our business
sectors

Management of analytical and formulation development through to transfer into production.
Definition and control of CQAs / CPPs, development of VMP, PPQ, and cleaning strategies, and production of the CMC documentation required for the transition from laboratory to industrial scale.
Securing critical stages to ensure process robustness, regulatory compliance, and industrial performance.

Management of industrialization projects including critical utilities, FAT / SAT activities, and commissioning.
Preparation and execution of DQ / IQ / OQ / PQ, deployment of PPQ stages, cleaning validation, and qualification of computerized systems (CSV – SCADA, BMS, MES, LIMS).
Ensuring GxP compliance and the operational performance of facilities.

Management of Operational Quality activities: deviations, CAPA, OOS / OOT.
Alignment of GxP QMS systems and Data Integrity, inspection readiness, and management of CMC documentation requirements (Module 3).
Control of regulatory risk and business continuity.

Management of industrial projects through structured PMOs integrating the V-cycle, ramp-up management, MRP / MPS planning, organization of ZAC flows, CAPEX / OPEX sourcing, and deployment of Lean / Six Sigma approaches.

Development and optimization of living bioprocesses
(cells, fermentation, expression).
Upstream / downstream control, identification and management of CPP / CQA.
Robustness and comparability studies, scale-up / scale-down.
Transfer of biological processes and deployment of biotech PPQ strategies.
CMC support (Module 3) to secure the transition from clinical to commercial.

Qualification and validation of critical bioproduction equipment
(bioreactors, skids, filtration, centrifugation, areas and utilities).
Validation of sensitive processes (cleaning, sterilization, aseptic).
Validation of computerized systems supporting bioprocesses
(MES, LIMS, eBR).
Securing the industrial reproducibility of living systems in GMP or advanced industrial environments.

Structuring quality systems adapted to bioprocesses,
in demanding GxP or industrial environments.
Management of complex deviations and CAPA linked to biological variability.
Oversight of Data Integrity requirements (process and analytical data).
Biotech CMC support (process, control, stability).
Preparation for and support during inspections when applicable.

Management of high-stakes biotech projects:
industrialization, capacity expansions, bioprocess transfers.
Coordination of CDMOs / industrial partners / critical suppliers.
Optimization of flows, equipment qualification,
digitalization of biotech operations (MES / LIMS).
Securing critical supplies and business continuity.

Management of activities from functional analysis through to pre-series transfer.
Definition of technical specifications, prototyping, development and execution of V&V plans, integration of DfM, and preparation of the technical elements required for regulatory submissions (CE / FDA 510(k)).

Implementation and qualification of assembly and automation lines.
Execution of device-specific IQ / OQ / PQ for MD / IVD, validation of sterilization, sealing, and dosing processes, and validation of production and inspection software.

Deployment of ISO 13485 / ISO 14971 standards, management of risk management, PMS, and vigilance.
Preparation of Technical Files, CE / FDA 510(k) submissions, supplier audits, and cleaning and performance validations.

Management of MD / IVD projects: industrial transfers, serial production lines, Quality / RA PMO.
Management of sterile flows and cleanrooms, transport qualification, sourcing of critical components, Lean initiatives, and quality digitalization.

Support for the transition from formulation to pilot to industrial scale.
Conducting stability studies, compliance and safety testing, defining process parameters and packaging constraints, and preparation of the cosmetic technical file.

Industrialization and qualification of formulation equipment and packaging lines.
Implementation of IQ / OQ / PQ, cleaning validation, and optimization of process parameters (mixing, viscosity).

Application of ISO 22716 requirements.
Control of raw materials and packaging, internal and supplier audits, preparation of the Product Information File, and verification of regulatory claim compliance.

Structuring projects from formulation through to production.
Management of range launches and format changes, sourcing of raw materials and packaging, procurement of packaging and actives, improvement of line OEE, and flow standardization.