About Us
Medical Devices and Pharma LLC is a professional provider of expert regulatory consulting services for manufacturers of medical devices and pharmaceutical products regulated by the United States Food and Drug Administration (FDA), Health Canada, the European Union (EU), and globally.
Our website not only provides regulatory information and assistance, but it is also a consumer-oriented resource designed to present timely safety news, helpful information, and analysis for users of medical devices and pharmaceutical products.
Our Mission
The mission of Medical Devices and Pharma is to provide the highest quality personalized professional regulatory services to our clients.
We maintain vigilance and provide timely safety information to consumers of medical device and pharmaceutical products, and provide insight and guidance to companies in FDA-regulated industries regarding their products, processes, innovation, product safety, and enforcement.
Who We Serve
We proudly support:
- Medical Device Manufacturers seeking compliance with QMSR and ISO 13485
- Startups and SMEs navigating FDA regulatory requirements for the first time
- Regulatory and Quality Professionals looking to expand their expertise
- Educational Institutions preparing the next generation of regulatory experts
Regulatory and Quality Information at Your Fingertips
We designed the Medical Devices and Pharma website to present critical industry information in a well-organized and easy-to-navigate format. We stay up-to-date with regulatory agency announcements and activities, so visitors to the site will see current information about medical devices, pharmaceuticals, biologics, combination products, and other regulated medical products.
Contact us
We are available to respond to regulatory questions, strategies, or managed projects. Do you have regulatory questions about your medical device or pharmaceutical product? Let us know – please contact us and we can provide regulatory guidance and advice for upcoming regulatory projects.
Regulatory and Quality Headlines
Why Not Natural Organic Moringa Capsules Recalled
Why Not Natural Organic Moringa Capsules Recalled Over Possible Salmonella Contamination Editor's Note: This January 28...
Live it Up Super Greens Recalled Over Salmonella Contamination
Live it Up Super Greens Recalled Over Possible Salmonella Contamination Editor’s Note: The original recall notice was...
FDA Approves First Generic Drug for Equine Cushing’s Disease
An important step in expanding treatment access for horses with PPID The U.S. Food and Drug Administration has approved...
FDA Approves First Oral Treatment for Canine Lymphoma
Approval Granted With Minor Use/Major Species (MUMS) Pathway The U.S. Food and Drug Administration has granted full...
FDA Grants Full Approval for Canine Epilepsy Drug
Approval Granted After Expanded Conditional Pathway The U.S. Food and Drug Administration has granted full approval to...
FDA Advisory for Contaminated Raaw Energy Dog Food
The U.S. Food and Drug Administration (FDA) has issued a public advisory warning pet owners not to feed eight identified...
FDA Approves First Generic Fenbendazole Oral Suspension
Defendazole™ (fenbendazole) 10% Oral Suspension The U.S. Food and Drug Administration has approved Defendazole™...
FDA Approves First Generic for Bovine Respiratory Disease
nixiFLOR, the first generic version of Resflor GOLD The U.S. Food and Drug Administration has approved nixiFLOR, an...
FDA Approves Drug to Delay Canine Congestive Heart Failure
Vetmedin is the first drug to go from an expanded conditional approval to fully approved The U.S. Food and Drug...
FDA Completes Risk Review of Canine Freeze-Dried Plasma
Freeze-Dried Plasma for Emergency Use in Dogs The U.S. Food and Drug Administration (FDA) has completed a risk review of...