Regulatory Affairs Consulting
An international regulatory consultant you can depend on
VTI proudly offers expert national and international Regulatory and Compliance consulting services to help your company fulfill your compliance requirements. Our regulatory consultants are former federal and international regulatory experts.
VTI professionals have years of individual and collective experience within FDA regulated and international industries. Our team of Regulatory Consultants are equipped with the expertise, skills, and insight to make qualified recommendations you can trust. We have supported regulatory preparation and filings for clients worldwide.
We connect with the leading regulatory and industry experts to keep us abreast of developments that might affect your company. Additionally, we regularly participate in industry associations such as RAPS, ISPE and ASQ.
FDA Submissions
VTI prepares, reviews, and manages FDA submissions across drug, biologic, and device pathways — including 510(k), PMA, and De Novo for medical devices, and IND, NDA, ANDA, and BLA for pharmaceuticals and biologics. Whether you're filing for the first time or responding to agency questions on an active review, our team helps you compile a complete, defensible package.
Agency Meetings & Strategy
How you engage with the FDA can shape your entire development timeline. VTI prepares clients for pre-submission and milestone meetings — Type A, B, and C — helping you frame the right questions, anticipate agency concerns, and walk in with a clear strategy.
International Registrations
Bringing a product to market beyond the U.S. means navigating a patchwork of regional requirements. VTI supports international registrations and market entry — from EU MDR and CE marking to registrations across other global markets — aligning documentation and strategy across jurisdictions.
Regulatory Pathway Consulting
The most costly regulatory mistakes happen early, in classification and pathway selection. VTI helps you determine the right regulatory pathway from the start — assessing classification, predicate strategy, and submission type — so your program is built on the correct foundation.
Frequently Asked Questions
What does a regulatory affairs consultant do?
A regulatory affairs consultant guides a company through getting a product approved and keeping it compliant — from choosing the right regulatory pathway, to preparing FDA submissions, to managing agency interactions and international registrations.
Which FDA submissions does VTI prepare?
VTI prepares and manages submissions across drug, biologic, and device pathways — including 510(k), PMA, and De Novo for medical devices, and IND, NDA, ANDA, and BLA for pharmaceuticals and biologics.
What is an FDA pre-submission or milestone meeting?
These are formal meetings with the FDA — commonly Type A, B, and C — that let a company align on strategy before or during a submission. VTI prepares clients for these meetings, helping frame the right questions and anticipate agency concerns, which can save months of rework later.
Can VTI help with international product registrations?
Yes. VTI supports international registrations and market entry, including EU MDR and CE marking, aligning documentation and strategy across jurisdictions rather than starting over in each market.
How do I know which regulatory pathway is right for my product?
The correct pathway depends on product classification, predicate strategy, and submission type — and getting it wrong early is one of the most costly regulatory mistakes. VTI assesses these factors up front so your development program is built on the correct foundation.
Talk to a Regulatory Consultant
