REMS Group

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Benefits must outweigh risk...this is the cornerstone of patient safety.

Services

REMS Group is research-based consultancy and training institute committed to improving healthcare outcomes through advancement of REMS programs in the pharmaceutical, biotechnology, device and diagnostics industries.

We are experienced in designing and implementing REMS programs that are approved by the FDA and successfully implemented in the healthcare environment.

We meet with our clients to review their product attributes, design a REMS program that will meet the FDA’s high standards, and implement the REMS initiatives. Our focus on enterprise, sales rep training and vital communications helps to ensure timely, successful product launches and continuing marketing efforts.

Our services:

Whether you anticipate REMS requirements during your NDA, post-marketing efforts, or you are in implementation or assessments, call upon REMS Group for expert guidance.

  • FDA Submission Prep: As an engaged member of your scientific and communications team, REMS Group leads efforts on a proactive basis to ensure that your FDA submission is comprehensive, defensible and approvable. In addition we employ contingency planning based on our experience with the process.
  • Implementation: REMS Group is experienced in creation of all elements such as medication guides, communication plans, elements to assure safe use (ETASU), and various additional implementation systems. We are especially knowledgeable in website and electronic-based implementation systems including point-of-purchase techniques.
  • Medical Meeting Outreach: One of the most vital aspects of implementation of REMS programs includes our key opinion leaders approach. KOLs are recruited to REMS certification programs, oriented and educated at our kiosk, set up in your exhibit display.
  • Advisory Boards: We conduct expert-level advisory board panels on an in-person or virtual basis that provide valuable input to your REMS efforts.
  • Educational Symposia: REMS Group creates and conducts satellite symposia in conjunction with medical meetings, and stand-alone symposia.
  • Training Sessions: Educating pharmaceutical sales representatives is a key business imperative. REMS Group conducts nation-wide training programs on an in-person basis. Our capabilities can be deployed during launch meetings, on an independent basis, or through the utilization of distance-learning techniques. In addition, we custom-design learning modules based on electronic media. Certificates of completion are issued in all cases.
  • REMS Physician/Nurse Support Program: Ongoing efforts to provide call-center services, patient guides, continuing education. Our Support Program is the pull-through effort which assures optimization of your pharmaceutical product.
  • “REMS Reporter”: A monthly newsletter which compiles the latest available information from FDA and reports on first-hand accounts of product management and legal and regulatory departments of pharmaceutical companies. Tracking various industry efforts and interviews with professionals on the cutting edge of REMS issues make this an essential read for all healthcare professionals. For additional information and to subscribe to this outstanding resource just call 201-225-1100.