Service lines
What we do
Most engagements draw on two or three disciplines at once, run by one named lead so the interfaces are somebody's job.
01Regulatory Affairs+
US submissions, agency strategy and negotiation, expedited pathways, global filings, standards interpretation, labelling and advertising review.
Clinical hold responses, Complete Response Letter remediation, recalls, import alerts, notified body nonconformity closure and regulatory intelligence.
02CMC, Manufacturing & Validation+
Phase-appropriate CMC plans, Module 3 authoring, scale-up, analytical development, stability and packaging validation.
CDMO and laboratory qualification, supplier control, equipment qualification, process validation and software assurance.
03Clinical Development & Operations+
Clinical strategy, trial design, protocols, statistical plans, CRO selection and site delivery.
Data governance, evidence strategy, investigator materials, literature review and clinical evaluation.
04Pharmacovigilance & Drug Safety+
Safety Management Plans, controlled case repositories, safety agreements, training and migration planning.
Case management, expedited reporting, aggregate reports, reconciliation, signal review and monthly metrics.
05Quality Systems & Compliance+
Phase-appropriate QMS, document control, CAPA, risk management, electronic QMS and data integrity.
Practice inspections, GxP audits, MDSAP readiness, inspection hosting and response drafting.
06Strategy, Diligence & Program Management+
Market, scientific and regulatory intelligence; portfolio selection, diligence and reimbursement strategy.
Integrated plans, budgets, board reporting, stakeholder presentation, training and programme recovery.
Sectors
Where we work
Weighted toward drugs and biologics, with a long device and diagnostics history behind it.
Four ways to bring us in
Fractional leadership, defined work, embedded teams or an independent review.