PharmaFlex24 supports pharmaceutical companies, marketing authorisation holders and international CROs with specialised pharmaceutical and regulatory services.
Our service portfolio includes outsourced responsible-person services, pharmacovigilance, Regulatory Affairs, Quality Management and Medical Services – delivered flexibly, on a project basis or through long-term cooperation.
PharmaFlex24 supports pharmaceutical companies and CROs with selected regulatory responsible-person functions in Germany and Croatia, as well as European PV structures.
Germany
Croatia
Further Functions
Formal appointments are subject to applicable regulatory requirements and qualification assessment.
PharmaFlex24 supports marketing authorisation holders and CROs with local and international pharmacovigilance processes and the structured handling and documentation of safety-related information.
Our services include:
The nature and scope of services are agreed according to the specific project and the pharmacovigilance system of the client.
Marketing authorisation documentation and Regulatory Support
QMS, SOPs and Quality Documentation
GDP- and GVP-compliant processes
Scientific writing and medical documentation
Product information and medical enquiries
Preparation, documentation and CAPA support
PharmaFlex24 supports pharmaceutical companies with regulatory documentation and the establishment and further development of quality-managed processes.
Our services cover Regulatory Affairs, Quality Management and compliance with GVP and GDP requirements.
Our services include:
We support both individual projects and long-term regulatory and quality-related activities.
PharmaFlex24 provides medical and pharmaceutical expert support to pharmaceutical companies, CROs and other life sciences organisations.
We combine pharmaceutical expertise with scientific communication and structured medical documentation.
Our services include:
Our services are agreed according to the scientific and regulatory requirements of each project.
PharmaFlex24 provides pharmaceutical consulting, operational support and selected regulatory responsible-person services. The assumption of a specific function is subject to fulfilment of the applicable legal and regulatory requirements, the required individual qualifications, an appropriate contractual agreement and, where applicable, formal appointment or recognition by the competent authority. Any legal responsibilities that remain with the client are unaffected.
