Flexible, Creative Strategies
Today’s competitive medical marketplace requires that companies remain flexible and embrace complex and creative clinical and regulatory strategies. The downstream effects of an early regulatory strategy can be significant. It is at this point, more than any other in the product development cycle, that a well thought out multi-prong approach can make the difference between product approval and acceptance and failure to commercialize in a timely and/or cost efficient manner.
BioMDg provides a wide range of scientific and marketing support solutions for a range of medical devices, combination products, drug development and gene and stem cell therapeutics. Specific areas of medical research expertise include: cardiovascular disease, metabolic conditions, neurological and neurosurgical treatments, cancer diagnostics and treatment, ophthalmic and orthopedic research.
Concept Evaluation
BioMDg provides services to evaluate new product concepts, including tailored scientific business plans, regulatory strategy development for multiple regions, and due diligence on new technologies. We also assess existing data, facilitate communication with regulatory bodies like the FDA, and determine pre-clinical and clinical requirements. Additional offerings include down-classification petitions, breakthrough designation requests, and orphan product approvals.
Pre-Clinical & Clinical Testing
BioMDg identifies applicable consensus standards and FDA guidance documents for products and recommends the optimal animal models when necessary. They conduct risk analysis for packaging, sterilization, and biocompatibility, as well as define bench testing requirements.
Marketing
BioMDg assists with marketing upon study completion, including 510(k) premarket notifications and preparing design dossiers for CE marking. We also handle PMA, BLA, and NDA submissions, as well as Canadian device license applications, and provide support for regulatory submissions, panel preparation, and data analysis. Additional services include writing clinical reports and facilitating breakthrough designation discussions.
Clinical Development
BioMDg develops clinical testing programs to support safety and effectiveness including site selection, IRB/IBC submissions, and informed consent documents. We also manage regulatory submissions, case report form development, and clinical database design, while providing full CRO services for trial oversight. Additional offerings include protocol writing, investigator agreements and brochures, and handling IDE, IND, HUD/HDE, and orphan designation requests.
Early Marketing Initiatives
We offer comprehensive services in distribution chain management, both domestic and international, and supports early revenue generation and post-market surveillance. Our early marketing services also assist with international marketing, post-marketing studies, and regulatory/clinical strategies, including expanded indications and strategic planning.
Training
BioMDg has developed training programs based on our experience with the regulatory process and with frequently asked questions regarding regulatory issues. Our courses are available for medical devices and their regulation, QSR, good clinical practices, and risk management. We can also design training programs for specific clients upon request. All courses can be presented privately at locations and on dates convenient to the individual client.
