Due Diligence & In/Out-Licensing Support

Empowering Confident Decisions Through Strategic Evaluation and Data Integrity

Overview

In the pharmaceutical industry, the success of a partnership or licensing agreement depends on accurate data assessment, regulatory readiness, and commercial feasibility.
At North Pharma Consulting, we provide comprehensive due diligence and licensing support to help companies make informed, strategic decisions — whether acquiring, partnering, or out-licensing products.

Our experts conduct scientific, regulatory, and commercial evaluations to ensure data integrity, identify potential risks, and confirm the true market value of your asset before finalizing any agreement.

Key Challenges We Address

  • Unverified data quality and incomplete regulatory documentation
  • Lack of transparency during in/out-licensing negotiations
  • Inconsistent technical information across global submissions
  • Difficulty assessing commercial potential and market positioning
  • Limited internal resources to perform multidisciplinary due diligence

Our Approach

1. Comprehensive Data & Dossier Review

We perform detailed regulatory dossier evaluations (CTD, eCTD, or legacy formats) to confirm data completeness, quality, and compliance with local and international standards.
This includes analytical method validation, CMC documentation, and review of non-clinical and clinical sections.

2. Regulatory and Technical Gap Analysis

Our team identifies any regulatory gaps or inconsistencies that could impact licensing or product launch.
We assess prior regulatory interactions, deficiency histories, and readiness for submission or renewal in target markets.

3. Commercial Viability & Market Fit

Beyond technical review, North Pharma Consulting evaluates each opportunity’s business potential, analyzing competitive landscape, therapeutic relevance, and expected return on investment.
We provide data-driven insights to support negotiation strategy and portfolio alignment.

4. In-Licensing & Out-Licensing Facilitation

We assist in identifying and connecting with suitable partners for in-licensing, out-licensing, manufacturing, or distribution.
Our team facilitates due diligence meetings, document sharing, and communication flow between stakeholders.

5. Risk Mitigation & Strategic Recommendations

After evaluation, we deliver a comprehensive Due Diligence Report outlining all findings, potential risks, and actionable recommendations — ensuring every decision is based on verified, reliable data.

Benefits

  • Reduced financial and regulatory risk before signing agreements
  • Independent, expert validation of data quality and compliance
  • Clear understanding of market positioning and value potential
  • Enhanced negotiation confidence and partner transparency
  • Time-efficient, structured decision-making process

Why Choose North Pharma Consulting

With over 15 years of experience in regulatory affairs and business development, North Pharma Consulting provides the expertise and perspective needed to bridge the gap between science and commerce.
Our integrated approach combines regulatory insight, technical depth, and business intelligence — ensuring that every partnership decision is grounded in evidence and strategic clarity.