Regulatory Compliance

"I was impressed with the dedication of the Magellan team in the development of a publication review and abstracting of the data we use for product development. The design of the database for current and future queries was really done well, plus the project was completed early and on budget."

Sr. Director – Research & Development and Clinical Affairs - Davol

Connecting Knowledge to Needs - Helping You Perform Better

Strategy

  • Regulatory Strategy
  • Compliance Assessment
  • Gap Analysis
  • Post-Market Support
  • Quality Systems

Implementation

  • 510(k) Submissions
  • Clinical Evaluation Reports (CER)
  • Auditing QSR/GMP/GCP/GTP/21 CFR
  • Training
  • SOP guidance
  • Medical writing

Consulting Differently

If there is something about the words regulatory and compliance that starts to make you nervous, you have navigated to the right place. The future of your company is riding on complying with the regulations and doing it right the first time. At Magellan we think differently, and we consult differently too. For each project, we take a step back, help you analyze the situation and develop a logical, sound go forward plan. Except we don’t stop there, giving you a high level strategy, which leaves you with even more work to do and no one but your limited team to figure out how and when to do. The Magellan team will work with you side by side, complimenting your resources to accomplish a task which when completed properly will ultimately positively impact your business, the future of medicine and the patients you are so valiantly trying to help.

Regulatory Compliance Teams

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

Directors, Managers, Coordinators, Analysts, and Associates 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 - Sales Associates, Sales Support, Recall Specialists, On-site Specialists, Reimbursement Specialists, Clinical Monitors, 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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