Company Profile

Sourcing Inquiry

PHATOPHY

Regions
Europe
Countries
France
Size
5-20
Specialty
Human Medicines, Animal Medicines, …
Specialty
Human Medicines, Animal Medicines, Medical Devices
Service category
Pre-clinical development and testing, pre-clinical CRO, Analytical laboratory and testing services, …
Service category
Pre-clinical development and testing, pre-clinical CRO, Analytical laboratory and testing services, Regulatory services - CMC writing - medical writing, Consulting - strategy and development
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Key services

Services

In-life studies (Veterinary preclinical studies)

Palatability tests
Efficacy tests and challenge tests
Pilot and proof of concept studies on target species
Metabolic studies
 

Pharmaceutical analysis :

Development and validation of the appropriate analytical methods applied to your API and finished product
Stability studies
Physical and chemical tests
Microbiological tests (in partnership)
Quality control
 
Bioanalysis
Development and the validation of analytical methods apply to residue depletion studies in injection site and/or in tissues, milk, eggs or to PK studies in blood, plasma, urine,...
 

Consulting / Expertise in pharmaceutical & biological development:

Assistance for defining product specifications
Product development strategy (roadmap)
Drafting of development protocol

Project management:
Manufacturing process, active ingredient and product control definition according to project specifications
Budget definition and monitoring
Time schedule definition and monitoring

 

Regulatory Affairs
writing of export dossiers
Veterinary medicines (Audit evaluation of pharmaceutical dossiers, technical data, Writing of part II, III and IV, Answers to questions of Agencies)
 
Quality Assurance
Independant quality system
GLP acreditation
Audits of critical phases

Approvals, Certificates, Authorisations

  • GLP certication .
  • Research Tax Credit agreement (“Crédit Impôt Recherche / CIR”)

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