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Our knowledgeable staff produce high quality
documentation. We will ensure that your documents comply with
quality assurance processes and meet required inspection standards.
| We offer: |
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Document production, including
periodic safety update reports (PSURs), annual safety reports,
risk management plans and product labelling |
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Process optimisation for in-house document
production. |
| Recent projects: |
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Standardisation of product
labelling across different countries for a portfolio
of mature products |
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EU-risk management plans (RMPs), risk
evaluation and mitigation strategies (REMS) and risk
minimisation action plans (RiskMAPs) for a variety of
products across many therapeutic areas. |
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