November 21, 2024
Experienced auditors with strong background in the audit reference standards. We provide assurance of compliance through a wide range of areas of expertise.
To qualify your suppliers, mitigate risks and identify areas of improvement in your own systems and ensure operations, documents and processes meet the required quality standards.
Clinical & Non-Clinical CTD modules;
Clinical Addendum;
Text preparation and revision (SmPC and PIL);
Readability tests and bridging reports;
Similarity reports.
Preparation and review of promotional and non-promotional materials;
Preparation of abstracts, manuscripts, posters and presentations;
Scientific translations;
Advisory boards and roundtables;
Medical inquiries management.
Toxicological reports;
Environmental Risk Assessment (ERA) reports;
Permitted Daily Exposure (PDE) calculation reports.
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