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OUR SERVICES
FDA Registration Status
Verification
We offer a specialized service to verify the FDA registration status of products. As professionals and experts in navigating the intricacies of FDA approval processes, we ensure accurate and thorough verification. This service is tailored precisely for clients like you. Trust us to swiftly verify the current regulatory standing of products, providing you with the assurance you need.
Innovative Products
Innovation plays a vital role in product development, and the FDA actively supports products that may provide meaningful advances in public health. Understanding how your product may fit within these categories is important, as it can influence the regulatory pathway, review process, and development strategy. Our consultants help clients evaluate these opportunities and navigate the appropriate FDA pathways with clarity and confidence.
Medical Devices
What may seem like a medical device in the ordinary sense may not always align with how the FDA defines and regulates a medical device. This distinction is critical, as the correct device identification directly determines the applicable regulatory pathway, submission requirements, and compliance obligations. Our consultants help you evaluate your product through the lens of FDA regulations and guide you through the requirements needed to move forward with confidence.
OTC Drugs
OTC drug products are subject to distinct FDA regulatory pathways, and selecting the right pathway is essential for compliance. Depending on the product's intended use, ingredients, claims, and marketing strategy, a drug may fall under an IND, NDA, or OTC pathway—each with its own requirements and regulatory expectations. Our consultants work closely with you to assess the appropriate pathway and develop a tailored strategy to help move your product forward with confidence.
Foods & Dietary Supplements
Food and dietary supplements safety are fundamental to consumer protection, and FDA requirements are designed to ensure that food products are manufactured, labeled, and imported with proper controls in place. From preventive controls and HACCP considerations to nutrition labeling, allergen declarations, and FSVP obligations for importers, food compliance requires a comprehensive approach. Our consultants help you understand the applicable requirements, strengthen your compliance program, and prepare your food products for the US market with confidence.
COSMETICS
As the cosmetics industry continues to innovate, regulatory expectations are becoming more complex and increasingly demanding. While innovation drives growth and creates new opportunities, product safety and compliance must remain at the center of every market strategy. With MoCRA now reshaping the US cosmetics regulatory landscape, brands, manufacturers, and responsible persons must be prepared to meet evolving FDA requirements. Our consultants help you navigate these obligations with clarity and confidence, so your business can move forward while staying compliant.
Initial Importer
For foreign manufacturers, finding distributors registered as initial importers with the FDA is not easy because most distributors in the US do not want to manage the complicated responsibilities of the initial importer.
Our services are not only we serve as a regulatory requirement for foreign/domestic manufacturers, but we also assist in navigating the complexities of medical device regulations
Testing Services
The right scientific data is essential to demonstrate your product's safety, performance, and effectiveness. Depending on the product type and intended use, this may involve biocompatibility testing, EMC testing, performance testing, or well-designed clinical studies. With many possible ways to support your product, selecting the right testing strategy is critical. Our consultants help you identify the most appropriate data requirements and build a tailored pathway to support your regulatory and market goals.
Quality Management System / cCGMP
A strong Quality Management System is not one-size-fits-all. It must be designed and customized around each facility's role in product design, manufacturing, distribution, labeling, storage, and related operations. FDA regulations, including 21 CFR Part 820 and Parts 210/211, establish quality requirements to help ensure product safety and consumer protection. Our consultants help you build, tailor, and strengthen your QMS or cGMP system to support both regulatory compliance and long-term business growth.
Clinical Studies
Great ideas require strong scientific support to become credible, marketable, and compliant. Clinical studies can help demonstrate whether your product or concept is effective, beneficial, and safe—but designing and conducting the right study requires careful planning, regulatory awareness, and extensive resources. From study design and risk evaluation to regulatory alignment and documentation, our experienced consultants help you build the structure needed to support your claims and move your innovation forward with confidence.
Advisory
Navigating the intricate realm of FDA regulations can pose challenges, even for seasoned professionals. However, engaging the services of advisory consultants can alleviate the burden, streamline operations, and enhance the efficiency of your business. Beyond providing an effective regulatory strategy, an advisory consulting group offers opportunities for expansion and ultimately higher profitability. Whether you are an established business owner or embarking on a startup venture, the inclusion of an advisory consultant brings a multitude of advantages.
SmartEntry Service
SmartEntry is Provision’s exclusive U.S. retail setup solution,
designed to help your FDA-compliant products seamlessly transition into actual sales in the U.S. market.
From offline retailers such as Target and Walmart to online platforms like Amazon and TikTok Shop,
we provide tailored strategies and hands-on execution to ensure successful entry into the right sales channels.
Go beyond certification—
from compliance to commerce, partner with Provision.
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RealTime FDA™
When exporting to the United States, navigating customs and distribution can be complex. If any FDA-related issues emerge, Provision's Real-Time FDA Service offers an unparalleled advantage: our U.S.-based experts will directly intervene in real-time to resolve problems quickly, avoiding costly delays or penalties. This crucial, on-the-ground support is a key differentiator from foreign consulting firms that lack the ability to address U.S. domestic challenges.
C2C (Compliance-to-Commerce) Service
We offer comprehensive Compliance-to-Commerce service as your supplier, including conducting production from FDA-compliant manufacturers, managing all FDA requirements such as registrations and labeling, handling importing and customs. Our expertise extends to coordinating logistics and ensuring your products meet the standards of major retailers and online platforms like Amazon and Walmart. We also provide ongoing support for any FDA compliance issues during distribution.
