What We Do
Comprehensive Regulatory Affairs Services
From early-stage strategy through product approval, Universal Regulatory Inc provides end-to-end regulatory expertise for the FDA-regulated pharmaceutical and biotechnology industry.
Regulatory Strategy Consulting
We provide strategic regulatory guidance to help clients navigate complex FDA and global regulatory pathways. Our expertise spans early development through product approval, including regulatory pathway selection, risk assessment, and development program design.
Includes
- ▸Regulatory pathway assessment and selection
- ▸Development program design and optimization
- ▸Risk-benefit analysis and mitigation strategies
- ▸Global regulatory strategy for US, EU, and Asia markets
Regulatory Submissions Preparation and Planning
Universal provides comprehensive support for all types of regulatory submissions, from initial INDs through marketing applications. We ensure submissions are complete, accurate, and strategically positioned for approval.
Includes
- ▸IND, CTA, NDA, BLA, MAA preparation and review
- ▸Submission planning and project management
- ▸eCTD formatting and electronic publishing
- ▸Response to agency questions and deficiency letters
Health Authority Negotiations
Our team has a proven track record of successful interactions with US and EU health authorities. We provide expert representation and strategic communication support throughout the regulatory review process.
Includes
- ▸FDA meeting preparation and facilitation (Type A, B, C)
- ▸EMA scientific advice and protocol assistance
- ▸Agency correspondence and response strategy
- ▸Advisory committee preparation and support
CMC Regulatory Support
Chemistry, manufacturing, and controls (CMC) regulatory expertise is critical to product development and approval. Universal provides specialized CMC regulatory support across all phases of development.
Includes
- ▸CMC sections for IND, NDA, BLA, MAA submissions
- ▸Drug substance and drug product regulatory strategy
- ▸Manufacturing change management and supplements
- ▸Analytical method validation regulatory support
Ready to Discuss Your Regulatory Needs?
Contact us to learn how Universal Regulatory Inc can support your drug development program.
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