ServiceUpdated on 17 August 2025
Regulatory Affairs Services
About
The main Regulatory Affairs services areas include:
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Early development
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Regulatory strategy
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CMC strategy
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Development plan
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Due diligence
 
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Pre-registration activities
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CTA/IND/ODD&PIP
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Scientific advice
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MAA strategy
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Pre-submission meeting
 
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Registration activities
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Full MAA/NDA support
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Dossier preparation and submission
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Liaison with authorities
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Project management
 
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Post-approval support
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Product launch
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Lifecycle management
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Regulatory compliance
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Regulatory intelligence
 
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Type
- Consulting
 - Others
 
Applies to
- Development stages and support fuctions - Clinical research and development
 - Development stages and support fuctions - Regulatory and compliance
 
Organisation
Similar opportunities
Service
Medical Devices & IVDs & Combination Products Services
- Others
 - Consulting
 - Development stages and support fuctions - Regulatory and compliance
 - Development stages and support fuctions - Technology development and validation
 
Jane Müller
Head Legal, Business Development representative at Luminance Health
Basel, Switzerland
Service
- Consulting
 - Development
 - Innovative therapies - Gene therapy
 - Innovative therapies - Stem cell therapy
 - Innovative therapies - Oncolytic viruses
 - Innovative therapies - Immune cell therapy
 - Innovative therapies - Somatic cell therapy
 - Development stages and support fuctions - Data management and analytics
 - Development stages and support fuctions - Contract research (CRO / CRMO)
 - Development stages and support fuctions - Clinical research and development
 - Development stages and support fuctions - Development and (GMP) manufacturing
 - Development stages and support fuctions - Pre-clinical research and development
 - Development stages and support fuctions - Commercial strategy and market access
 
daniel lüscher
CEO at QBDC GmbH
Nusshof, Switzerland
Service
- Others
 - Consulting
 - Development stages and support fuctions - Regulatory and compliance
 - Development stages and support fuctions - Clinical research and development
 
Jane Müller
Head Legal, Business Development representative at Luminance Health
Basel, Switzerland