M.A. LICENSE &

MAINTENANCE

• Synthetic and semi-synthetic drugs

• Biological Products

• Orphan diseases

• Advanced Therapies

• Cannabis products

• Specific drugs

• Health products.

REGULATORY STRATEGY

• Due Diligences

• Gap Analysis

• Regulatory Intelligence

• GMP Audits and inspections

• Road-maps for new businesses

• Scientific advice

• License Hosting and Partnerships

TRAINING AND TRAINING

• Regulatory Strategy

• Analytical Validation

• Process Validation

• Stability and Degradation

• Post-approval variations

• CTD

• Biological Products

• Pharmaceutical Ingredients (APIs)

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In-company and online training.

Coaching for new analysts.

TECHNICAL TRANSLATIONS

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