Syntelis Consulting

Syntelis Consulting delivers independent strategic advisory and operational consultancy to the biopharmaceutical sector. We specialise in advanced therapy medicinal products (ATMPs), cell and gene therapies, and immuno-oncology. Our advisory bridges early clinical development with vein-to-vein operations and global quality governance; translating complex operational workflows into robust regulatory submissions that accelerate commercial approval.

Capabilities

Vein-to-Vein Operations & Cell Journey Architecture

Turning complex biological therapies into scalable, error-proof clinical and commercial delivery pathways.

End-to-End Operating Model Design: Building the clinical supply pathway connecting apheresis collection, CDMO manufacturing slots, cryogenic logistics, and hospital infusion.
Chain of Identity & Custody (CoI/CoC): Architecting robust, standards-compliant tracking systems (including ICCBBA ST-028 alignment) that eliminate sample mix-up risks.
Workflow Error-Proofing & Tooling: Developing practical validation tools, Release for Infusion (RFI) controls, and automated certificate generators to de-risk manual operational handoffs.
Bedside Delivery & Pharmacy Handling: Establishing receipt verification protocols, dry-shipper handling, pharmacy thaw-and-infusion workflows, and ward coordination for clinical sites.

Apheresis Quality Systems & Global Site Governance

Establishing the compliance frameworks, agreements, and qualification gates required to scale multi-centre and international trials.

Global Quality Agreement Architecture: Authoring and negotiating regional and international Quality Technical Agreements (QTAs) across UK, EU, US, and emerging markets.
Site Qualification & Onboarding: Setting up auditable qualification, reassessment, and activation frameworks for collection centres, cell labs, and hospital pharmacies.
HTA, SoHo, GCP & GMP Inspection Readiness: Preparation for EU SoHO Regulation compliance, HTA licensing, mock audits, and cross-border regulatory alignment (HTA, MHRA, EMA, FDA).
Special Access & IST Enablement: Designing governance pathways for Investigator-Sponsored Trials (e.g., German ISTs) and Named Patient / Compassionate Use programs.

Regulatory Filings & Commercial Readiness

Bridging clinical operational reality with regulatory submission content and post-approval commercial readiness.

BLA / MAA Submission Support: Technical lead for file preparation, drafting IMPD/CTD technical narratives, and authoring responses to agency questions (EMA RtQ/RtI, FDA).
Product Information & Label Governance: Designing master product label text processes, country-specific labeling, CTA submission labels, USPI, and SmPC implementation.
Supply Chain Regulatory Strategy: Formulating testing-site strategies, transport validation evidence, and release criteria required for marketing authorisation applications.
Investor & M&A Technical Diligence: Independent operational audits for venture capital and pharma BD evaluating platform scalability, regulatory maturity.

Leadership

Dr William Shingler, MBA (Oxon)
Founder & Principal

Syntelis is led by William Shingler, Founder & Principal, bringing over 20 years of biopharmaceutical development and leadership experience. He combines a deep scientific foundation (BSc Biochemistry & Genetics; PhD in Biomedical Sciences focussed on Oncology and Immunology) with robust commercial acumen, holding an Executive MBA with distinction from the Oxford Saïd Business School.

His background spans senior leadership across pioneering organisations including Autolus Therapeutics, Immunocore, Novartis, and Oxford BioMedica (OXB). Most recently serving as Senior Director of Patient & Cell Management, he led the global operating model and apheresis quality architecture for commercial and clinical-stage CAR-T programmes, contributing directly to BLA/MAA regulatory submissions, HTA/SoHO governance, and international cell therapy traceability standards (ICCBBA ST-028).

Our full website is currently under development.

Get in Touch