| Assistance and advice with Regulatory Services including: |
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Preparation of applications for Marketing Authorisations for medicinal products in the European Union.
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Comparison of the Summary of Product Characteristics (SmPCs) of the originator products in target markets to identify all areas of potential contention between the Health Authorities in the markets of choice.
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Compilation of SPC/Leaflet and Mock ups.
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Readability Testing and review of the package leaflet.
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Regulation Strategy including advice on individual country requirements to ensure rapid and successful authorisation of dossiers. |
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Translations.
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Licensing of Medicinal products via the National, MRP or DCP procedures.
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Management of applications.
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Submission and management of variations.
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Submission and management of Renewals.
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Preparation of pharmcovigilance system including preparation and compilation of all necessary SOPs.
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Preparation of PSURs. |
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Preparation of Environmental Risk Assessment reports. |
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Assistance with QA Issues including:
Auditing of third party manufacturers, packers and API suppliers.
Strategic advice with regard to finding the perfect partners.
QP release services. |
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