Services – Pineprep

With Pineprep,

Expand into various markets.

We can help you meet the legal and regulatory requirements of various markets and stay compliant so you can concentrate more on your business. From required documents to agency services, we got you covered.

Expert Solutions for your Regulatory Challenges

Navigating the complex landscape of medical device regulations can be daunting. Pineprep specializes in simplifying the regulatory process for medical device and in vitro diagnostic (IVD) companies, ensuring your products reach the market smoothly and efficiently. Our comprehensive services are designed to support you every step of the way, from initial development to post-market surveillance.

We Offer

Expert Regulatory Guidance

With years of experience in the medical device industry, our team of compliance specialists provides expert guidance tailored to your specific needs. We stay up-to-date with the latest regulatory changes, ensuring your compliance strategies are always current and effective.

Global Reach

Our services help your products reach numerous markets across the globe. Whether you need assistance with US FDA regulations or market entry in Europe, Latin America, Asia, Middle East, or beyond, we’ve got you covered.

Dedicated Support

We pride ourselves on offering personalized service. Our dedicated team works closely with you, providing professional, confidential, and prompt assistance to address all your regulatory needs.

Independent Representation

As an independent third-party representative, we prioritize your interests. We work for you, ensuring your regulatory responsibilities are handled with the utmost care and professionalism.

US Agent

We serve as liaison with FDA on behalf of foreign establishments, ensuring prompt and responsive communication.

Certificate to Foreign Government

We obtain the FDA CFG so that our clients can expand to various markets.

Apostille & Legalization

We conduct the process of certifying the necessary documents on our clients’ behalf.

Consulting

After assessing client’s current situation, we provide consulting services for medical device regulatory compliance.