Regulatory Services We provide a variety of plug-and-play regulatory services and solutions catering to the needs of our innovative drug development partners. Health Authority Consultations Paediatric Orphan/Rare disease Designations Community ReferralsClinical and nonclinical Overviews and summaries Early access medicines/compassionate use programmes Patient Advocacy Regulatory/Medical Writing Scientific Advice and Health Authority Interactions Paediatric Investigation Development Plans -PIP/PSP Orphan/Rare Disease Designations IVDR/cDX EU-CTR Special Protocol Assistance CTA/IND MAA/NDA/BLA MHRA Innovative Passport Post Approval/Life Cycle Management Label and Safety Updated Quality/RegCMC Regulatory Writing and Reviews (Protocols, IBs and ICFs) Clinical and Non¬clinical Overviews and Summaries Early Access Medicines/Compassionate Use programmes Clinical Trial Disclosure/Transparency Redaction Services EU Policy 43: Access to Document Requests Community Referrals
