No-Cost CRM Demonstration | NO SERVICE PROVIDED | – US FDA CPP

ATTENTION: This is a No-Cost Demonstration | NO SERVICE WILL BE PROVIDED — Sample listing for the US FDA CPP (Certificate of a Pharmaceutical Product) for Human Drugs or Biologics Export. This is a demonstration only, provided at no cost, to showcase the structure and presentation of a regulatory service listing and Project CRM.

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The CPP Service covers the preparation, submission, and follow-up of a Certificate of Pharmaceutical Product (eCPP) request to the U.S. Food and Drug Administration (FDA). This includes verification of product approval status, confirmation of manufacturing site information, and submission via the FDA eCATS/CDER or BECATS/CBER eSubmitter system by a verified US FDA agent to obtain a US FDA CPP Export Certificate.

NRA: FDA/Food and Drug Administration
Country: USA
Categories: Biosimilars, BioTech, Cell & Gene Therapies, CMC Services, Combinations & Drug–Device, Pharmaceuticals or Small-Molecule Drugs, Tissue- & Blood-Derived, Vaccines & Immuno-Biologicals

SERVICE DESCRIPTION:

Regular Service Includes:

• Standard CPP Eligibility Verification and Submission
• First Certificate US FDA State Fee 
• One round of the potential mitigation in case of Return for Action Letter (3-day response limit)
• CPP obtaining

Optional Service Includes:

• Extended CPP with supplemental documents (e.g., Formulation Page), Remarks, etc.
• Federal (US Department of State (DOS)) Apostille, or State of Florida Notarized Apostille

The service ensures issuance of an original FDA CPP in digital format with a scannable QR code, suitable for submission to foreign regulatory authorities.

REQUIREMENTS:

1. Proof of fully refundable RAPAhub payment (PoP) incl. FDA fee (first certificate is already included, additional invoices will be issued when the project starts (request from RAPAhub Admin if needed), and international shipment label copy (UPS, FedEx, or USPS) for Standard Letter-Sized Envelope 9×12 inches if the optional CPP Apostille delivery is required;

FDA Unit	Category	First Certificate FDA fee	Subsequent Certificates FDA fee
CDER	Human drugs	$175	$90 (second), $40 (each additional)
CBER	Biologics	$175	$175 (second), $85 (each additional)

2) The company name requesting the CPP, location, and contact information;

3) CPP target country;

4) Number of certificates needed;

5) Marketing authorization status:

– FDA Approval Letter for NDA / ANDA / BLA number (if approved) as a PDF file

– FDA Product Listing Number (e.g., NDC)

– Application number if under FDA review;

6) Product Information:

– Proprietary (trade) name in the United States

– Nonproprietary (INN) name

– Dosage form & strength

– Active ingredient(s)

– Package or Container Label (PDF)

– Outer Package Label (PDF)

– Package Insert (PDF);

7) Manufacturer Details:

– Manufacturer Name incl. address of each manufacturing site involved (API, finished product, packaging)

– Role of each site (e.g., drug substance manufacturer, final dosage manufacturer)

– Marketing Authorization Holder (MAH) in the US with full address (if different from the Manufacturer)

8) Formal SOW with written confirmation that no supplemental documents (e.g., Formulation Page), Remarks, US Department of State (DOS) Federal Apostille, or State of Florida Notarized Apostille are required, or Formal SOW with written confirmation that supplemental documents (e.g., Formulation Page), Remarks, etc., are required, except DOS Apostille or Florida Notarized Apostille.

PROJECT MANAGEMENT WORKFLOW

US FDA CPP Service:

Phase I Eligibility Verification

TIMELINE: 3 workdays

DELIVERABLES: (1) eCPP Draft, (2) FDA Application Draft for approval

Phase II FDA Submission

DESCRIPTION: Submission via the FDA eCATS/CDER or BECATS/CBER system

TIMELINE: 3 workdays

DELIVERABLES: (1) FDA Letter w/Proof of Submission

Phase III FDA Approval

DESCRIPTION: –

TIMELINE: 20 workdays

DELIVERABLES: (1) RfA Response approved by the customer, followed by CPP approval if accepted, (2) FDA Rejection Letter if so, (3) FDA Approval Letter, Digital eCPP w/traceable QR code, and eCPP Package.

Important note: no supplemental documents (e.g., Formulation Page), Remarks, US Department of State (DOS) Federal Apostille, or State of Florida Notarized Apostille is provided under the Standard CPP Service. An Extended CPP Service is required for obtaining the eCPP Package with supplemental documents (e.g., Formulation Page), Remarks, etc.

MILESTONE: FDA Decision -> TASK LIST: Phase III FDA Approval

PAYMENT RELEASE TO SELLER: Upon completion of the Phase III Milestone (applicable for Packages A through D)

 

ADDITIONAL REQUIREMENTS for the optional Phase IV: 

Formal SOW that a US Department of State (DOS) Federal Apostille, or a State of Florida Notarized Apostille, is required (define which one); also clear definition of whether digital scans are accepted or an original Apostille printed version shipping is required, maybe both. For international delivery of printed CPP Apostilles, prepare a shipment label (UPS, FedEx, or USPS) for a standard 9×12-inch letter-sized envelope. Alternatively, be ready to cover the shipping cost — request the Project Manager to confirm the amount and the RAPAhub admin to issue a pass-through cost invoice once the cost is clarified.

