Regulatory Affairs Services

Uniphar provides regulatory affairs services to support product development across small‑molecule drugs, biologics (including vaccines), medical devices, combination products, and companion diagnostics. Our teams partner closely with Sponsors to define regulatory strategy and carry it through execution—from early planning through global regulatory submissions. Uniphar seamlessly integrates with Sponsors’ teams, combining regulatory strategy and hands‑on execution within a delivery model driven by science, planning, regulatory insight, and quality.

Regulatory Strategy

Effective regulatory execution starts with a strategy tailored to the product, indication, and development stage. Uniphar delivers regulatory strategy services that align scientific data with global regulatory expectations and are built for practical execution.

Regulatory strategy services include:

• Global regulatory pathway assessment and planning
• Indication analysis and target population selection
• Product labeling
• Regulatory positioning and submission planning

Our regulatory strategies are designed to support key development milestones, including IND‑enabling activities, Pre‑IND meetings, and downstream clinical and submission planning.

Gap Analysis

A regulatory gap analysis is important for regulatory strategy and effective product development planning, especially ahead of milestones such as Pre-IND meetings and IND submissions. Uniphar evaluates program readiness to identify regulatory, data, and execution gaps that may impact development timelines.

Regulatory gap analysis services include:

• Assessment of regulatory readiness across development stages
• Identification of data, strategy, and execution gaps
• Clear prioritization of regulatory risks and mitigation strategies
• Translation of findings into actionable, stage-appropriate regulatory plans

Gap analyses are practical and execution‑focused, directly informing regulatory strategy, development planning, and health authority engagement.

Drug and Product Development Planning

For Sponsors who need a clear path from early development through submission, Uniphar provides integrated drug and product development planning that translates regulatory into actionable, cross-functional plans.

We ensure regulatory requirements are embedded into development activities, timelines, and decision points, supporting efficient progression and reducing risk.

• Phase‑appropriate development plans → aligned to FDA expectations
• Milestone planning for key interactions → Pre‑IND, End‑of‑Phase, Pre‑NDA/MAA, Scientific Advice
• Cross‑functional alignment to reduce regulatory risk → clinical, nonclinical, and CMC
• Integration of regulatory strategy → into overall development plans

Regulatory Submissions and Health Authority Engagement

Uniphar provides direct leadership and execution for regulatory submissions and interactions with health authorities worldwide. Our teams work alongside Sponsors to ensure clear and consistent communication with Agencies such as FDA, EMA, and other global regulators.

Regulatory Agency Liaison and Submissions

• Pre‑IND and Scientific Advice meeting planning
• Regulatory submissions and maintenance
• End‑of‑Phase (EOP1, EOP2) and Pre‑NDA/MAA meetings
• IND, NDA, and MAA strategy and regulatory submissions
• Submission maintenance and regulatory lifecycle management
• FDA Advisory Committee briefing package development
• Initial and pediatric study plans

Our teams ensure that regulatory strategy and execution remain aligned throughout development and submission, reducing risk and supporting efficient progression to key regulatory decisions.