals who have previously worked as:

Director of Regulatory Affairs, Regulatory Affairs Managers, Regulatory Compliance Specialists, Quality Systems Managers, Biostatisticians, to name a few.

Our Integrated Business Units

  • Marketing and Sales - Product Testing, Voice of the Customer/Patient/Payor, Pricing Sensitivity, Health Economics, Technical Writing, Consensus Summits, Creative Communication, read more
  • Clinical Research Organization - Study Design, Biostatistical Analysis, Phase I - IV, Post-market Studies, Registries, read more
  • National Field Teams - Clinical Specialists, Clinical Research Monitors, Sales Associates, Sales Support, Recall Specialists, On-site Specialists, Reimbursement Specialists, read more
  • Reimbursement Solutions - New Code, Appeals, Call Centers, Pre-authorization, Claims Processing, Denials, Improving Revenue Cycle, read more
  • Regulatory and Compliance - FDA and OUS Strategy, Assessment, Compliance, Post-market Support, Quality Systems, read more

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