Scientific Advice & Agency Interaction

Empowering Regulatory Success Through Early Dialogue with Authorities

Overview

Early and well-prepared engagement with regulatory authorities is critical for a successful product development and market approval strategy.
At North Pharma Consulting, we help clients obtain scientific advice from the most relevant agencies — such as EMA, MHRA, FDA, TGA, HC, and national authorities — ensuring that every regulatory decision is informed, strategic, and aligned with current expectations.

Our team provides full support throughout the entire process: from preparing background documentation and formulating questions, to attending meetings and managing post-advice communication.

Key Challenges We Address

  • Unclear regulatory expectations for novel or borderline products
  • Misinterpretation of agency requirements during product development
  • Lack of structured communication with multiple health authorities
  • Missed opportunities to optimize development plans before submission
  • High resource demand for organizing and managing advice procedures

Our Approach

1. Strategic Planning of Scientific Advice

We identify the optimal timing, scope, and agency for your advice request, ensuring that it fits within your development milestones.
Our consultants prepare a scientific rationale and list of key regulatory questions that will maximize the value of agency feedback.

2. Dossier & Question Preparation

We support the preparation of the briefing package, including summaries of quality, non-clinical, and clinical data.
All questions are framed to obtain clear, actionable guidance that reduces regulatory uncertainty.

3. Submission & Meeting Management

North Pharma Consulting coordinates the full submission process and manages communication with the selected agency.
We assist with scheduling, documentation, and participation in teleconferences, written procedures, or oral explanations during meetings.

4. Post-Advice Follow-Up & Implementation

Following receipt of advice, we provide a detailed summary report and interpretation, outlining implications for your development plan and next regulatory steps.
We can also assist in incorporating the advice into your ongoing or future submissions.

Benefits

  • Improved regulatory predictability and reduced development risk
  • Early identification of data requirements and study needs
  • Strengthened relationships with key health authorities
  • Clear strategy aligned with agency expectations
  • Shorter timelines to submission and approval

Why Choose North Pharma Consulting

With over 15 years of experience supporting pharmaceutical and biotech companies in agency interactions, North Pharma Consulting combines scientific depth with regulatory insight.
Our consultants act as your trusted partners, ensuring your voice is clearly represented and your regulatory positioning is optimized from the start.