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Regulatory and pharmacovigilance issues
Regulatory and pharmacovigilance issues
The services provided by P-Value Medical regarding this issues are:
- Creation of Pharmacovigilance planning
- Definition of the type of product regarding regulatory requirements (Health Products, medicines, cell drugs…)
- Definition of the process for registration.
- Development plan (quality, preclinical and clinical) following current legislation requirements (including guidelines)
- Supervision of quality guidelines compliance in the different development phases (procedures of correct manufacture, Good Laboratory Practice…)
- Authorizations for pharmaceutical laboratory
- Scientific Advice
- Monitoring of relevant Authorizations
- Implementation of Quality Systems and Management Systems of R+D (including rules of the serial UNE 166.00x)
- Policies and strategies definitions of R+D (including advertisement)
 
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