AzurBio Consulting
Guiding Life Sciences Companies
Through European Regulatory Challenges
With 30 years of expertise, we partner with life sciences companies to develop and launch innovative products while ensuring regulatory compliance.
Our approach combines hands-on regulatory experience, and a deep understanding of industry needs to deliver personalized support at every stage of product development, registration, and commercialization.
We partner with life sciences companies developing healthcare products, guiding them through every stage of the development process up to the registration phase.
We also support clients in maintaining regulatory compliance during the commercialization of their products across Europe.
Development
Regulatory strategy & Roadmap
Health Authority meetings
EMA or EMA/HTA Scientific Advice
Chemistry, Manufacturing and Controls (CMC) solutions
Orphan Drug Designation (ODD)
Paediatric Investigation Plan (PIP)
IB and IMPD writing
ASMF, DMF and CEP writing
Advanced Therapy (ATMP)
Gap analysis/Due diligence
PRIME (priority medicines) scheme
Registration
EU Registration Strategy
CTD Writing
Management of Registration procedure
Product information and Labelling
Commercialization and Life Cycle Management
Variations, renewals and MA transfer
Promotional material review & Sign Off
Compliance with Healthcare Professionals
Quality System and Audit
Exploitant status for France
Launch readiness & strategy
Early Access Programme (EAP)
EAP Application Writing
Management of EAP Authorisation procedures
Exploitant services for France
Management of EAP programmes in Europe
Medical Devices
Development – Regulatory positioning & product development support
Regulatory & Registration – Technical documentation (MDR 2017/745) & CE marking
Post-Market Compliance – Documentation updates, Change management & Promotional material compliance
CE Marking Strategy & European market entry
Specialised Services
SME representation or SME registration support
Quality Management System (QMS), SOP Development & Audit (GMP, GDP, ISO 13485, ISO 22716)
At AzurBio Consulting, our team brings decades of regulatory expertise and a proactive approach to problem-solving.
With deep industry knowledge in pharmaceutical and healthcare products, we guide life sciences companies through product development, registration, and market launch, delivering tailored solutions to navigate regulatory challenges and ensure success.
Paris (Headquarter)
Nice
Zug
Boston
New York
Proven Track Record
A history of delivering successful outcomes, consistently meeting client expectations, and navigating complex challenges with excellence
Elite Team
- Committed to investing resources to bring the best talent on board
- Upholding high hiring standards with a focus on expertise
- Cultivating a supportive environment to nurture and grow talent
Strong Strategic Partner Network
Leveraging a network of experts enhances our team’s efficiency by matching the right skills to specific needs, enabling quick adaptation to challenges with precision and expertise.
Looking to establish and bring your 1st
life-changing medicine across Europe?
