Not only existing products, but we focus more on innovative products.

InnoPin is dedicated to bringing high-quality innovative products to the US market in a legally compliant and appropriate way, allowing our manufacturer and consumer customers to have peace of mind.

Do you know how to manage regulatory compliance risks？
Do you know the best of FDA regulatory strategies for innovative products？
Do you know how to communicate with FDA effectively and timely?

Our service

Will prepare you before you make initial contact with the FDA

With InnoPin, you can choose experts with direct FDA experiences as your US agents or expert RA advisor for product dossier preparation / registration/ notification ensuring compliance and avoiding red flags.

Our American expert consultants collectively have more than 30 years of federal government and private sector experiences.

Our mission is to assist our clients to bring their products to the US marketplace in the most efficient way with regulatory compliance.

Our strategy is to closely work with clients , share our expertise in RA and technical areas, and formulate a feasible yet affordable action plan to move forward swiftly.

Our tactics is to customize the most suitable solutions for our clients to avoid risk, conserve resources, achieve milestones, and maximize programsuccess by timely strategizing, preparing, and submitting the notification or registration applications to regulatory authorities globally, especially US and China.

➢ Regulatory Strategy and Action Plan Development
We help clients in formulating regulatory strategies, identifying / managingrisks, and developing regulatory action plans that ensure clients’immediate success and long-term growth.

➢ Regulatory Application Preparation, Review and Submission
This includes, but not limited to, US regulatory application (FDA, EPA, and USDA etc.) market survey, data gap analysis, study design, dossier drafting and/or reviewing, and submission as clients’ US agent or expert RAadvisor. When you are ready, we are ready!

FDA Connection, Communication and Compliance (3C): We are ready for effective and timely interactions with the FDA solely on your behalf. Our 3C focus is to get your questions answered, move your program forward timely with minimal regulatory risk and no regrets, and give your product access to US market. Your application acceptance leading to product approval and successful launch is our shared goal. In particular, INNOPIN supports your FDA meeting preparation and set up, program representation to FDA and FDA response (meeting minutes) reviews.

➢ Regulatory Matter Life-Cycle Management
Upon a successful regulatory submission, our clients may still need guidance and advice even after the FDA approval or post product launch surveillance or mass production phases. To ensure long term business success, INNOPIN can be your product life-cycle management partner. We are successful only when you are truly successful!