Investor Presentaiton
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Start here - stay here
Be the preferred partner across the entire peptide value chain
Drug discovery & lead
optimization
API development & manufacturing: From early phases to commercialization
Clinical development
Pre-clinical research
Phase I
Phase II
Phase III
NDA filing
GMP clinical batches
Drug product launch
Commercialisation
Generization
API manufacturing
Non-GMP batches
Scale-up batches
Commercial supply
PPQ batches
API process & analytical
development
Process development
Analytical method development
Process validation
Analytical method validation
Product release & LCM
Developmental stability studies and ICH stability
Annual product review
Regulatory support
& documentation
CMC documentation and filing support
API - Active pharmaceutical ingredient; CMC - Chemistry, manufacturing & controls; GMP - Good manufacturing practice; ICH - International council for harmonization; LCM - Life cycle management; NDA - New drug application; PPQ - Process performance qualification
GLOBAL SUPPORT FOR A QUALITY SOLUTION
13
Post approval changes
PolyPeptide
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