Medical devices continue to play a vital role in the advancement of modern medicine - from neurostimulators and joint replacements to implantable defibrillators, stents, coils and screws - medical devices are everywhere, constantly evolving to incorporate new technologies and always adapting to ever-changing standards of care.
The Medical Device development and regulatory approval processes are both complex and highly nuanced. Biologics Consulting has extensive experience in providing regulatory, product development and quality systems consulting services to manufacturers of medical device products.
Our team of consultants is comprised of former FDA reviewers, managers or high level officials, all with extensive experience in every aspect of the medical device regulatory and product development process, from nonclinical testing and verification through manufacturing, design and evaluation of clinical trials to commercialization. This includes expertise in each of the following elements of the product development process: pharmacology/toxicology, software, quality management, product manufacturing, medical device biocompatibility, clinical trial design and evaluation, immunogenicity assessment, statistics, GTP, GMP, GLP and GCP regulatory compliance, and U.S. Agent Services.
Our team’s knowledge and hands-on experience with hundreds of successful PMAs, 510(k)s, HDEs, pre-Subs, IDEs, 513gs and other submissions spans the full spectrum of medical device product development pathways. We are intimately aware of the intricacies associated with each pathway – expertise that positions our clients for the most successful outcome possible.
Biologics Consulting offers more than consulting services and regulatory support to its clients. Our team provides a full complement of medical device development consulting services to support your product development process. Biologics Consulting’s expertise extends from medical device design, verification and validation testing through clinical trial design, oversight and submission preparation, and FDA support services. In each client engagement, we view ourselves as a success partner and a member of the medical device development team.
Our mission is to provide guidance and value at every step of the device product development process, from concept to clinical trials to commercialization. Regardless of the current stage of your product development, the Biologics Consulting team brings the scientific knowledge, regulatory know-how and industry experience necessary to step in and provide hands-on assistance to your team.
Every Step of the Way: Biologics Consulting’s Device Expertise
Our experts will collaborate with your team to assess your product development plan, define all applicable scientific and regulatory requirements, and craft a customized product development and testing strategy that minimizes cost and time to clinical trials, regulatory approval and commercialization. Whether your proposed device is an improvement on an existing product or a revolutionary breakthrough requiring a full PMA submission, our team brings decades of FDA and product development experience.
Biologics Consulting will work with your team to identify the appropriate pathway for approval, whether it be a 510(k) submission, HDE application, de novo petition, or PMA. Once a plan of action has been established, Biologics Consulting will be with you every step of the way to manage preliminary documentation and testing, provide hands-on leadership at meetings with the FDA and support your regulatory submission with advice to ensure the best possible submission. Our goal is to craft a document that meets the FDA’s expectations, leading to an efficient and timely review process.
Once your IDE application has been submitted (if your device type requires an IDE), we will support your product development team with advice during the IDE review and approval process. Our consultants leverage their unique “insider” perspective to interpret Agency requests as well as to provide guidance on the latest Agency thinking, giving you the best chance for a successful outcome while eliminating the guesswork and costly delays that plague many Agency interactions.
Once an IDE approval has been secured, the Biologics Consulting team supports your clinical trial efforts with clinical consulting services tailor-made to your product. From organizing trials to analyzing data generated and auditing returns, the Biologics Consulting team brings the scientific knowledge and proven industry experience necessary to ensure your trials are effective and efficient. We also know how to translate clinical trial results into compelling stories that resonate with the FDA, NIH and RAC – putting your product in the best possible position for rapid approval and delivery to market.
In addition to our expertise in nonclinical testing, clinical trial design and FDA submission support services, Biologics Consulting employs a team of experts in all aspects of testing, manufacturing, storage, and distribution, so you can rest assured that all aspects of your operation are fully compliant with FDA regulations and 21 CFR 820 requirements.
Our team is well positioned to assist your organization in preparing and submitting your application. During the submission preparation process, we provide hands-on support and guidance in interpreting CDRH, CDER and CBER interactions. Our team can help translate raw nonclinical and clinical data into a compelling story that will resonate with FDA reviewers, and lead to the best possible outcomes for your medical device application.
Once your device application has been approved and your product is ready to go to market, the Biologics Consulting team is able to provide assistance in overseeing manufacturing and quality control, drafting requested periodic updates for the FDA (if required) and assisting your team through additional development and commercialization processes.