Important note: The U.S. Department of State (DOS) Federal Apostille verifies the original signature of the FDA official who issued the eCPP and typically takes up to three weeks to complete. In contrast, the State of Florida Notarized Apostille confirms the authenticity of the FDA CPP through Notary certification and is usually finalized in less than one week. 

Optional Phase IV-FL Florida Notarized Apostille

DESCRIPTION: Florida State Notarized Apostille under the internationally recognized Hague Apostille Convention.

TIMELINE: 5 workdays

DELIVERABLES: (1) Digital Scanned, or Printed, or both State of Florida Notarized CPP Apostille delivered to your email, your door, or both. 

Optional Phase IV-DOS DOS Apostille

DESCRIPTION: Federal Department of State (DOS) Apostille under the internationally recognized Hague Apostille Convention,

TIMELINE: 20 workdays

DELIVERABLES: (1) Digital Scanned, or Printed, or both US Department of State (DOS) Federal CPP  Apostille delivered to your email, your door, or both.

MILESTONE: Optional CPP Apostille   -> TASK LIST: Optional Phase IV-FL Apostille   -> TASK LIST: Optional Phase IV-DOS Apostille

PAYMENT RELEASE TO SELLER: Upon completion of the Phase III Milestone (applicable for Packages E through F)

 

COMPARE SERVICE COST AND TIMELINES

Service included	Procedure	Apostille	Total Cost with 1 CPP included	Additional Subsequent CPP FDA fee	Total Timeline
Package A	Standard US FDA CDER/CBER CPP	without Apostille	$1,275.00	CDER $90 (second), $40 (each additional) CBER $175 (second), $85 (each additional)	26 workdays
Package B	Extended US FDA CDER/CBER CPP	without Apostille	$2,515.00	CDER $90 (second), $40 (each additional) CBER $175 (second), $85 (each additional)	26 workdays
Package C	Standard US FDA CDER/CBER CPP	with State of Florida Notarized  Apostille	$2,175.00	CDER $90 (second), $40 (each additional) CBER $175 (second), $85 (each additional)	31 workdays
Package D	Extended US FDA CDER/CBER CPP	with State of Florida Notarized  Apostille	$3,415	CDER $90 (second), $40 (each additional) CBER $175 (second), $85 (each additional)	31 workdays
Package E	Standard US FDA CDER/CBER CPP	with Federal DOS  Apostille	$2,175.00	CDER $90 (second), $40 (each additional) CBER $175 (second), $85 (each additional)	46 workdays
Package F	Extended US FDA CDER/CBER CPP	with Federal DOS  Apostille	$3,415	CDER $90 (second), $40 (each additional) CBER $175 (second), $85 (each additional)	46 workdays

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REFUND POLICY:

All fees are final; however, they are initially collected into a “RAPAhub virtual escrow lockbox”. In the event of an unsuccessful outcome, fees may be returned to the customer (payer) in accordance with the RAPAhub Refund Policy in full, excluding any applicable official fees and pass-through costs that were paid in advance, if required, as well as 10% RAPAhub Service Commission, in addition to applicable third-party payment processing fees (e.g., PayPal, credit card processing fees, or bank charges) for customer satisfaction.

IMPORTANT:

Please refer to the full RAPAhub Terms and Conditions for complete details. All incoming and outgoing payments are subject to a 10% RAPAhub Service Commission, in addition to applicable third-party payment processing fees (e.g., PayPal, credit card processing fees, or bank charges).

As a non-binding statement of intent, RAPAhub Administration may, at its sole discretion, grant an additional non-fiat bonus to both the payer and the payee at the end of the following fiscal year. This initiative forms part of RAPAhub’s Corporate Policy to foster user retention and partially share corporate equity in recognition of the platform’s growth and success, proportional to the individual’s cash flow.

 

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FOR EDUCATIONAL PURPOSES – PROJECT CRM

Click on http://bit.ly/43gcEBh  to view the actual listing US FDA CPP | Human Drugs or Biologics Export Certificate by Vlad Reznikov, or
Click on https://bit.ly/4oqIPXc to view or download the same Product Listing Draft Sample, and
Click on http://bit.ly/4qhQlW4 to view or share the Regulatory Affairs Service Listing Template, also
Click on http://bit.ly/4nMUdfX  to view No-Cost CRM Demonstration | NO SERVICE PROVIDED and purchase it FOR FREE from the Explore Service → Marketplace to view the actual Project CRM Sample at My Dashboard → My Projects menu, see below:

It’s important to complete the Project CRM setup simultaneously by “purchasing” the Start New Project (TEMPLATE) for free from the Explore Service → Marketplace menu or clicking on https://rapahub.com/product/start-new-project/, requesting the Manager role in the new project by sending a message to RAPAhub Admin, and then filling it out under My Dashboard → My Projects with Phases, Tasks, Deliverables, Timelines, and Milestones, when you submit your Regulatory Affairs Service Listing to RAPAhub Admin by mail info@RAPAhub.com for for 24-hour review and publication. 

NEED HELP? Request a virtual call with Dr. Vlad Reznikov if you need assistance filling out the listing or project template by clicking https://calendly.com/patternofusa/intro to book a Zoom meeting at any convenient time.