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Regulatory Operations
Complex Regulatory Applications Streamlined through Quality based in Experience
Our Regulatory team provides high-quality publishing, submission, and lifecycle management services with the goal of helping our clients reach the best possible outcome.
Our team brings decades of knowledge and hands-on experience with thousands of successful eCTD submissions, including:
- INTERACT Meetings
- Pre-INDs
- INDs
- DMFs
- BLAs
- NDAs
- ANDAs
Our Difference
Biologics Consulting’s Regulatory Operations team brings a strong focus on quality, compliance, and error-free submissions with 7 full-time dedicated employees with decades of combined eCTD experience, delivering thousands of submissions with a technical approval rate of 100%.
Our Services
We offer clients an array of tools and services that enhance collaboration, streamline the application drafting process, and reduce regulatory review times, including:
- Guidance-compliant, reviewer-friendly eCTD submissions
- Reliable and secure transmission to FDA and Health Canada via our Electronic Submissions Gateway (ESG)
- Lifecycle Management of eCTD applications ensuring that reviewers have the latest information at their fingertips
- Customizable, compliant document templates
- eCTD compliance consultation and training
Book a Consultantion with an Expert
Do you need more information about our services? We would love to hear from you!