04 / Strategy and filings, full lifecycle
Regulatory Affairs
Strategic and hands-on regulatory support across the full lifecycle. We help you navigate complex global requirements with clarity and confidence, and get submissions right the first time.
Regulatory strategy for US FDA, Health Canada and EMA
IND, CTA, ANDA, NDA and MAA support
eCTD filing for the US and EU
Labelling, lifecycle management and post-approval
Gap assessment and remediation
Regulatory CMC gap assessment and remediation
Product dossier gap assessment and resolution pathways
Practical, risk-based solutions aligned to business objectives
Have a program that needs regulatory affairs support? Tell us where it stands.
Credible partners for pharmaceutical & life-sciences clients. Evidence-led advisory in CMC, regulatory, quality and strategy for NCEs, generics and branded-generics.
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