Project Portfolio

Please find a brief overview of our project portfolio attached. Please understand that we will not go into details to protect our clients.
Disclaimer: DALL-E is not a friend of correct spelling, so pictures may be flawed.

Inspection Aftermath

Client Org Size: Global, mid-sized
Duration: 2,5mon+2mon
Area Wholesale/ QA
Scope: Eliminate a 200 APQR backlog within 10 weeks, Create sustainable systems to ensure ongoing compliance
Result: Eliminated entire backlog to ensure reinspection readiness. Mitigating measures and systems were implemented to avoid reoccurance.

Vaccine PPQ

Client Org Size: Global, large
Duration: 2.5mon
Area: Pharma, QM
Scope Create an optimized PPQ schedule, create FMEA to ensure timeline adherence of delayed project
Result: Create an optimized PPQ schedule, created FMEA

QUASY™

Client Org Size: Internal
Duration: 10mon
Area: QMS
Scope: Creating a QMS engine to allow "instant QMS" Result: Completed a standalone tool (QUASY™); ongoing improvements adding new areas (up next MedTech)

Procurement Compliance

Client Org Size: Global, mid-large
Duration: 5mon
Area: Biotech, Procurement/QA
Scope: Map risks, establish and implement mitigation strategies for fast and compliant sourcing
Result: Established a interface function for supply chain, QA, Purchasing and QC; created a new training plan and trained the department, co-created a optimized material qualification process

Interim Manager

Client Org Size: Global, mid-large
Duration: 4mon
Area: Biotech, Procurement/QA
Scope: Interim Manager until a suitable employee was found
Result: Creating the role profile, interviewing candidates, ensuring ongoing compliance (deviation and change control management), eliminating supplier qualification issues

Sourcing Risk Mitigation

Client Org Size: Global, mid-large
Duration: 12mon
Area: Biotech, Procurement/QA
Scope: Improving overall robustness
Result: Ensured material qualification was completed on time, supplier qualification went smooth, mapped "true" supply chains for all critical materials to the end, implemented a second source concept, introduced balanced score cards as management tool for supplier management, SPOC for internal audits towards purchasing, ensured inspection readiness for new regulatory bodies and tender preparedness

Quality Technical Agreement

Client Org Size: National, mid
Duration: 8mon
Area: Pharma
Scope: Maternity Substitution
Result: Reduce QTA/QAA backlog during maternity leave

Backlog Elimination

Client Org Size: National, mid
Duration: 12mon
Area: Pharma
Scope: Eliminate QTA/QAA backlog
Result: QTA/QAA backlog eliminated

Create and implement a QMS

Client Org Size: National, small
Duration: 8mon
Area: Biotech, QA
Scope: Create a suitable QMS in order to allow commercialisation
Result: Created entire QMS, transferred into a new eQMS, trained new stuff (3FTEs) to ensure ongoing compliance

N2K Expert/ Eliminating Deviation Backlog

Client Org Size: Global, large
Duration: 4mon
Area: Pharma, QA Scope Eliminate Deviation backlog Result: Eliminated entire backlog and delays for outlined deviations

Creating a API Wholeseller

Client Org Size: National, small
Duration: 8mon (Part time)
Area: API Wholesale
Scope: Support Wholesale start-up compliance-wise
Result: Interim Managing Director per TradeLaw, Created a turn-key business solution, created QMS, secured commercial filings, Created SMF + business SOPs, defended inspections from agencies, and performed provider audits. Concluded by successful GDP licence.

Rescue a failed submission

Client Org Size: National, small
Duration: 2mon
Area: Wholesale
Scope: Fix failed filing
Result: audited QMS gaps, and system checks, updated procedures to eliminate identified issues, trained stuff on new procedures, created/fixed storage mapping reports.

Process Validation

Client Org Size: Global large
Duration: 18mon
Area: Pharma/PV
Scope: Support Process validation for 3 new drugs
Result Lifetime validation, hold-time validation, Process Performance Qualification, continued validation reporting, regulatory filing preparation, agency response support,

Agreement Backlog Fixture

Client Org Size: National, mid
Duration: 12mon
Area: Pharma
Scope: Eliminate QTA/QAA backlog
Result: ongoing*

Wholesale RP

Client Org Size: National, mid
Duration: TBD
Area: Wholesale
Scope: Responsible Person, QMS, GDP Compliance
Result: ongoing*

Project Managment

Client Org Size: Global, large
Duration: 10mon
Area: Veterinary
Scope: Interim PM for Production Equipment
Result: Handled and completed +20 small equipment projects from URS to completion (depending on the stages of the take over, and tenure end)