Regulatory medical devices
Medical devices regulations in Europe differ from regulations for medicinal products…
Consulting
As a full service clinical CSO, we are familiar with all aspects of clinical development and regulatory affairs of drugs and medical devices. Our consulting services cover the whole product life-cycle; from development over marketing authorization and life-cycle management to withdrawal of the product from the market.
Clinical consulting:
- Development planning
- Development of study design, protocol
- Sample size calculation
- Statistical consulting
- Clinical sites and investigators database
- Study placement and patient population availability
- Development cost estimates
Regulatory Consulting:
- Development of regulatory strategy
- Marketing authorization applications
- Liaison with regulatory authorities, preparation of pre-submission meetings, preparation briefing packages and application forms,
- Orphan drug applications with EMA and FDA
- Variations of existing marketing authorizations, European type IA/IB, II, notifications
- Renewals and extensions
- Centralized procedures, abbreviated procedures
- CMC writing, update of quality dossier, CTD module 3
- Advice for Advanced Therapeutics Medicinal Products (ATMP) procedures
- Regulatory evaluations for medical device, combination or borderline products
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Orphan drug and pediatric procedures
The designation of an orphan drug is a challenging process….
Document management
We can help our clients set up and configure their document management system, tailor…
Clinical trial authorizations Europe
Appletree CI Group offers clinical trial authorization services all over Europe…
Legal representation Switzerland and EU
According to the regulations, Sponsors without legal residence in the EU or Switzerla…
QA/QC
Our quality assurance and quality control processes ensure adherence of our operation…
