Consulting Services
Whether it is for temporary resource increase on a project or for a specifically required competency, we can provide customized solutions throughout the entire product life cycle.
Our main added values are:
- to have a deep knowledge and understanding of Life Sciences strategic, regulatory and operational challenges, as well as industrial processes, across the entire value chain (R&D, Clinical Trials, Engineering, Production, IS/IT, etc.);
- to provide optimal bundled solutions coupled with implementation strategies, deployment plans and risk mitigation plans;
- to integrate the Regulatory and Quality requirements impacting the Business.
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Innovation & Business Strategy
Our strength is in our specialization. Because we have built up a deep Life Sciences market and process expertise, we are best positioned to understand our clients’ business challenges, and support them when it comes to Innovation & Business Transformation.
- Identify internal drivers of innovation emerging from our client’s science and technologies
- Undertake market studies and competitive analysis and evaluate portfolio potentials
- Conceptualize new business opportunities and models
- Formalize value propositions based on a differentiating positioning and offering
- Prepare the business case, deploy and carry out the launch strategy and the transformation plan based on an assessment of operational impact
- Bring Engineering and Process solutions to Technology Management and New Product Development (NPD) challenges, including Technology Transfer from R&D to Manufacturing
Regulatory Compliance
We support GxP-regulated companies in the design, implementation, management, evolution and audit of their Regulatory Compliance activities.
- Market entry strategy of Medical Devices (93/42/EC, AIMD, IVD, etc.)
- Submission of Medical Devices (PMA, 510(k), CE marking, ENVISA, JPAL, etc.)
- Market entry strategy of Combination Products (21 CFR 3.2(e))
- Submission of Combination Products (BLA, NDA, PMA)
- Market entry strategy of Pharmaceuticals (FDA, centralized EU, other markets)
- Submission of Pharmaceuticals (INDA, NDA, ANDA)
- Pharmacovigilance, Drug Safety and Post-Market Surveillance
- Dispute Resolution
- FDA-483, Warning Letter, Untitled Letter Response Strategy
- Recall
- Audit Non-conformance Response Strategy
- Acquisition Due Diligence
- Inspectional Readiness Programs for Inspections and Notified Body Audits
- Internal Audits
Quality Management
We support GxP-regulated companies in the design, implementation, management, evolution and audit of their Quality Management activities.
- Quality Management System
- Quality Management System Development / Optimization and Gap Analysis
- ISO 13485, 21CFR Part 820, ISO 9001, ICH Q7, Q8, Q9 & Q10, 21CFR Part 11, ISO 17025, cGMP
- Validation & Qualification
- Risk Management and Design Control
- Design Control, DHF, DMR according to ISO13485/FDA QSR
- Risk Management (ISO 14971, ICH Q8 and ICH Q9)
- Risk Analysis / Risk Management methodology (D-FMEA, P-FMEA)
- Human Factors/Usability
- Human Factors engineering and studies (formative/summative) monitoring
- ISO 62366
- Quality Management System Auditing
- Suppliers Auditing
- QMS Auditing (Internal Audits, Process Audits)
- Third Party Audit Preparation (Mock Audits)
Information Systems & Digital Transformation
We support R&D, Operations and IS/IT teams to define, build, maintain and support software solutions and infrastructures in the Life Sciences Industry.
- Research & Development (R&D) / Operations
- High level strategic planning of Business Solutions (Master Plan)
- Requirement definition, Support to Solutions supplier selection
- Project Management
- Computerized System Validation (CSV) according to GAMP5 (Validation Master Plan, Validation Plan, CAPA Risk Analysis, DQ, IQ, OQ, PQ etc…)
- Information Systems (IS) / Information Technology (IT)
- High level strategic planning of Life Sciences IS/IT solutions (Master Plan)
- Computer System Validation of Off the Shelf or highly customized Laboratory and Manufacturing Systems as well as ERPs, from Validation lead to scripts/test execution and document writing
- Project Management: methodology (CMMI, PMP, PM process definition) and operational project management
- Specialized implementation and development services (ex: Bio informatics, Chemo informatics, LIMS, ELN, EDMS, CTMS, CDMS etc…)

Industrial Process
We can undertake all phases of any Engineering activity: project management, design, construction, commissioning and validation until the hand-over of a complete plant, facility or production line.
- Facilities and Processes
- Technical Studies, Construction Management, Basic Engineering, Detailed Engineering, Workflow optimization, Resource Planning and Coordination, Cost tracking, Project management, Plant management, Validation
- Equipment (for Manufacturing and R&D Laboratories)
- Requirement Specification (URS), Functional Design Specification (FDS), Detailed Design Specification (DDS) Procurement (Tender), Workflow optimization, FAT, Commissioning, SAT, Calibration, Metrology, Qualification, Go live, Maintenance, Decommissioning and retirement
- Utilities
- Requirement Specification (URS), Functional Design Specification (FDS), Detailed Design Specification (DDS), Commissioning and Qualification of Pharmaceutical Water and Steam Systems including HVAC
- Automated systems
- DCS, SCADA, MES, PLC, etc.
- User Requirement Specification (URS), Functional Design Specification (FDS), Detailed Design Specification (DDS), Procurement (Tender), Development, FAT, Commissioning, SAT, Qualification, Validation, Go live, Project Management
- Project Engineering
- Project Infrastructure, Project Organization, Project Management, Value Analysis, Planning, Programming and Monitoring, Design Reviews, Handover
- Methodologies and Tools
- Project Management Institute (PMI), IPMA, CMMi, GAMP5
- 6 Sigma, Kaisen, 5S, SMED, 5M, Ishikawa, TPM, Lean Sigma, VSM, Kanban