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Product Development
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Clinical Trials
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Quality
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GxP Audits
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Regulatory Affairs
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Pre-authorisation
- Regulatory Roadmap
- Scientific Advice
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Product information
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Dossier preparation
- Dossier Gap Analysis
- MA Handling
- Post-authorisation
- Regulatory outsourcing
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Pre-authorisation
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Pharmacovigilance
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QP Service / Importer
PhV system
Pharmacovigilance system outsourcing in the case of SciencePharma is a broad concept that covers many actions that our experts perform for our clients in the field of Pharmacovigilance. If your company has or intends to have products authorised in Poland or other EU countries or even outside the EU you are legally obliged to introduce and maintain a Pharmacovigilance system for your medicinal products. Depending on the specific needs of your company, our cooperation may cover the range of activities that suits you best.
Our services include among others:
- Development and maintenance of pharmacovigilance system master file (PSMF) and MAHs PhV SOPs,
- Pharmacovigilance system implementation, covering preparation of Safety Data Exchange Agreement (SDEA) – we cooperate with our Legal Department in this matter,
- Article 57 (xEVMPD) base management – MAHs are responsible for the suitable maintenance of information in xEVMPD and are obliged to update the database in case of variations, transfers or new authorisations. Fortunately, we can help you with that process. We assist multiple companies in uploading data and updating the XEVMPD database,
- Risk Management Plan (RMP) development and maintenance,
- Pharmacovigilance Regulatory Intelligence.
Our experts can partner with you and assist with all the elements of pharmacovigilance system or just individual part of it – we can tailor the service to match your expectations too.