Consult

IR35 Advisory
Our Interim Practice advised a global biopharmaceutical business through changes in workforce regulation (IR35) by implementing a bespoke assessment process, hosting training to upskill existing consultants, and fulfilling mandates for new interim managers.

Pre-Audit Inspection
Assisted a European speciality pharmaceutical company seeking FDA approval for a new sterile product by building an FDA steering team, including mandates for an FDA Programme Lead, Interim Quality Director, Technology Transfer Consultant, as well a range of requirements across QA, QC, technical operations, and engineering.

Global Expertise
Advised and delivered a confidential UK government-backed COVID-19 project for a pharmaceutical business acquiring a new facility. This involved engaging global industry expertise and delivering creative solutions during unprecedented working conditions.

Remediation
Delivered a project of consultants to build out a remediation team for MHRA and FDA compliance for the client’s UK GMP manufacturing facility. Interim mandates included Project Lead, QMS consultant, Engineering Lead, and Validation Consultant.

