With flexible GMP facilities and experienced teams, we support API commercialization through optimized process demonstrations and validation batches, ensuring successful regulatory submissions.

Our services

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End-to-end process validation and CMC support

Our integrated approach combines process chemistry, analytical sciences, and regulatory expertise to de-risk your program and accelerate approvals.

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Core process validation capabilities

  • Design and execution of process validation (PPQ) batches
  • Process performance qualification aligned with regulatory expectations
  • Development of control strategies and critical process parameter (CPP) studies
  • Design of Experiments (DoE) and process mapping
  • Spike, fate and purge studies
  • Technology transfer to internal or external manufacturing sites
  • Commercial manufacturing support and re-supply (from gram scale to >100 kg per batch)
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Advanced purity control & risk mitigation

We provide comprehensive impurity control strategies from early development to commercial stages, ensuring compliance with global regulatory guidelines.

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Impurity identification & control

  • Identification, isolation, and synthesis of process-related impurities
  • Spike, fate and purge studies
  • Control strategies for organic, inorganic, genotoxic impurities, and nitrosamines
  • Analytical reference standard qualification 
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CMC gap analysis & quality risk assessment

We provide comprehensive CMC gap analysis to identify risks and ensure readiness for regulatory submission and commercialization.

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Key deliverables

  • CMC documentation review and gap identification
  • Quality risk assessments aligned with ICH and QbD principles
  • Fate and purge study integration into control strategies
  • Recommendations for process, analytical, and regulatory improvements
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Quality and regulatory excellence

Our experienced quality teams work collaboratively with clients throughout the project lifecycle to ensure phase-appropriate compliance.

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Our expertise

  • Support from IND to NDA and commercial launch
  • Alignment with FDA, EMA, and global regulatory expectations
  • Continuous CMC support during and post-commercialization
  • Inspection-ready documentation and validation packages