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Regulatory Affairs Consulting

Regulatory Consulting Tailored to Your Needs

Our regulatory consultants have extensive experience in navigating the U.S. FDA submission process as well as international regulatory approvals, ensuring a smooth and efficient pathway to market.

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Overview

Regulatory Affairs Consulting for Medical Devices

Navigating the complex world of medical device regulations can be challenging. Our Regulatory Services provide end-to-end support to help you achieve FDA compliance and international approvals faster and with confidence. We combine deep expertise in regulatory affairs with a personalized approach, ensuring your medical device meets all necessary standards from product development to market entry. Whether you’re preparing a 510(k) submission or planning a global rollout, our team guides you through every step of the regulatory journey.

Why Strong Regulatory Compliance Matters?

In the medical device industry, regulatory compliance isn’t just a box to tick – it’s the foundation of market success. Proper regulatory strategy accelerates approvals, avoids costly delays, and builds trust with investors and customers. With constantly evolving regulations and high stakes (like patient safety and company reputation), having seasoned regulatory experts on your side is vital. We help you interpret complex FDA requirements, harmonized standards, and guidance documents so you can focus on innovation while we handle the compliance.

Comprehensive Regulatory Services We Offer

(Each service below is a dedicated page – click to learn more about that specific offering.)

US Agent Services Acting as your official U.S. FDA Agent for foreign manufacturers. We represent your company in communications with the FDA, ensuring you never miss important notices and helping to fulfill the FDA’s requirements for non-US companies. (For international device firms, a reliable US Agent is legally required and critical for smooth market entry.)
Pre-Submission Support Guiding you through FDA Pre-Submission meetings (Q-Submissions) and early communications. We help prepare briefing documents, formulate the right questions for the FDA, and coach your team on how to approach these meetings. Early feedback from the FDA can clarify requirements and save you significant time down the line.
513(g) Request for Classification Helping you obtain official classification determinations from the FDA. If you are unsure how your device is regulated or which pathway to pursue, our experts prepare your 513(g) request to get a clear answer from FDA on device classification and applicable regulatory controls. This prevents costly guesswork by clarifying whether your product needs a 510(k), PMA, or is exempt.
510(k) Submission Preparation Providing end-to-end support for FDA 510(k) premarket notification submissions. From determining substantial equivalence to compiling the entire 510(k) dossier, we ensure your submission is complete, accurate, and stands the best chance of a first-cycle clearance. (Our team has prepared countless successful 510(k)s, navigating requirements for device description, bench testing, labeling, and more.)
PMA Submission Managing the rigorous Premarket Approval (PMA) process for high-risk devices. We assist with compiling scientific evidence, clinical data, and manufacturing information to meet the FDA’s toughest requirements. Our regulatory scientists and writers will assemble a compelling PMA application and help you address FDA review questions so you can obtain approval for novel and Class III devices.
De Novo Classification Requests Guiding you through the De Novo process for novel devices with no predicate. For innovative technologies that don’t fit existing classifications, we prepare De Novo requests to establish a new device classification. We strategize the risk-based information needed and work to demonstrate that general and special controls can assure safety/effectiveness of your device, leading to a successful De Novo grant.
IDE Submission Helping you launch clinical trials with an Investigational Device Exemption (IDE). If you need to perform a clinical study for an unapproved device, we prepare the IDE application, including the investigational plan, informed consents, and safety monitoring procedures. Our team ensures you meet all FDA requirements to get approval to begin your clinical trial as soon as possible.
Regulatory Strategy Development Crafting a custom regulatory roadmap for your product’s lifecycle. We analyze your device, its risk profile, and global market goals to develop a clear plan: from identifying the correct regulatory pathway (510(k), PMA, De Novo, etc.) to timing of submissions and compliance milestones. A robust strategy early on saves time and resources by preventing missteps.
FDA Meeting Preparation & Representation Preparing you for critical meetings with the FDA and even representing your team during those interactions. We help develop meeting requests (e.g., Pre-Subs, advisory committee meetings) and rehearse Q&A scenarios. During the actual FDA meetings or teleconferences, our regulatory experts can lead discussions or support your presenters to ensure clarity and a positive outcome.
Labeling and Advertising Compliance Reviewing and advising on medical device labeling, marketing materials, and advertising for regulatory compliance. We make sure your device’s Instructions for Use, package labels, promotional brochures, and website content all meet FDA regulations (and FTC guidelines) to prevent misbranding issues. Our team helps you highlight your device’s benefits effectively without running afoul of regulatory restrictions.
Medical Device Listing & Registration Assisting with FDA device listing and establishment registration (often referred to as “MedDev Listing & Registration”). We ensure that your company and all your device products are properly registered in FDA’s databases, as required before marketing. This service is essential for both domestic manufacturers and foreign firms (who must also designate a US Agent). Keeping your FDA listings up to date is crucial for compliance and avoiding regulatory snags at import/customs.
Regulatory Risk Assessment Proactively identifying and mitigating regulatory risks in your project. We evaluate factors such as regulatory classification ambiguities, testing requirements, potential FDA concerns, and compliance gaps. By conducting a thorough risk assessment, we help you address issues early – for example, performing additional studies or improving documentation – so that when you submit to regulators, there are fewer surprises. This service reduces the chance of rejection, delays, or costly remediation after audits.

