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Preparation, compilation, coordination and monitoring of national and
European registration approvals
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Variation submissions and
notifications
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Product Life Cycle Management
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Annual product profile update (SmPC, PIL)
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Compilation of registration dossiers
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Quality Overall Summary, Nonclinical, Clinical Overview and Summaries
(CTD)
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Compilation and revision of labeling
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Pharmacovigilance
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Maintenance of governm. contacts and contacts to key accounts in the health care system (EMEA,
AGES)
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Registration status evaluation
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We further offer our clients multinational representation of the Regulatory
Affairs department at meetings, conferences, congresses, etc.
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Consulting services regarding all novel guidelines on pediatric trials.
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Consulting services for herbal drugs, orphan drugs, medicinal devices,
diagnostics and vaccines.
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Training
in all issues of Regulatory Affairs
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Preparation of expert statements for the health authorities (AGES).