Pharmaceutical Consulting for
Development & CMC Strategy
Get a Strategic Expertise for your
High-Value Pharmaceutical Projects
Areas of Expertise
Comprehensive support across Drug Pharmaceutical Development
Pharmaceutical Development & CMC
- Design and optimization of complex formulations
- Coordination of analytical and process development
- Implementation and documentation of QbD, stability programs, and scale-up
- Support for writing and revising CMC dossiers (3.2.S / 3.2.P) for FDA/EMA submissions (ANDA, 505(b)(2), hybrid applications)
- Support for the preparation of technical documentation for R&D tax credit claims
CDMO Support & Industrial Operations
- Selection and evaluation of technical partnerships (EU, India, North America)
- Execution of technical audits, CAPA plans, and continuous improvement initiatives
- Drug lifecycle extension: strategic assessment of product portfolios
- Optimization of existing formulations and development of value-added versions
Leadership & R&D Team Structuring
- Diagnostic of R&D team dynamics and performance drivers
- Structuring new scientific departments (Formulation, Analytical Development, Tech Transfer, CMC)
- Supporting managers in developing technical leadership, communication, and cross-functional collaboration
- Implementing a culture of accountability and agile project management across R&D, Quality, Regulatory, and Manufacturing
The success of a biopharmaceutical project depends as much on human dynamics as on scientific excellence.
"Combining scientific rigor, strategic clarity, and operational excellence."
360° Vision
Complete pharmaceutical lifecycle perspective, from concept to market
Proven Leadership
International experience managing multi-site, cross-functional programs
Technico-regulatory Excellence
Strong execution capability within highly regulated environments
(FDA, EMA, Health Canada)
Transformational Outcomes
Leadership focused on innovation, efficiency, results, and team engagement
Who We Work With
Trusted partner for pharmaceutical organizations at every stage
CDMOs / CMOs
Seeking to strengthen their development or CMC capabilities
Pharmaceutical & Biotech Companies
Developing complex or high-technology products
Investors & Funds
Requiring independent technical due diligence
Small & Mid-Size Pharma
Organizations undergoing growth or regulatory certification
Collaboration Approach
A structured, transparent 4-step process designed to deliver measurable impact
Strategic Assessment
In-depth analysis of your context, challenges, and objectives
Clear Roadmap
Prioritized, measurable action plan tailored to your needs
Collaborative Execution
Transparent partnership with focus on scientific rigor and trust
Tangible Results
Measurable, actionable outcomes that empower your teams
Built on Core Values
Let's Discuss Your Needs
An initial consultation helps define your challenges and identify high-impact opportunities for your organization.
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Mary Page
Based in Montreal
Available remotely & on-site
Canada & International
100% Confidential
Your information is confidential. Initial consultations are obligation-free and designed to help you make informed decisions about your pharmaceutical development needs.