On this page you will have an overview of our different services. Find the optimal solution for the specific needs of your company.
Area: EU (EMA) ● US (FDA)
- Regulatory Affairs - Products
- Medicinal Products
- NCE/ Generics ● Biologics/ Biosimilars ● ATMP
- Phytopharmaceuticals ● Homeopathics/Anthroposophics
- Medical Devices
- Medicinal Products
- Regulatory Affairs - Clinical Trial Applications
We offer you
- Interims-Management
Temporary replacement of important employees in the area of Regulatory Affairs ● Support of companies in regard to complex projects or critical business processes ● RA Expert Recruitement - Pre-Approval Support
Development ● Strategic Consulting ● Scientific Advice ● Briefing Package ● Submission Project - Post Approval Support
Life Cycle Management/ Strategy (Line Extension) ● Maintenance (Variations, PSUR/PBRER, Renewal, Sunset Clause Monitoring) - Labelling Support
- Regulatory Intelligence
- Technical Writing
- Medical Writing
- Issue of eCTD-Dossiers
- eSubmission (eCTD, NeeS, CESP, PharmNetBund)
- EU-/ US-Network
Regulatory Affairs Network
Benefit from our expert network. Due to the collaboration of the following companies, we are able to use these synergies for your success.