Regulatory Operations Experts

Get the help you need with ePub Partners

At Electronic Publishing Partners LLC (ePub Partners), we specialize in eCTD submission outsourcing, meeting the highest standards in the industry. With extensive experience in regulatory operations, we are dedicated to delivering precise, compliant, and timely regulatory submissions for both pharmaceutical and biotechnology product applications.

We understand the complexities of eCTD format and ensure every submission aligns with ICH and FDA regulatory requirements, allowing your internal team to focus on drug development and strategic priorities, accelerating your pathway to market.

What are the benefits of outsourcing your eCTD submissions?

Expert Access

Gain immediate access to seasoned eCTD specialists, who can get your organization up-and-submitting quickly, or inherit an existing application

Cost Optimization

Eliminate the steep costs associated with purchasing specialized publishing software, and hiring/training dedicated regulatory operations staff

Compliance

Rely on our expertise of current ICH/FDA guidance and eCTD validation criteria, keeping you compliant and up-to-date with industry best practices

Scalability

Easily adjust resources to accommodate times of high submission volume, ensuring no delays and the flexibility to meet your project demands

Core Focus

Free your team to focus on high-value tasks, such as drug development and regulatory strategy, leaving the intricacies of eCTD format to us

Why choose Electronic Publishing Partners?

By partnering with us, you can rely on our wealth of expertise in publishing and submitting a wide array of regulatory documents. Our team is proficient in everything from presubmissions to advertising and promotional material, providing you with the assurance that your regulatory submission needs are in capable hands.

  • Pre-IND (or INTERACT) Meeting Requests & Briefing Packages

  • Initial Investigational New Drug (IND) Applications

  • Breakthrough Therapy or Fast Track Designation Requests

  • Responses to FDA Information Requests or Comments/Advice

  • Partial/Complete Responses to Clinical Hold Letters or Non-Hold Comments

  • Quality, Nonclinical, Clinical, or Multiple Module Information Requests

  • New Protocols, Protocol Amendments, or Investigator Information Amendments

  • Updates to Investigator’s Brochure (IB) or Investigational Labeling

  • Suspected Unexpected Serious Adverse Reaction (SUSAR) Initial Written Reports & Follow-Ups

  • Annual Reports (ARs), Development Safety Update Reports (DSURs), or IBD Harmonization Requests

  • Changes in Sponsor/Agent or Ownership Transfer/Acceptance

  • Transfer of Regulatory Obligation (TORO) or Letter of Authorizations (LOAs)

  • Initial Pediatric Study Plan (iPSP) or Pediatric Studies Waiver/Deferral Requests

  • Nonclinical Study Reports with SEND Datasets

  • Clinical Study Reports (CSRs) with SDTM and ADaM Datasets

  • End-of-Phase 1 (EOP1), End-of-Phase 2 (EOP2), Pre-NDA/BLA Meeting Requests & Briefing Packages

  • Notification of Clinical Trial Discontinuation, IND Inactivation, Reactivation, or Withdrawal

  • 120-Day Safety Update Reports

  • Mid-Cycle Communication (MCC) or Late-Cycle Meeting Requests & Briefing Packages

  • Chemistry, Manufacturing, and Controls (CMC) Supplements (CBE-0, CBE-30, or PAS)

  • Labeling, Efficacy, or Risk Evaluation and Mitigation Strategy (REMS) Supplements

  • Periodic Safety Reports (PADERs/PAERs and PSURs)

  • Post-marketing Requirements/Commitments Annual Status Reports

  • Lot Distribution Reports (LDRs) and Structured Product Labeling (SPL)

  • OPDP Advertising and Promotional Material (AdPromo)