US FDA Regulatory Support for Medical Devices, Drugs, Biologics, and Combination Products
Get your product from lab to market efficiently, while staying compliant at every stage.
Navigating the complex regulatory landscape can be challenging. Our regulatory experts specialize in guiding medical devices, drugs, biologics, and combination products through every step of the FDA approval process.
Our experienced regulatory team guide companies at all stages, helping mitigate regulatory risks and get to commercialization.
[Metrics: # Devices Approved Globally, # Pre-Submission Meetings Managed, #Years of consulting experience, #Projects, #Countries]
Get into the hands of patients faster
Our regulatory strategies are tailored to support your unique needs across the full range of design, development, and post-market support. We guide you through applicable regulations, guidelines, processes, and technical standards.
With extensive experience from pre- to post- market strategies, our team stays up to date on the latest regulations to ensure your medical device, drug, biologic, or combination product can get approved quickly.
Extensive Expertise
Our team has years of experience in regulatory affairs, providing you with accurate and reliable guidance.
Streamlined Processes
We simplify the regulatory journey, helping you avoid common pitfalls and expedite approval.
Dedicated Support
From initial consultation to final submission, we are with you every step of the way, ensuring clear communication and effective solutions.
Regulatory Services
Our FDA Regulatory Support Services
General Regulatory Consulting
Ad-Hoc support for attending meetings, answering questions, and providing on-demand regulatory advice.
Flexible assistance tailored to your specific needs, ensuring you have expert guidance whenever required.
Regulatory Strategy
Comprehensive regulatory strategy development for your target markets to help achieve clarity on device classification and regulatory pathway
Analysis of product codes, potential predicates, guidelines, and standards.
Thorough review of past precedents, relevant guidelines, standards, and ongoing regulatory initiatives.
Assessment of market requirements to provide streamlined strategies for your go-to-market plan.
Q-Submission Meetings
Pre-Submission Meeting
Prepare and submit Pre-Submission Information Packets to FDA.
Facilitate teleconference or face-to-face meetings with FDA to obtain feedback on regulatory strategy and testing plans, alongside you
Assist in preparing presentation slides and conducting rehearsals prior to meetings.
Prepare and submit Pre-Submission Information Packets to FDA.
Facilitate teleconference or face-to-face meetings with FDA to obtain feedback on regulatory strategy and testing plans, alongside you
Assist in preparing presentation slides and conducting rehearsals prior to meetings.
Informational Meeting
Prepare Informational Meeting Packets for FDA review.
Organize and attend teleconference meetings to familiarize FDA with your device.
Provide meeting minutes and summarize FDA recommendations.
Prepare Informational Meeting Packets for FDA review.
Organize and attend teleconference meetings to familiarize FDA with your device.
Provide meeting minutes and summarize FDA recommendations.
Breakthrough Device Designation (BDD)
Assess eligibility for BDD and prepare application packets.
Facilitate frequent communication with FDA to expedite development and review processes.
Submit BDD applications and provide ongoing support during FDA review.
Assess eligibility for BDD and prepare application packets.
Facilitate frequent communication with FDA to expedite development and review processes.
Submit BDD applications and provide ongoing support during FDA review.
Safer Technologies Program (STeP)
Assess eligibility for STeP and prepare application packets.
Facilitate frequent communication with FDA to improve safety and expedite approval.
Submit STeP applications and provide ongoing support during FDA review.
Assess eligibility for STeP and prepare application packets.
Facilitate frequent communication with FDA to improve safety and expedite approval.
Submit STeP applications and provide ongoing support during FDA review.
Sprint Discussions
Develop primary topics and goals for Sprint Discussions with FDA.
Prepare supporting materials and attend discussions to resolve novel issues quickly.
Provide meeting minutes and summarize FDA recommendations.
Develop primary topics and goals for Sprint Discussions with FDA.
Prepare supporting materials and attend discussions to resolve novel issues quickly.
Provide meeting minutes and summarize FDA recommendations.
Market Submissions
510(k) Submission
Prepare and submit 510(k) applications.
Organize and present product-related information to meet FDA requirements.
Provide ongoing support during FDA review, including response to additional information requests.
Prepare and submit 510(k) applications.
Organize and present product-related information to meet FDA requirements.
Provide ongoing support during FDA review, including response to additional information requests.
Special 510(k) Submission
Prepare expedited 510(k) submissions for modifications to previously cleared devices.
Organize and present information on device changes and risk control measures.
Prepare expedited 510(k) submissions for modifications to previously cleared devices.
Organize and present information on device changes and risk control measures.
De Novo Application
Prepare and submit De Novo applications for devices without suitable predicates.
Provide comprehensive documentation to demonstrate safety and effectiveness.
Prepare and submit De Novo applications for devices without suitable predicates.
Provide comprehensive documentation to demonstrate safety and effectiveness.
Premarket Approval (PMA) Submission
Prepare and submit PMA applications for Class III medical devices.
Provide detailed documentation to demonstrate safety, effectiveness, and benefit-risk analysis.
Prepare and submit PMA applications for Class III medical devices.
Provide detailed documentation to demonstrate safety, effectiveness, and benefit-risk analysis.
Emergency Use Authorization (EUA) Submission
Prepare and submit EUA packets for devices intended for emergency use.
Ensure all necessary information and evidence are included for timely FDA review.
Prepare and submit EUA packets for devices intended for emergency use.
Ensure all necessary information and evidence are included for timely FDA review.
Market Submission Gap Analysis and Drafting
Conduct gap analysis to identify and address deficiencies in documentation for any market submission type.
Draft and prepare complete submission packages for regulatory review.
Conduct gap analysis to identify and address deficiencies in documentation for any market submission type.
Draft and prepare complete submission packages for regulatory review.
Compliance and Audit Services
Marketing Claims Compliance Audit
Ensure marketing materials align with FDA regulatory requirements.
Review all marketing materials, including websites and social media posts, for compliance.
Ensure marketing materials align with FDA regulatory requirements.
Review all marketing materials, including websites and social media posts, for compliance.
Device Master File Submission (MAF)
Prepare and submit MAFs to safeguard trade secrets while providing FDA access to pertinent information.
Prepare and submit MAFs to safeguard trade secrets while providing FDA access to pertinent information.
513(g) Packet & Submission
Draft and submit 513(g) requests to obtain FDA feedback on device classification and regulatory requirements.
Draft and submit 513(g) requests to obtain FDA feedback on device classification and regulatory requirements.
Drug Regulatory Services
Type B (End-of-Phase) Meeting
Prepare meeting request packets and attend Type B meetings to obtain FDA feedback.
Prepare meeting request packets and attend Type B meetings to obtain FDA feedback.
Pre-IND and IND Submission
Prepare and submit IND applications, including necessary documentation and interactions with FDA.
Prepare and submit IND applications, including necessary documentation and interactions with FDA.
Pre-ANDA Meeting and NDA Submission
Prepare Pre-ANDA meeting packets and NDA submissions, ensuring compliance with FDA requirements.
Prepare Pre-ANDA meeting packets and NDA submissions, ensuring compliance with FDA requirements.
Drug Master File (DMF) Submission
Prepare and submit DMFs to support regulatory applications.
Prepare and submit DMFs to support regulatory applications.
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
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Accelerate your product to market pathway.
Our experts are ready to help you hit your regulatory goals.
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