top of page
841bcf43-ee76-445f-a51b-12b08ea13142_edi

Consulting Services

unique_edited_edited.jpg

Special Designations/Programs

  • Orphan Drug Designation [ODD]

  • EMA Priority Medicines [PRIME]

  • Breakthrough Designation [BTD]

  • Regenerative Medicine Advanced Therapy [RMAT]

  • Fast Track Designation

  • Accelerated Approval

istockphoto-1343389492-612x612_edited.jp

Regulatory Management

  • Interim head of regulatory

  • Team expansion and management

  • Advice on Regulatory Operations and Regulatory CMC

  • Regulatory systems, infrastructure, Quality Systems

istockphoto-1067173124-612x612_edited.jp

Health Authority Interactions

  • Support for global Health Authority meetings and scientifc advice

  • Milestone meetings (pre-IND, end-of-Phase, pre-NDA/BLA)

  • Briefing documents

  • Meeting preparation

  • View Health Authority meeting experience

EDT_2025-2487_Milestone_mapping3_edited.

Milestone Submissions

  • Initial IND

  • Pediatric Study Plan [PSP] and Paediatric Investigational Plan [PIP]

  • NDA/BLA/MAA

depositphotos_47641471-stock-illustratio

Regulatory Strategy

  • Regulatory risk assessment

  • Novel endpoints strategy

  • Due diligence

  • Global regulatory lead

Routine_edited.jpg

Routine Submissions

  • Global CTAs and amendments

  • DSURs/Annual Reports

  • CMC amendments

  • Nonclinical study reports

  • Investigator's Brochures

  • Investigator updates

Get in Touch

Julia Clive

President, Principal Consultant

 

Julia.Clive@SovaReg.com

sova owl-no bg_edited.png

Thanks for submitting!

bottom of page