End-to-End Support

From initial regulatory strategy (figuring out what pathway your device needs) through submission prep, FDA engagement, and post-market compliance, ADB Consulting & CRO Inc. has you covered. Our team stays with you throughout the product lifecycle. For instance, after obtaining clearance or approval, we continue to support with things like post-market surveillance plans, periodic reporting, or handling any FDA 483 inspections related to your device. This cradle-to-grave approach means you have a consistent partner for compliance at every stage.

What Sets Our Regulatory Consulting Apart?

We know you have options when it comes to regulatory consulting, so we strive to deliver unmatched value and results:

Our regulatory consultants are former industry experts and include RAC-certified professionals. We have successfully managed 50+ regulatory submissions (510(k), PMA, etc.) adbccro.com and helped launch over 150 products globally, so we understand the nuances of agency expectations. When new FDA guidance or EU MDR regulations come out, we’re on top of it – and we adjust your strategy accordingly.

Regulatory advice isn’t one-size-fits-all. We take the time to learn the specifics of your device, technology, and business goals. This allows us to tailor our guidance. Whether you’re a startup with a first-in-class device or an established manufacturer entering a new market, we scale our services to your needs. Our team becomes an extension of your team, working closely with your engineers, scientists, and executives.

Delays in regulatory approval can burn cash and give competitors a lead. We emphasize speed without sacrificing quality. That means quick turnarounds on document reviews, prompt responses to FDA inquiries, and proactive identification of issues before they become roadblocks. Our familiarity with regulatory processes often allows us to anticipate what regulators will ask, so we prepare you to address those points in advance.

While FDA compliance is often the first priority (especially for U.S.-based companies), we also support international regulatory needs. Our services extend to EU CE Marking, UKCA, Health Canada licensing, and MDSAP preparations. If your strategy involves multi-country launches, we’ll coordinate a global regulatory plan that leverages documentation across markets efficiently.

As your regulatory partner, we hold ourselves to the highest ethical standards. Our advice will always prioritize patient safety and regulatory compliance over shortcuts. In the long run, this protects your company’s reputation and product integrity. We also practice what we preach – our own processes for delivering consulting services are ISO 9001 certified, ensuring consistency and quality in our work.

Lead Your Device to Market Success

With our regulatory experts by your side, you can approach submissions and approvals with confidence instead of stress. We aim not just to get you a one-time approval, but to embed regulatory success into your company’s culture – turning compliance into a competitive advantage. Many of our clients have gone on to achieve faster clearances and smoother audits thanks to the frameworks we helped put in place.

Ready to Navigate the Regulatory Maze?

Let’s chart the optimal course for your medical device. Contact us today for a consultation and let ADB CRO simplify the regulatory journey, so you can bring your innovative products to patients sooner. (Our team is U.S.-based and accustomed to working with clients across all U.S. time zones.) We’ll ensure that complex regulations never stand in the way of your medical innovation.

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