2. Characterization of solid state

• Polymorphism :
  • Identification and characterization of polymorphic form (s) for drug substance (DS) or drug product (DP)
  • Résolution de crystal structure

• Check of the API crystalline structure and / or excipients in the pharmaceutical compounds by confocal microscopy

• Study of the shape and size of particles :- Electron microscopy (SEM-TEM)- Laser granulometry

3. Compatibility studies

• Drug - drug compatibility study
• Drug - excipient compatibility testing

4. Nouveaux services

• Determination as primary standards and secondary quantitative NMR
• Caractérisation - Analyse de milieux complexes / Identification d'impuretés complexes
• Roller compaction (Ruban) : Mesures de Densité d'enveloppe (Fraction solide - Porosité)

We can give you some advice in your strategy of pharmaceutical development with our scientific and pharmaceutical experts :

Scientific and regulatory advice in pharmaceutical development (CMC)

• Strategies for physico-chemical properties of PA, excipients and PF
• Developing analytical methods for search and identification of impurities (including genotoxic impurities)
• Setting up of the corresponding specifications for the PA and PF
• Setting up of chemical and physical stability studies for PA / PF
• Advice in the way to answer questions raised by regulatory agencies (EMEA, FDA...)

advice in preparation of the scientific content of CTD and DMF including during clinical phases (IND and IMPD).

Innovation :

The service call conference.

Call us at 04 34 00 47 85

or fill out the contact form and we will call you as soon as possible.

Call conference = important advice to decrease time and cost of the development strategy of your molecules
 

Physical and physico-chemical characterization of solid state - Review of analytical methods.
 
Polymorphism and its consequences (stability of drug substance and drug product - feasibility of drug product - bioavaibility...)
 
Training on the scientific content of the CTD.