eCTD Consultation and Submission Services for FDA Compliance
Streamlining Your Path to Regulatory Approval
At ClinReg Partners, we specialize in providing comprehensive electronic Common Technical Document (eCTD) services to pharmaceutical, biotechnology, and medical device companies. With the FDA mandating eCTD submissions for INDs, NDAs, BLAs, and other applications, navigating this complex process can be daunting. Our team ensures your submissions are accurate, timely, and compliant, accelerating your regulatory approval journey.
ClinReg Partners Core Services
1. Expert Consultation
Comprehensive assessments of your regulatory submission needs.
Tailored strategies to meet FDA's eCTD requirements while aligning with your timelines and goals.
2. Document Preparation & Review
Formatting and editing technical documentation to FDA standards.
Structuring nonclinical, clinical, and CMC modules for clarity and compliance.
3. Validation & Publishing
Rigorous quality control to ensure error-free submissions.
Insertion of document links, bookmarks, and metadata for seamless navigation.
4. eCTD Submission Management
Secure electronic submissions via FDA's Electronic Submissions Gateway (ESG).
Lifecycle management, including amendments, supplements, and annual reports.
5. Ongoing Support
Post-submission maintenance and archival on compliant servers.
Real-time tracking and updates on submission statuses.
Why Choose ClinReg Partners?
Experienced Team: Decades of expertise in regulatory strategies, publishing and submission management.
Efficiency-Focused: We identify bottlenecks and implement solutions to save you time and resources.
Global Expertise: Capabilities to meet US, EU, and international submission requirements.
Secure Processes: 21 CFR Part 11-compliant systems for confidentiality and data integrity.
Your Competitive Advantage
Outsourcing your eCTD submissions to ClinReg Partners allows you to focus on core business operations, reducing the need for costly in-house systems and staff. Our proven track record ensures seamless execution, helping you achieve faster market access and regulatory success.
Let ClinReg Partners guide you through the complexities of eCTD submissions—partner with us for confidence and compliance every step of the way.
Contact us today to schedule a consultation!
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