Our Services

ClinReg Partners provides regulatory and clinical research consultancy services to companies. Our regulatory and clinical research experts evaluate and provide a gap analysis of your current overall state of compliance, and provide a health check roadmap to ensure requirements are met, and answer any questions that you may have.

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Clinreg Partners offers: 

1.  Gap Analysis (This will include comparative analysis to assist with the indication, protocol development, and possible claims development for the future label)

2.  Regulatory Strategy Development (this can include the EU, and other countries if needed)

3.  Regulatory operation (any writing and document generation)

4.  Regulatory publishing

5.  Regulatory eCTD and XML generation

6.  Regulatory document validations

7.  FDA gateway Submission

8.  Regulatory Intelligence

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Regulatory Strategy

By doing a detailed gap analysis, we will design a complete Regulatory Strategy that ensures an accelerated approach if qualified.  We prepare a detailed timeline according to the eCTD requirements for any of your submissions.

• We align your business goals, risk tolerance, and budget with the most suitable regulatory pathways.

• We develop efficient global registration plans, maximizing the re-use of essential clinical, non-clinical, CMC, and engineering/testing data across international markets to streamline the approval process globally.

• We provide guidance and advice for all your CMC needs, including stability requirements, API manufacturing source changes, and more. 

 

Regulatory Operations

Manage the practical aspects of regulatory compliance, including the preparation, submission, and management of documentation required by regulatory bodies. ClinReg Partners Regulatory operations teams ensure that all submissions are accurate, timely, and adhere to the specific guidelines set forth by authorities. ​

Both functions are integral to the successful development and commercialization of medical products, ensuring that they meet all necessary regulatory requirements and reach patients safely and efficiently.

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Global Filings
With extensive knowledge across the regulatory spectrum—including clinical, non-clinical, and CMC, we ensure compliance with all the global health authority requirements. 

For your publishing needs, our experts compile, format, publish, and submit regulatory filings electronically via the FDA’s Electronic Submissions Gateway (ESG) using the eCTD format and manage eCopy submissions for 510(k) and PMA medical devices.

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Types of Filings:

• Drugs and Biologics: IND, NDA, ANDA, BLA, Orphan Drug Designation, CTA, MAA

• Medical Devices: 510(k), PMA,

• Specialized: Compassionate Use/Expanded Access, Accelerated programs such as Fast Track, Orphan Drug, and Breakthrough designation requests

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Publishing - eCTD Services

The electronic Common Technical Document (eCTD) submission process is a critical yet often resource-intensive requirement in the product development lifecycle. Required by the FDA for INDs, NDAs, DMFs, and other filings, this submission process can pose significant cost and operational challenges.

ClinReg Partners’ comprehensive eCTD Services are designed to streamline all your regulatory publishing needs.

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Each client is paired with a dedicated submission expert who serves as a single point of contact, ensuring smooth coordination with ClinReg Partners' internal regulatory and publishing teams. Our commitment to meticulous detail and client satisfaction drives the quality of our eCTD process.

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Comprehensive eCTD Services

• Project Management: Coordinating all regulatory submissions from start to finish.

• Document Preparation: Formatting, editing, and preparing documents and references.

• Hyperlinking and Verification: Ensuring all document links are functional and properly embedded.

• Initial Submissions: IND, NDA, ANDA, BLA, and eDMF submission and ongoing maintenance.

• Amendments and Supplements: Publishing and preparing updates as needed.

• Cloud-Based Portal: Secure, cloud-based submission portal for accurate, timely submissions.

• Secure Transfers: Transmit submissions via our FDA gateway, with 21 CFR Part 11 compliance for secure storage and archival.

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