Regulatory Strategy & Intelligence

Building Smart Pathways to Global Market Access

Overview

In an increasingly complex regulatory landscape, a well-defined strategy is key to bringing your product to market efficiently and sustainably.
North Pharma Consulting develops tailored regulatory roadmaps that align with your product’s profile, target regions, and business objectives.

We help pharmaceutical and biotech companies anticipate challenges, identify optimal regulatory routes, and engage effectively with health authorities to ensure timely approvals and ongoing compliance across global markets — including the EU, UK, CIS, MENA, LATAM, and Asia.

Key Challenges We Address

  • Fragmented and evolving regional regulations
  • Limited internal resources for multi-country submissions
  • Unclear pathway selection for innovative or borderline products
  • High cost and delays due to incomplete regulatory planning
  • Coordination of global regulatory intelligence and updates

Our Approach

Our experts combine deep technical expertise with strategic insight to design a custom regulatory roadmap that minimizes risk and accelerates market access.

1. Regulatory Intelligence & Gap Analysis

We continuously monitor evolving guidelines and requirements from EMA, MHRA, FDA, TGA, HC, GCC, and WHO PQ programs.
Through a detailed gap analysis, we identify missing data, documentation gaps, and optimization opportunities in your existing dossiers.

2. Pathway Assessment & Strategic Planning

Based on product type and target market, we recommend the most suitable approval pathway — whether centralized, decentralized, mutual recognition, or national.
We also evaluate special regulatory designations such as PRIME, Breakthrough Therapy, Orphan Drug, Paediatric Investigation Plan (PIP), and SME status.

3. Scientific Advice Coordination

We support you in obtaining agency feedback at the right development stage to de-risk submissions.
This includes:

  • Preparing and submitting advice request packages
  • Selecting the most appropriate European authority
  • Managing agency meetings and oral explanations

4. Documentation & Regulatory Roadmap

We provide a clear, step-by-step plan detailing submission timelines, required documents, and authority expectations for each target market.
This roadmap becomes your actionable framework for global product development and registration.

Benefits

  • Reduced time-to-market through proactive planning
  • Early identification of risks and data gaps
  • Clear communication strategy with regulatory agencies
  • Optimized submission packages aligned with regional expectations
  • Streamlined approval and lifecycle management

Why Choose North Pharma Consulting

Our team of experienced regulatory strategists, pharmacists, and scientific advisors has over 15 years of cross-regional experience managing submissions and approvals worldwide.
We work closely with clients to ensure clarity, predictability, and confidence in every regulatory step — from development to post-approval.