Cenvia was founded by senior industry operators with more than three decades of hands-on experience across pharmaceutical and medtech organisations in Asia and Europe.
We have spent our careers leading clinical development, regulatory affairs, quality, access, and commercialization - working directly with global health authorities and guiding assets through approval and scale.
Having built and run these functions from the inside, we understand the practical realities companies face as they grow across regions: what regulators expect, what partners require, and what internal teams need to execute confidently.
We created Cenvia to bring this level of senior, cross‑border leadership to organizations that are scaling -without the overhead or junior leverage models of traditional consulting.
We provide consulting in three primary modes:
- strategic advisory for high-impact decisions at critical inflection points,
- fractional leadership (serving as acting Head of Clinical, Quality, Regulatory, or Business Development)
- mid- to long-term program build and execution, where we design and implement global-ready regulatory and quality infrastructure while working directly with executive, technical, operational teams, and investors—without a junior leverage model or generic frameworks.
We are engaged to:
•Design cross-border clinical, regulatory, quality & market access strategy for assets and devices moving between Asia, Europe, America, and MENA
•Align global development pathways to prevent rework and reduce delays
•Prepare companies and assets for licensing, investment, or commercialization
•Act as fractional senior leadership when companies scale faster than they can hire.
• Small & Large Molecules
• Advanced Therapeutics (ATMPs)
• Vaccines
• Radiotherapeutics
• Combination Products
• Medtech
• In-Vitro Diagnostics
• Digital Health
• Oncology
• Immunology & Autoimmune Disorders
• Hematology
• Cardiovascular
• Metabolic Disorders
• CNS & Neurodegeneration
• Infectious Diseases
• Rare Diseases
• Mental Health
• Women’s Health
• Longevity
• (pre-) Investigational New Drug (IND)/Clinical Trial Application (CTA)
• (pre-) New Drug Application (NDA)
• Biologics License Application (BLA)
• Abbreviated New Drug Application (ANDA)
• Marketing Authorisation Application (MAA)
• Pre-Market Notifications & Approvals (Device & IVD)
• De NoVo / Innovative Route Classifications
• Post‑approval & change‑management submissions
No — we work with companies of all sizes, from startups to global enterprises. Our solutions are flexible and are tailored to meet your unique business needs, size and maturity level.
