Product Registration & Licensing Assistance

From Development to Market – Guiding Every Step Toward Approval

Overview

At North Pharma Consulting, we support pharmaceutical and biotech companies throughout the entire product registration lifecycle — from the development phase to post-approval maintenance.
Our mission is to ensure that your medicinal product meets all regulatory, technical, and procedural requirements in each target region, enabling a seamless and efficient entry to market.

We act as your dedicated regulatory partner, coordinating with health authorities, notified bodies, and local affiliates to guarantee compliance and accelerate approvals across EU, UK, CIS, MENA, LATAM, and Asia.

Key Challenges We Address

  • Complex documentation and data requirements across multiple markets
  • Misalignment between R&D, regulatory, and commercial timelines
  • Limited internal expertise in multi-region registration processes
  • Extended approval timelines due to incomplete or inconsistent submissions
  • Need for synchronized communication with multiple local authorities

Our Approach

1. Regulatory Pathway & Pre-Submission Planning

We begin by defining the optimal regulatory route for your product — centralized, decentralized, mutual recognition, or national procedure.
Our experts coordinate agency meetings and scientific advice sessions to clarify data expectations and reduce regulatory risk before submission.

2. Dossier Compilation & Registration Filing

We assist with CTD dossier preparation, eCTD publishing, and submission to relevant agencies.
North Pharma Consulting ensures that all technical documentation (quality, non-clinical, and clinical data) is compliant, harmonized, and ready for timely review.

3. Communication with Health Authorities

Our team acts as the primary contact point between your organization and the competent authorities.
We handle all queries, deficiency letters, and post-submission requests, ensuring a coordinated and professional response that maintains submission integrity.

4. Post-Approval Support & License Maintenance

After registration approval, we continue to support your product through renewals, variations, and transfer of marketing authorizations, ensuring continuous compliance and uninterrupted market presence.

Benefits

  • Efficient coordination from pre-submission to post-approval
  • Improved approval timelines through proactive planning
  • Consistent regulatory communication across multiple markets
  • Reduced administrative workload for your internal team
  • Stronger compliance and lower regulatory risk

Why Choose North Pharma Consulting

Our consultants combine scientific expertise with regulatory insight, offering a comprehensive understanding of both global and regional market requirements.
With proven experience in multi-country submissions and agency coordination, North Pharma Consulting ensures that your product registration process is transparent, predictable, and successful from start to finish.