Project Portfolio
A selection of completed mandates – condensed, anonymised, with a clear focus on outcomes.
In the overview below we deliberately omit client names and granular detail – out of respect for confidentiality and the trust on which our engagements are built.
Inspection Aftermath
Client: global, mid-sized · Duration: 2.5 + 2 months · Area: Wholesale / QA
Scope: Eliminate an APQR backlog of 200 reports within 10 weeks and build sustainable systems for ongoing compliance.
Result: Backlog fully eliminated, re-inspection readiness restored; supporting systems prevent recurrence.
Vaccine PPQ
Client: global, large · Duration: 2.5 months · Area: Pharma, QM
Scope: Establish an optimised PPQ schedule and FMEA to ensure timeline adherence on a delayed project.
Result: Optimised PPQ schedule delivered, FMEA finalised, schedule stabilised.
QUASY™
Client: internal · Duration: 10 months · Area: QMS
Scope: Build a QMS engine that makes an “instant QMS” available for SMEs.
Result: Standalone tool QUASY™ released; ongoing extensions into new areas (currently MedTech).
Procurement Compliance
Client: global, mid-large · Duration: 5 months · Area: Biotech, Procurement / QA
Scope: Map procurement risks, develop and implement mitigation – for a fast and compliance-ready supply base.
Result: Established interface function across Supply Chain, QA, Purchasing, and QC; built and rolled out a training plan; co-optimised the material qualification process.
Interim Manager
Client: global, mid-large · Duration: 4 months · Area: Biotech, Procurement / QA
Scope: Interim coverage of the role until a suitable permanent hire was in place.
Result: Role profile built, candidate interviews conducted; ongoing compliance in deviation and change-control management secured; open supplier qualifications closed out.
Sourcing Risk Mitigation
Client: global, mid-large · Duration: 12 months · Area: Biotech, Procurement / QA
Scope: Increase the overall robustness of sourcing – from material qualification through to audit readiness.
Result: Material qualifications completed on time, supplier qualifications cleaned up, “true” supply chains for critical materials mapped to source, second-source concept implemented, balanced scorecards introduced as steering instrument, SPOC for internal audits towards procurement, inspection readiness for new authorities established.
Quality Technical Agreement
Client: national, mid · Duration: 8 months · Area: Pharma
Scope: Maternity-leave coverage in QTA / QAA management.
Result: Backlog progressively reduced during the leave period.
Backlog Elimination
Client: national, mid · Duration: 12 months · Area: Pharma
Scope: Full elimination of an existing QTA / QAA backlog.
Result: Backlog fully eliminated.
Create and Implement a QMS
Client: national, small · Duration: 8 months · Area: Biotech, QA
Scope: Build a workable QMS that enables commercialisation.
Result: Full QMS established, transferred into a new eQMS, three new staff onboarded to secure ongoing compliance.
N2K Expert / Eliminating Deviation Backlog
Client: global, large · Duration: 4 months · Area: Pharma, QA
Scope: Eliminate an existing deviation backlog.
Result: Backlog fully cleared and delays in the relevant deviations resolved.
Creating an API Wholesaler
Client: national, small · Duration: 8 months (part-time) · Area: API Wholesale
Scope: Compliance-side support for the build-up of an API wholesale operation.
Result: Interim Managing Director per Trade Law, turn-key business solution, QMS, commercial filings, SMF and SOPs created; agency inspections defended, supplier audits performed – concluded with a granted GDP licence.
Rescue a Failed Submission
Client: national, small · Duration: 2 months · Area: Wholesale
Scope: Fix a rejected filing and address the underlying QMS gaps.
Result: QMS gaps and system checks addressed, procedures updated, staff retrained, storage mapping reports rebuilt; inspection prep and response letter handled – led to the desired GDP certificate.
Process Validation
Client: global, large · Duration: 18 months · Area: Pharma / PV
Scope: Support process validation for three new drugs.
Result: Lifetime validation, hold-time validation, PPQ, continued validation reporting, regulatory filing prep, agency response support.
Agreement Backlog Fixture
Client: national, mid · Duration: 6 (+6) months · Area: Pharma
Scope: Reduce an existing QTA / QAA backlog.
Result: Backlog substantially reduced; extension halted due to recession-driven budget pressure.
Wholesale RP
Client: national, mid · Duration: ongoing · Area: Wholesale
Scope: Hold the Responsible Person function, maintain QMS, ensure GDP compliance.
Result: Engagement ongoing.
Project Management Veterinary
Client: global, large · Duration: 10 months · Area: Veterinary
Scope: Interim project management for production equipment.
Result: More than 20 small equipment projects delivered from URS to completion (depending on the takeover stage and tenure end).
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