Regulatory strategy development
IMPD development / review
Label text development / review
Procurement of clinical trial liability insurance
Providing legal representative services for non-EU customers
Collection and review of regulatory documents
Compilation of dossiers for CTAs to ECs and CAs
Management of submission processes
Investigational Product (IP) Release - IPR form
Regulatory Management of entire lifecycle of a clinical trial including international and local regulatory requirements compliance
Investigational New Drug Application
New Drug Approval
Clinical Trials strategic planning and submission
SEC
Regulatory correspondence
