CMC & Quality (Drug Substance & Drug Product)

Delivering Manufacturing Excellence and Regulatory Confidence

Overview

Quality and consistency are the foundation of every successful regulatory submission.
At North Pharma Consulting, we provide expert support in Chemistry, Manufacturing and Controls (CMC) for both drug substance and drug product, ensuring that your development and manufacturing processes meet international quality standards and regulatory expectations.

Our CMC specialists assist clients in building, reviewing, and optimizing documentation required for CTD Module 3, supporting efficient submissions and lifecycle management across EU, UK, CIS, MENA, LATAM, US, and Asia.

Key Challenges We Address

  • Inconsistent or incomplete CMC documentation across product lines
  • Unclear comparability and process validation strategies
  • Managing global expectations for impurities, stability, and manufacturing changes
  • Adapting to evolving ICH guidelines (Q3D, Q9, Q12)
  • Resource limitations for complex data compilation and submission updates

Our Approach

1. CTD 3.2.S/P Authoring & Review

We prepare and review CTD Module 3.2.S (Drug Substance) and 3.2.P (Drug Product) documentation to ensure accuracy, completeness, and harmonization with quality and regulatory requirements.
Our structured approach helps streamline submissions and minimizes regulatory deficiencies.

2. Process Validation & Comparability Studies

Our team supports process performance qualification (PPQ) and comparability assessments for manufacturing site changes, scale-ups, and post-approval modifications, ensuring regulatory confidence and product consistency.

3. Elemental Impurities & Nitrosamine Control

North Pharma Consulting provides strategic guidance on ICH Q3D elemental impurity assessments and nitrosamine risk evaluation, including mitigation strategies, analytical justifications, and control plans.

4. Stability Studies & Quality Risk Management

We design and evaluate stability studies according to ICH Q1 requirements, covering shelf-life extensions, packaging changes, and storage conditions.
We integrate ICH Q9 Quality Risk Management principles to ensure data-driven, compliant decisions.

5. CMC Change Control & Lifecycle Support

We help implement ICH Q12-aligned change control systems to manage CMC updates, manufacturing changes, and product improvements efficiently across multiple regions.

Benefits

  • Complete and compliant CMC documentation ready for submission
  • Reduced risk of regulatory deficiencies and delays
  • Science-based validation and comparability justification
  • Stronger quality and manufacturing consistency across sites
  • Predictable change implementation following ICH Q guidelines

Why Choose North Pharma Consulting

With extensive hands-on experience in drug substance and drug product development, North Pharma Consulting brings together technical expertise and regulatory insight to ensure your CMC documentation meets the highest standards of quality and compliance.
We support clients in achieving regulatory readiness, manufacturing reliability, and lifecycle sustainability.