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We offer highly specialised regulatory services and solutions to cater to the needs innovative pharma and biotechs ranging from start-ups to large global companies. The health authority consultations include scientific advice and FDA meetings.
Scientific Advice
Paediatric Investigation Plans
Orphan Designations
Community Referrals
Clinical and nonclinical overviews and summaries
Early access medicines/compassionate use programmes
Orphan Designations
Paediatric Investigation Plans (PIPs)
Centralised
Decentralised
Mutual Recognition procedures
CHMP, PRAC and CMD(h) referrals
Small, Medium Enterprise (SME) status
Scientific advice
Clinical trial applications
Nvestigator Brochures
Clinical Trials Protocols
Clinical Study Reports
PSURs, PBRERS
NICE and reimbursement support documents
SmPC and PIL labelling reviews
EU Regulatory Strategy
Clinical Trial Application –
EU CTR
Medical Writing for
Protocols
Scientific Advice and Pre
submission Meetings
Marketing Authorisation Applications
Post Marketing and Lifecycle Management
Paediatric Applications
Orphan Drug Designations
UK Regulatory Strategy
Clinical Development
Innovation Passport
Marketing Authorisations
Post Marketing and Management
Paediatrics
US Regulatory Strategy
IND
NDA/BLA
Post NDA/BLA Lifecycle
Paediatrics
Rare Disease
Your innovative regulatory services and solutions partner.
