Our Services

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

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Regulatory Strategy

• Design Regulatory Strategies that can significantly accelerate product development timelines and reduce costs.

• Align clients' business goals, risk tolerance, and budget with the most suitable regulatory pathways.

• 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.

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Global Filings
With extensive knowledge across the regulatory spectrum—including clinical, non-clinical, CMC, Design Controls, 21 CFR Part 11, and companion diagnostics—we ensure compliance with each requirement.

Our experts compile, format, publish, and submit biopharmaceutical 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, 505(b)(2), BLA, Orphan Drug Designation

• Medical Devices: IDE, 510(k), PMA, HUD, HDE, CE Mark

• Specialized: Compassionate Use/Expanded Access, Fast Track Designations, Certificates of Origin

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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: Transmitting submissions via our FDA gateway, with 21 CFR Part 11 compliance for secure storage and archival.

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