With extensive experience in drug development, Chemistry, Manufacturing and Controls (CMC), and operational leadership, we support biotech and life science companies in advancing promising assets through critical development milestones.
We help transform scientific potential into robust development and commercialisation programmes while reducing technical, regulatory, and execution risk.
Specialised Capabilities
Transforming Biotech Challenges into Strategic Advantages
[01]
Programme Assessment
[02]
Technical, Quality & CMC Leadership
[03]
C-Suite Enhancement
Independent evaluation of development programmes (timelines, budgets, risk assessments) to support internal decision-making, partnering discussions, and investment diligence.
Expert oversight of contract development and manufacturing organisations (CDMOs) and quality activities, ensuring development programmes are technically robust, phase appropiate, compliant and positioned for successful clinical and commercial progression.
Strategic guidance on lean development pathways with capital efficiency from discovery through First-in-Human (FiH) and operational scale-out for subsequent clinical development.
Quality Management System (QMS)
Developing pragmatic solutions tailored to the needs of emerging and growing biotech organisations
Established the QMS and supporting infrastructure to ensure product development activities are conducted in accordance with company policies, SOPs, and applicable regulatory requirements in the Sponsor role
Small Molecules (early-stage)
Leveraging C-suite experience and deep insight into the operational, technical, and commercial practices of biotechs
Clinical Trials via MHRA, FDA & EU Competent Authorities
Candidate selection through successful Phase I FiH (journal paper)
Securing additional €5M investment
Cross-functional project management and end-to-end CMC for new chemical entity from late-discovery to Phase II
Small Molecules (late-stage)
Establishing global supply chains for commercial readiness (US, India, Australia, EU/UK, Taiwan, Japan)
Mundesine® approved in Japan for relapsed/ refractory Peripheral T-Cell Lymphoma (PTCL)
• CDMO transition, tech transfer, and CMC comparability with no clinical bridging
LitX® LED-activated catheter device therapy for Benign Prostatic Hyperplasia (BPH), in-licensed, drug and device development, successful End-of-Phase II meeting
Biologics (general)
Expert understanding of the organisational, technical, and commercial dynamics of top-tier CDMOs
Programme management of multiple monoclonal antibody (mAb) “gene to IND”, also late-stage process performance qualification
Due diligence activities:
antibody-drug-conjugates (ADCs), cell & gene therapies (CGT), microbiotica transplant (MT), lipid Nanoparticles (LNP)
Biologics (late-stage)
Health Authority interactions with FDA, EMA, Health Canada, TGA, MFDS
In-licensing investments for Biosimilars portfolio
• critical due diligence of MAA/BLA and supply chains
• successful variations and global market expansion
Achievements
Results that matter
Principal Consultant
Hash Patel PhD
Biopharmaceutical leader with 25+ years’ experience in drug development, CMC strategy, chemical & biologics manufacturing, and cross-functional leadership across biotech and global pharma.