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. Our services include:

  • Regulatory Submissions for Medical Devices, Combination Products, and Drugs & Biologics

  • Verification and Validation (V&V) Testing Requirements

  • FDA Meetings and Regulatory Strategy 

  • Quality Systems and Post-Market Support 

  • Regulatory Education and Training

Concept of MDR Medical Device Regulation

Medical Device Regulatory Submissions

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-submissions and 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 

Combination Product Regulatory Submissions

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

Drug & Biologic Regulatory Submissions

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 nonclinical pharmacology and toxicology studies

Verification & Validation Testing Requirements

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 

FDA Meetings & Regulatory Strategy

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

Quality Systems & Post-Market Support

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 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 

Regulatory Education & Training

We offer tailored staff training programs to strengthen in-house regulatory, quality, and clinical knowledge. Options include: 

  • Customized virtual or onsite sessions 

  • GCP training for clinical teams 

  • Risk, quality, and regulatory process workshops designed for your specific product portfolio