Biopharma industry. Innovative consulting services for managing patient risk through People and Expertise

Transcription

1 Biopharma industry Innovative consulting services for managing patient risk through People and Expertise Drug Lifecycle Performance for Patient Safety 1 AKT_I046A_0591_15_Pres_AKTEHOM_EN.pptx

2 AKTEHOM Independent consulting company dedicated to Life Science Industries Expert in Product / Process understanding Anticipation of regulatory requirements Committee involvement & publications Official on-site & off-site Training 50 people 4 agencies : Paris, Lyon, Colmar, Brussels Turnover : 6 M Interventions Worldwide Supporting our clients in the understanding and control of product/process link, to achieve patient safety, drug quality and performance 2

3 Consultancy Market Three main categories of needs that require a specific approach: Solution Provider Strategic Consultancy C Companies stakes Complex solutions Specific issues High level of expertise Design & implementation Commitment to results Lead and project management Management & risk analysis of project Adaptability & Reactivity Innovation & pragmatism Staffing Service Sub-contractor Availability of resources Needs/ commitment Long-term missions 3 Consultancy Market Pyramide Oresys

4 AKTEHOM s position Solution Provider Strategic Consultancy C AKTEHOM CONSULTING Product/Process Management Strategy Organization and Mindset Evolution Expertise AKTEHOM SOLUTION PROVIDER Packaged solution delivery Deliverable-based AKTEHOM autonomy/partnership Dynamic resource allocation Staffing Service Sub-contractor 4

5 AKTEHOM Continuous Innovation Operational tools implementing Regulatory Requirements to anticipate future industrial needs AKTEHOM s Product development chart Mindset Evolution Control Strategy Process Characterization Design Space QbD / Lean KM Data Management AKTEHOM s birth Product Characterization Single-Use Comparability Process Validation Combined Products AQbD Description process Risk Management Change Management ICH Q7A ICH Q8 ICH Q8R2 ICH Q3D ICH Q12 ICH M4Q(R1) ICH Q5E ICH Q9 ICH Q8R1 ICH Q11 MD EU Regulation Quality by Design ICH Q10 Process Validation EU Data Integrity Critical Path Process Validation FDA PAT Process Analytical Technology Pharmaceutical cgmps for the 21st Century A Risk Based Approach 5

6 How does AKTEHOM act? Strategy Definition of a strategy to answer the client's concern / issue Proposal of AKTEHOM s methodology Implementation plan Implementation Project management Resource allocation Deliverables development Customers decisions support Internalization Methodology transfer People training Transposition of documents Mission lead Skills engagement Methodology implementation know-how Front office / back office optimized mix Dynamic workload, day-to-day management Operational Activities Staffing Assignment Innovation Single interface & AKTEHOM team autonomy Applying right skills at the right time Optimal efficient client input Optimized cost & Project Risk Management Skills 6 Commitment on results Guaranteed results

7 AKTEHOM s mission scope Product / Process Implementation of Quality by Design Characterization studies (DoE, Design Space) Process optimization Drafting of technical data (CMC) for regulatory submission Commissioning & Qualification Equipment / Sites / Utilities Laboratory equipment Information Systems Validation Process Validation Product / Process Risk Analysis Control Strategy Process Validation Process Transfer Monitoring of products / processes Analytics Analytical QbD Technical Transfer and Validation of analysis Compliance Regulatory surveillance & Interpretation of regulations Inspections / compliance assessment Support for injunction procedures Product & Process Understanding & Control Biological & Biotechnologies Small Molecules Medical Devices People & Organization Cultural change Technical and personal development coaching, mindset evolution Training Contamination Control Cross Contamination Microbiological and particles Contamination Cleaning Process, Decontamination & Sterilization Extractables and leachables (Single Use Systems) Quality Systems Risk Management Process Control (deviation, Change, CAPA ) Management of third parties Data management / Data integrity Quality Systems and Product Lifecycle requirements 7

8 Your AKTEHOM team is closer than you think AKTEHOM Brussels South Center Titanium Place Marcel Broodthaers, Brussels Belgium AKTEHOM Paris 89 avenue du Maréchal Joffre Nanterre - France AKTEHOM Colmar 3 place de la gare Colmar - France AKTEHOM Lyon Berges du Rhône 64 avenue Leclerc Lyon - France