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M.A. LICENSE &

MAINTENANCE

  • Synthetic and semi-synthetic drugs

  • Biological Products

  • Orphan diseases

  • Advanced Therapies

  • Cannabis products

  • Specific drugs

  • Health products.

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REGULATORY STRATEGY

  • Due Diligences

  • Gap Analysis

  • Regulatory Intelligence

  • GMP Audits and inspections

  • Road-maps for new businesses

  • Scientific advice

  • License Hosting and Partnerships

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TRAINING AND TRAINING

  • Regulatory Strategy

  • Analytical Validation

  • Process Validation

  • Stability and Degradation

  • Post-approval variations

  • CTD

  • Biological Products

  • Pharmaceutical Ingredients (APIs)

In-company and online training.

Coaching for new analysts.

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TECHNICAL TRANSLATIONS

  • Technical document translations made by highly trained professionals and reviewed by our team of consultants.