regulatory affairs
Build upon a strong and smart Regulatory Affairs strategy, products can be registered fast and held in the market with low-efforts in regards to surveillance/vigilance.
Our Regulatory Affairs Manager
Pragmatic approach to regulations and regulatory strategies
Goal oriented
Interdisciplinary working habit
Excellent netowrkers in teh field of regulations
Team oriented, friendly and outgoing
CAS or higher in Regulatory Affairs
RAC
TOPRA
Experts working with Avanti Europe have all a proven track record of significant and relevant academic and industry experience. On average, industry experience of more than 20 years per expert is available.
All experts undergo regular continuous education to keep the knowledge at the edge of the industry.
Regulatory affairs manager Have worked on:
-
IDEATION
- Smart Content Management platform for LifeScience company
- Novel phytopharmaceutical product
- Novel food product
- Connected drug delivery device concept
- Data-driven patient outcome concept
- Technical Due Diligence
-
Development
- Novel Food product with supplementary character
- Connected drug delivery system
- Inhalation device
- Dental product
-
Industrialization
- Drug-eluting implant
- Sterile medical device
- Pre-filled syringe
- Auto-injector
- Sterile container
- Manual injector
- Phytopharmaceutical
-
Launch
- Drug-eluting implant
- Sterile medical device
- Pre-filled syringe
- Auto-injector
- Cosmetic
-
market support
- Drug-eluting implant
- Sterile medical device
- Pre-filled syringe
- Phytopharmaceutical
- Cosmetic
regulatory affairs Manager can offer:
On-demand Service
Regulatory affairs expert knowledge at your demand. Based on your needs and interwoven with your existing processes and procedures, we deliver bespoke service.
Book on-demand and we deliver according to the work package defined. This is best used for new product development support, unclear requirements and other projects at a very early stage.
Fixed-price contract
You would like to stay on the save side with the costs? No problem with that, we can deliver the defined work package as a fixed-price contract.
Fixed-price contracts work best with clearly defined work orders, such as regulatory strategies, clinical evaluation reports (CER), yearly reportings (APQR or PSUR), gap assessments in case of regulation changes and updates or many more well defined projects.
