Pineprep
Pineprep LLC
Pineprep offers comprehensive regulatory services for medical device and IVD companies, specializing in FDA US Agent representation, Certificate to Foreign Government (CFG), Apostille & Legalization, and expert consulting to facilitate global market access.
Pineprep is a dedicated regulatory consulting firm assisting medical device and IVD companies in navigating complex global regulations. They specialize in securing FDA US Agent representation, essential for foreign establishments importing devices into the US. Pineprep also facilitates the acquisition of Certificates to Foreign Government (CFG), proving FDA compliance and enabling market entry in various international regions. Furthermore, Pineprep handles the apostille and legalization of essential documents, ensuring their validity for use in countries worldwide. Their expert consulting services cover the entire regulatory journey, from initial strategy development to post-market surveillance. With a focus on pragmatic solutions and efficient processes, Pineprep aims to streamline compliance and accelerate time-to-market for their clients, acting as a trusted partner in their regulatory endeavors.
About
**Who they are**
Pineprep is a regulatory consulting firm specializing in simplifying the regulatory process for medical device and in vitro diagnostic (IVD) companies. They aim to ensure products reach the market smoothly and efficiently.
**Expertise & scope**
* FDA US Agent representation for foreign establishments, acting as a liaison with the FDA.
* Assistance with Certificate to Foreign Government (CFG) acquisition for medical device registration in international markets.
* US Apostille and Legalization services for documents used in countries party to the 1961 Hague Convention Treaty or those requiring authentication certificates.
* Regulatory consulting services covering assessment of requirements, strategy development, and post-market surveillance.
* Support for companies without a US presence, fulfilling the FDA mandate to designate a registered US FDA Agent.
**Reputation / proof points**
* Based in Arlington, VA, with a physical business location in the US.
Pineprep is a regulatory consulting firm specializing in simplifying the regulatory process for medical device and in vitro diagnostic (IVD) companies. They aim to ensure products reach the market smoothly and efficiently.
**Expertise & scope**
* FDA US Agent representation for foreign establishments, acting as a liaison with the FDA.
* Assistance with Certificate to Foreign Government (CFG) acquisition for medical device registration in international markets.
* US Apostille and Legalization services for documents used in countries party to the 1961 Hague Convention Treaty or those requiring authentication certificates.
* Regulatory consulting services covering assessment of requirements, strategy development, and post-market surveillance.
* Support for companies without a US presence, fulfilling the FDA mandate to designate a registered US FDA Agent.
**Reputation / proof points**
* Based in Arlington, VA, with a physical business location in the US.
Additional information
Pineprep offers a suite of services designed to facilitate global market access for medical device and IVD companies. Their FDA US Agent service is crucial for foreign establishments importing devices into the US, ensuring prompt communication with the FDA and assisting with inspections. For international market entry, they provide Certificate to Foreign Government (CFG) acquisition, which serves as proof of FDA compliance. Additionally, their Apostille & Legalization services authenticate US-issued documents for use abroad. The company also provides comprehensive regulatory consulting to guide clients through various stages of the regulatory journey.
Key Highlights
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Specializes in FDA US Agent representation for foreign medical device and IVD companies.
Source
“Designate Pineprep as your registered FDA US Agent. We will serve as the liaison between the FDA and your medical device or IVD company.”
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Facilitates international market access by obtaining Certificate to Foreign Government (CFG) from the FDA.
Source
“Pineprep can assist you in accessing new markets by obtaining CFG documents from the US Food and Drug Administration (FDA) for your product on your behalf.”
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Provides US Apostille and Legalization services for regulatory documents.
Source
“We can get your documents apostilled and legalized on your behalf by the appropriate government authorities according to the requirements of various markets.”
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Offers comprehensive regulatory consulting for medical device and IVD companies.
Source
“Our experts will support you at all phases of your regulatory journey, from assessing regulatory requirements and developing regulatory strategies to post-market surveillance.”
Certifications & Trust Signals
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Maintains a physical business location in the US for FDA US Agent services.
Source
“US Agent must reside in the US or maintain a physical business location in the US and be available to answer the phone during normal business hours.”
Buyer Snapshot
Best for
- Foreign medical device and IVD companies seeking US FDA representation.
- Companies needing to authenticate US-issued regulatory documents for international use.
- Businesses requiring assistance with FDA compliance and market access strategies.
How engagement typically works
- Provides dedicated US FDA Agent representation.
- Offers end-to-end support for regulatory documentation and consulting.
- Acts as a liaison between clients and regulatory bodies.
Typical deliverables
- Designated US FDA Agent services.
- Obtained Certificate to Foreign Government (CFG).
- Apostilled and legalized regulatory documents.
- Regulatory strategy and compliance reports.
Good to know
- Best when clients require a US-based entity to act as their FDA US Agent.
- Most effective for companies navigating complex international regulatory requirements for medical devices.
HQ:
Arlington, US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, Pharmaceuticals, Biotech, IVD, Food & Beverage
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Registration Support:
Yes
Time Zone Coverage:
America/New_York
Inspection Support:
Yes
Emergency Contact24x7:
No
Product Type:
devices
Service Types:
US Agent Services, FDA Registration/Listing Support, Inspection Support, Regulatory Consulting
Additional us_agent_fda Details
Product Types
Medical Devices, In Vitro Diagnostics (IVDs)
Registration Support
Yes, for FDA establishment registration and device listing as prerequisites for CFG.
Recall Support
Not explicitly stated, but U.S. Agent role includes communication which could extend to recalls.
Inspection Support
Yes, assists FDA in scheduling inspections of foreign establishments.
Emergency Contact24x7
No, business hours are specified as Monday-Friday, 9 am - 6 pm.
US Entity State
Virginia
Onboarding Steps
The website mentions that for CFG, the establishment must be registered with the FDA, the device must be listed with the FDA, and the device must meet specific labeling and manufacturing requirements.
