Frequently Asked Questions

We provide regulatory consulting, clinical research (CRO), quality, and product lifecycle support for medical device, biotechnology, combination product, and pharmaceutical companies. Rather than telling clients what they can’t do, we help them navigate what they can do—understand their options, evaluate the risks and benefits of each approach, and recommend the best path forward. Whether you need support with a single project or an end-to-end development program, we provide practical, strategic guidance to help you move confidently from concept to commercialization.
We partner with startups, growth-stage companies, and established global firms across the US, EU, and other key markets. Whether you need project-based consulting, full-service support, or fractional regulatory/quality/clinical team members, we tailor our approach to your needs, your budget, your product, and your timeline.
If you’re unsure where to start, we recommend a brief, no-cost discovery call. We’ll review your goals, timelines, and development progress to recommend the right combination of services—regulatory, clinical, quality, or product development—to move your program forward efficiently.
Both. Many clients need end-to-end regulatory and clinical support, including fractional leadership, while others need help with a single submission, protocol, or quality system element. We scale up or down based on your needs.

We prepare and manage a full range of submissions, including 510(k), De Novo, PMA, PMA Supplements, IDE, INC, HDE, and 513(g) requests. We also support Q-submissions/Pre-submissions and meetings, Breakthrough Device Designation requests, STeP designations, orphan drug designations, and pre-INDs.
Yes. We advise on meeting strategy, prepare briefing packages, manage FDA interactions, and help you communicate complex issues clearly and effectively so your meeting time is used well. While clients may lead discussions if they prefer, we strongly recommend having our team facilitate FDA meetings to guide the conversation, address FDA questions in real time, and help achieve the most productive outcome.
Absolutely. Determining the optimal pathway is one of the most important early steps, and our team helps evaluate risk, classification, predicate devices, testing requirements, and regulatory strategy across the U.S. and global markets.
Yes. We help with technical documentation, Clinical Evaluation Reports (CERs), notified body interactions, conformity assessment planning, and global strategy across EU, UK, and other regulatory jurisdictions.

We build and optimize quality systems aligned to 21 CFR 820, ISO 13485, and ISO 14971. We also help with internal audits, remediation, and inspection readiness.
Yes. We help teams understand what FDA will look for, prepare documentation, strengthen CAPA processes, and build confidence before an inspection.
We follow ISO 14971 to build risk management files, hazard analyses, risk-benefit assessments, and mitigation strategies that align with both regulatory expectations and your product’s clinical use.

Yes. We’ll review your technology, intended use, risks, and predicate landscape to guide you toward the correct pathway. Not everything needs a submission, and we’re happy to support justifications that avoid more rigorous FDA pathways.
We can help determine this for you. Classification affects everything—testing, submission type, and regulatory burden—so identifying it early is crucial.
Earlier is almost always better. Early regulatory input and clinical trial strategy prevents rework, reduces cost, and accelerates time to market.

We combine former FDA insight, boutique flexibility, and deep regulatory–clinical–quality integration. Clients value our precision, responsiveness, and ability to translate complex requirements into clear, actionable plans. We are unique in our tailored approach, offering individualized services to meet clients where they are.
We can typically begin within 1–3 weeks, depending on scope. For time-sensitive submissions or studies, we work with clients to prioritize critical-path items.
Bring anything you have: design files, device descriptions, intended use, past regulatory correspondence, or testing results. If you don’t have much yet, that’s perfectly fine. We’ll assess where you are, identify what’s needed, and guide you through the process step by step.
After an initial no-cost consultation, we prepare a tailored proposal outlining scope, timeline, deliverables, and cost. Because every device and development stage is unique, our recommendations reflect your specific needs.

Yes. We provide full CRO services, including protocol development, site selection and training, monitoring, data oversight, safety management, and clinical study reporting. We support device, diagnostic, drug, and combination product trials across the product lifecycle, including first-in-human and feasibility studies, pre-market pivotal/validation trials for both non-significant risk and IDE trials, and post-marketing studies.
Yes. We create study protocols, also referred to as clinical investigational plans (CIPs), and all supporting materials such as CRFs, ICFs, investigator brochures, monitoring plans, safety plans, and patient-facing content.
Yes. Our regulatory and clinical teams work together on early feasibility studies, pivotal study designs, and all documentation required for both IDE and IND submissions.
Yes. We routinely submit the Central IRB submissions for our clients, and we advise sites and investigators on completing their local IRB submissions.
Definitely. We routinely partner with other CROs to fill gaps or add strategic expertise—particularly for FDA-facing work, monitoring oversight, protocol refinement, and clinical study reports (CSRs).
Yes. We can help you determine if your planned clinical trial is likely to be non-significant risk or significant risk and develop a NSR justification to submit to your IRB to support the determination.

We help teams integrate regulatory, quality, and usability requirements into early design decisions. This includes design inputs, user needs, risk management, human factors guidance, and planning for verification and validation (V&V) activities.
Yes. We help plan, document, and execute usability and human factors testing so your device meets regulatory expectations and supports safe, effective use.
Absolutely. Early alignment with regulatory expectations saves significant time and cost. We review protocols for accuracy, adequacy, and regulatory alignment so testing generates “submission-ready” data the first time.

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