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)
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.