Overview
Maneuvering through the federal regulatory review and approval process can be daunting, and years of research and investment can hang in the balance. Medical device, pharmaceutical, biotechnology, and other life sciences companies look to EBG Advisors to craft comprehensive, practical, and innovative solutions tailored to their particular needs and goals. We are adept at guiding clients (ranging from startup life sciences companies to many of the largest medical device manufacturers) through the maze of regulatory requirements and keeping them abreast of industry developments and trends.
Our consultants have real-world experience working inside federal regulatory agencies and within the life sciences industry. And many of our consultants have backgrounds that combine scientific, technical, industry, and legal knowledge and experience. Our clients benefit, in terms of the quality and efficiency of advice, when the learning from these disciplines is integrated into the options presented within a legal and regulatory framework.
In addition, our consultants have in-depth knowledge of the medical device environment. Medical device clients value our ability to anticipate change, optimize Food and Drug Administration (FDA) submissions, lessen costs spent during the submission process, maximize product revenue and profits, and strengthen their competitive advantage.
FDA Regulatory Clearance and Approval
Clients rely on EBG Advisors to support them through the FDA clearance and remediation process as well as other federal and state agency requirements. Using our vast experience in this area, we help clients successfully navigate the regulatory quagmire. Drug and medical device manufacturers also turn to us to assist them in bringing new products and innovations to market more quickly and efficiently.
EBG Advisors steers clients through many other facets of the regulatory clearance and remediation process, from determining the best way to collect the scientific and clinical evidence needed by regulators to building an appropriate health economics case for reimbursement.
Our FDA regulatory support services also include:
- Guiding early product development and investigational phases
- Assisting with FDA regulatory clearance and approval
- Helping with quality system remediation
- Helping with business planning and reimbursement
- Counseling on post-approval compliance and enforcement
- Advising on regulatory opportunities and other issues
- Assisting with licensing and technology transfer, supply chain and distribution, and clinical trials
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Projects
Events
Insights
Insights
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown
- PublicationsA Topic-Based Analysis of FDA Responses to FOIA Requests1 minute read
- BlogsUnpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?
- BlogsUnpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents18 minute read
- PublicationsIs CMS Ignoring the Realities of Biopharmaceutical Costs?2 minute read
- BlogsUnpacking Averages: FDA FOIA Response Times by Topic of Request23 minute read
- PublicationsA Patchwork in Need of Permanent Repair: The U.S. Framework for Recommending and Covering Preventive Care2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The FDA Plans to Regulate Far More AI Tools as Devices. The Industry Won’t Go Down ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Why Congress Quietly Just Gave the FDA More Power”3 minute read
- BlogsFDA Issues Orphan Drug Exclusivity Policy That Could Be a Catalyst for Future Litigation8 minute read
- PublicationsCOVID-19 Vaccine Prices Are Going Up. It Shouldn’t Be Our Focus.2 minute read
- BlogsUnpacking Averages: Creating an Industry-Specific Index to Track the FDA Regulatory Environment15 minute read
- BlogsUnpacking Averages: Finding Medical Device Predicates Without Using FDA’s 510(k) Database6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Torres Says Regulatory Alignment a Pressing Consideration for AI Change Control ...October 24, 20222 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Software to Predict Risk of Sepsis, Stroke Should Be Regulated as a Medical Device ...October 11, 20224 minute read
- BlogsUnpacking Averages: Using Natural Language Processing to Extract Quality Information from MDRsOctober 3, 202214 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Acknowledges Shortcomings of Pre-Cert Pilot in Report”October 3, 20226 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Talks Takeaways from Software Precert Pilot”September 27, 20222 minute read
- BlogsUnpacking Averages: Assessing FDA’s Focus on Enforcing 510(K) Requirements on ImportsSeptember 6, 202212 minute read
- Media CoverageBradley Merrill Thompson Mentioned in “FDA Draft for Digital Tech in Clinical Trials Languishes Despite Agency’s ...September 1, 20221 minute read
- PublicationsCOVID-19 Vaccination and the Fetal Cell Line Conundrum for Employee Religious ObjectionsAugust 11, 202210 minute read
- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program” ...August 3, 20222 minute read
- PublicationsCOVID-19 Vaccine and Monoclonal Coverage: A Focus of the 2023 Medicare Physician Fee Schedule Proposed RuleAugust 1, 202210 minute read
- Media CoverageRichard Hughes’ Article on Immunization Access Cited in “A Twenty-First Century 'Vaccines for Children' Program” ...July 12, 20223 minute read
- BlogsUnpacking Averages: Common Root Causes Driving Medical Device RecallsJuly 5, 20229 minute read
- BlogsUnpacking Averages: Violations Found in Medical Device Warning LettersJune 1, 202214 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Ends Pre-Cert but Could Revisit in the Future, with Congress’ Help” ...May 31, 20222 minute read
- BlogsThe VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to FruitionMay 20, 20226 minute read
- Publications
Deconstructing Genus Medical Technologies, LLC v. FDA: A Misunderstood Court Decision
16 minute read - Media CoverageBradley Merrill Thompson Quoted in “Racial Equity Increasing in Device Trials, but Reporting Remains Low”March 29, 20222 minute read
- Media CoverageBradley Merrill Thompson Quoted in “3 Key FDA Topics for Medtechs in 2022”February 2, 20224 minute read
- Media CoverageBradley Merrill Thompson Mentioned in “FDA Combo Products Guidance Offers More Flexibility for Cross-Labeling” ...January 31, 20222 minute read
- BlogsUnpacking Averages: Likelihood of FDA Medical Device InspectionsJanuary 4, 20226 minute read
- PublicationsPrescription Digital Therapeutics Don't Need a Physician3 minute read
- BlogsUnpacking Averages: FDA Review Time for 510(k)s5 minute read
- PublicationsCommentary: Digital Health Companies Should Stay Away from FDA in 20212 minute read
- PublicationsPostmarket Responsibilities for Medical AI: Part III — FDA Should Not Expand Its Oversight of Commercialized AI ...3 minute read
- BlogsCurrent Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk ...5 minute read
- PublicationsPostmarket Responsibilities for Medical AI: Part II — What Industry Should Do in Commercializing Medical AI2 minute read
- PublicationsPost-Market Responsibilities for Medical AI: Part I – FDA's Plan to Increase Its Oversight3 minute read
- Blogs7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 20205 minute read
Contact
EBG Advisors is prepared to assist you with undertakings ranging from launching products to obtaining regulatory approval and legal representation. Please provide us with an overview of how we may be of service, or, if you have any questions, let us know and we’ll direct them to the right consultant.
Joanna Pashos
Assistant Director EBGA
EBG Advisors, Inc.
JPashos@ebgadvisors.com
T: 202.861.1822