Regulatory Affairs
- Writing, Preparation and Submission of Drug Registration Dossiers
- Life-cycle management of medicinal products, updates, variations,
extensions and renewals of Marketing Authorisations for nationally
authorized procedures, MRP/DCP as well as CP
- Compilation of EU CTD dossiers, including preparation of NeeS and eCTD
- Regulatory Gap Analysis and Due Diligence Checks of registration
dossiers (e.g. prior to license transfer)
- Medical and Scientific Translations
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- Strategic Regulatory Advice, Interpretation of guidelines
and regulatory requirements
- Scientific Advice, Expert Reports and scientific review
- Health Authority Liaison & follow-up of deficiency letters
from Health Authorities
- SOP writing
- Medical Devices & Food Supplements
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Pharmacovigilance
- Writing and Compilation of Periodic Safety Update Reports (PSURs),
Risk Management Plans (RMPs), Detailed Description
of the Pharmacovigilance System (DDPS), Pharmacovigilance
System Master File (PSMF), including data review
- Adverse Drug Reaction (ADR) assessment and coding
- Safety database Management
- Pharmacovigilance audits (from protocol to CAPA plan)
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- Pharmacovigilance Trainings
- Implementation and maintenance of local safety processes,
including SOP writing
- QPPV Services (Qualified Person for Pharmacovigilance)
- Health Authority Liaison & follow-up of deficiency letters
from Health Authorities
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