Case Studies
A selection of the work we deliver across the pharmaceutical product lifecycle — from regulatory submissions to reimbursement and quality.
Selected Work
Proven results for our clients
Each engagement is tailored to the client and the product. Below are representative examples of the challenges we solve.
Market Access
Biosimilar Reimbursement Submission
ChallengeA biosimilar sponsor needed to secure reimbursement in Greece against established originator competitors.
What We DidBuilt the full HTA assessment dossier for the reimbursement authority, including a cost-minimization analysis and budget-impact model demonstrating substantial payer savings.
ResultA complete, defensible submission that positioned the product for a favourable reimbursement decision.
Regulatory Affairs
eCTD Submission to EOF
ChallengeA client needed a compliant Marketing Authorization dossier submitted to the Greek National Organisation for Medicines under tight timelines.
What We DidCompiled and quality-checked the complete eCTD dossier and managed the EOF liaison end-to-end.
ResultA clean submission accepted without major deficiencies.
Quality & Audit
GMP Inspection Readiness
ChallengeA manufacturer faced a high-stakes GMP inspection with limited internal preparation.
What We DidRan a full audit-readiness programme — gap assessment, remediation and a mock inspection.
ResultThe client passed the inspection with zero critical findings.
Pharmacovigilance
Pharmacovigilance System Set-Up
ChallengeA company entering the Greek market needed a compliant PV system from scratch.
What We DidEstablished the PV system, PSMF and reporting workflows and provided ongoing safety-officer support.
ResultA seamless transition to a fully compliant, audit-ready PV function.
Client identities are anonymised or used with permission. Details available on request.
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