Regulatory Services
At Nilo Medical Consulting Group, we guide clients through the full spectrum of regulatory requirements for medical devices, combination products, and drug/biologic submissions. Our deep expertise and collaborative approach ensure your submissions are complete, compliant, and strategically positioned for success.
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We provide end-to-end support for a wide range of U.S. and international medical device submissions, including:
510(k), De Novo, Premarket Approval (PMA), PMA Supplements, Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), and 513(g) submissions
Q-submission/pre-submission meeting preparation
Breakthrough Device and Safer Technologies Program (STeP) Designation requests
Technical documentation for EU Medical Device Regulation (MDR), including Clinical Evaluation Reports (CERs)
Registration and listing
Regulatory body interactions and deficiency response support
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Navigating regulatory pathways for combination products requires specialized knowledge across multiple FDA centers. Our experience includes:
Drug-device combinations such as drug-eluting stents and bioactive graft materials
Strategic planning and coordination across Office of Combination Products (OCP), Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER)
Regulatory pathway assessment and cross-center submission strategy
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We support both early-stage and commercial drug and biologic development through:
eCTD-compliant Investigational New Drug (IND) submissions
Pre-IND meeting planning and briefing packages
Orphan Drug Designation requests
Program development for non-clinical pharmacology and toxicology studies
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We help clients design and implement performance testing plans that meet FDA expectations the first time—saving time and cost. Our support includes:
Test strategy and protocol development
Regulatory alignment to ensure data meets submission standards
When clinical data is needed, full Clinical Research Organization (CRO) services to manage trial execution
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Engaging with the FDA is a high-stakes opportunity. Our team has experience on both sides of the table and can help you:
Prepare for and facilitate FDA meetings (Q-submissions/Pre-submissions, Type B/C meetings)
Develop clear messaging and materials that communicate complex issues efficiently
Maximize meeting outcomes with actionable guidance
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We help build and maintain robust quality systems that comply with global regulatory standards, including:
Quality Management System (QMS) development to meet 21 CFR 820 (QMSR) and ISO 13485
Risk management in line with ISO 14971
V&V planning and execution
UDI compliance, 483 remediation, and audit preparation
Regulatory change assessments and post-market strategy
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We offer tailored staff training programs to strengthen in-house regulatory, quality, and clinical knowledge. Options include:
Customized virtual or on-site sessions
Good Clinical Practice (GCP) training for clinical teams
Risk, quality, and regulatory process workshops designed for your specific product portfolio