Bentley Biomedical Consulting
Streamlining Medical Device and Drug Regulatory Compliance

The FDA constantly refines regulatory policies to ensure the safety and effectiveness of new drugs, devices, and biologics for end-users. In response, pharmaceutical manufacturers must stay current with these dynamic regulations to facilitate the timely market entry of their innovations. Bentley Biomedical Consulting, a regulatory affairs professional society (RAPS)-certified regulatory consulting company, is a leader in streamlining regulatory pathways for the life sciences niche. It helps medical device and drug manufacturers navigate intricate FDA compliance procedures and the submission process for device and IVD 510(k)s, De Novo submissions, PMAs, BLAs, TRG Letters, 505(b)(2)s and abbreviated new drug applications (ANDAs). Capitalizing on decades of experience, the company stays abreast of the evolving device, biologic and pharma regulatory landscape, and operating processes of entities like the FDA, ensuring the offered submission/filing guidance is relevant, timely, and accurate. This guarantees seamless approval of clients’ products while accelerating their commercialization globally.

Prioritize Addressing Prevalent Concerns of Pharmaceutical Manufacturers—Regulatory Expectations

Bentley Biomedical Consulting focuses on prevalent concerns, including inquiries into regulatory expectations, requirements, realistic timeframes for regulatory interactions, and the specific data and information related to claims. It also addresses advisable claims when entering a new market, whether for a novel drug or innovative device and prioritizes determining their readiness for regulatory engagement. The company assesses what information can be conveyed early, particularly with the U.S. FDA, through formal and informal means. Common early questions involve the adequacy of the information, including considerations for clinical studies and performance data.
To comprehend clients’ specific approval requirements, Bentley Biomedical Consulting starts the onboarding by measuring their familiarity with regulatory norms, i.e., if they are relatively new to the market with minimal compliance experience or a multinational company with prior knowledge. It then customizes the conversations accordingly, balancing formality and informality. These initial conversations encourage open and candid communication, creating an environment where clients feel free to express their requirements openly and without reservation.

Next, Bentley Biomedical Consulting evaluates device/IVD design & development as relevant, or for drugs the drug history and whether a drug is a new entity or existing drug with a novel administration method. If the drug qualifies for submission as a new method of administration for an existing drug, there is an appropriate regulatory pathway. Known as a 505(b)(2) in the U.S., this drug approval path has gained prominence in the last 15 years, overtaking the traditional 505(b)(1). It identifies opportunities for drugs with previous approvals to transform with a new administration method, leading to an entirely new product life.
“In my role, I also determine the optimal path for approval, considering the generic drug, ANDA versus the 505(b)(2), which stands out due to its ability to leverage the FDA's understanding of overall drug safety and efficacy for new administration methods or claims,” says Shepard G. Bentley, president and principal consultant of Bentley Biomedical Consulting.

On the device side, Bentley Biomedical Consulting stresses enabling developers, manufacturers, and potential submitters to understand their device's risk classification. This involves recognizing key aspects essential for portraying the device's performance in terms of safety, effectiveness, and usability. When software is part of the equation, there's an additional emphasis on validating it to ensure secure usage through cybersecurity measures and compliance with various software-related validation requirements. Mr. Bentley gets involved early to determine the desired device label. He asks clients about their dream label, understanding what can, should, and will be communicated. This sets the stage for a sequence, starting with an approved label and then expanding claims gradually by accumulating more data and performance results, whether from lab tests or clinical trials. He organizes this process, emphasizing the importance of time and ensuring clients consider the long-term potential of their product code.

An essential factor is navigating the pre-market process with an eye on reimbursement. While the company doesn't handle reimbursement codes directly, it develops a regulatory process to align with existing codes or enable clinical data to support a new reimbursement code application. This strategic approach is initiated from the beginning, ensuring a successful outcome.

“Clients trust our consultancy, highly customized to their requirements. For example, if they have any desired product labels, we tailor the regulatory pathway to actualize the aspirations post-compliance,” says Bentley.

Before advising for device submission or drug filing, the company carefully considers the distinctive operational procedures and work culture of regulatory bodies.

Employing a blend of formal and informal communication with officers, it finds the optimal time for submission and formulates the best-suited procedures to be followed. This guarantees a quick, cost-effective, and hassle-free approval process.

The Evidence of the Company’s Adeptness

Bentley Biomedical Consulting showcased its regulatory expertise by helping a client save 80 percent of the time and 90 percent of the budget in securing approval for a high-risk medical device claim. Initially, the client opted to submit the complete device at once to the regulatory entities. As the device was created to treat a life-threatening disease, such submission would have attracted stringent regulations, potentially impacting the approval. It advised them for a de novo submission, sequentially seeking approval for different components before submitting the entire device. It also presented the device as a treatment option to prevent patients from advancing to the life-threatening condition. This shift accelerated the approval process, enabling the product’s timely launch.

Post-FDA Approval Assistance Apart from helping clients during submissions/filing, the company also helps them adhere to changing regulations and keeps their products relevant in the market in the long run. It has periodic meetings with clients’ management to discuss regulatory changes that may affect their products and help strategize accordingly. It follows ISO 13485, under which its management reviews cover current and forecasted regulatory changes. The approach involves more than just monitoring official channels like the FDA website or the Gazette of Canada; it extends to exploring draft guidance documents, which reflect the current mindset of regulatory bodies. Though unofficial, MDCG guidelines from the European Council offer highly regarded perspectives on satisfying EU regulators. Publications from Health Canada and Therapeutic Goods Agency in Australia are analyzed to understand existing and potential regulatory changes. Mr. Bentley is subscribed to newsletters like CDRH news, professional organizations like RAPS, and private news links for insights into regulatory thinking. This applies to both medical devices and drugs, involving medical device authorities such as European Competent Authorities, EMA, or the FDA’s CDRH and Office of Combination Products. Specifically on the drug front, similar strategies are employed. Monitoring EMA in Europe, as well as the FDA’s CDER and CBER in the U.S., enables the company to stay ahead of evolving drug regulations. This multifaceted approach ensures that Bentley Biomedical Consulting remains well-informed and agile in adapting to the dynamic regulatory landscape.

Organizational Backbone

A major contributor to Bentley Biomedical Consulting’s success is its workforce. Its management has adopted a unique strategy, where the company seamlessly partners with other consultancies to contractually engage experts from diverse domains like microbiology, clinical evaluation research, and engineering as per the project requirements. The goal is to facilitate life sciences innovators in connecting with a regulatory affairs consultant who can skillfully articulate submissions and present the innovations in a way that regulators can easily accept, ensuring they grasp the value these advancements bring to life sciences. In the pharma devices and drugs sector, where companies are increasingly choosing FDA approval as the initial regulatory clearance for their drugs, Bentley Biomedical Consulting’s global exposure to regulatory bodies helps them traverse the entire compliance path with ease.