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| Regulatory and pharmacovigilance issues |
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| 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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