LIFE SCIENCES SPECIALIST
At VIQI, we support Life Sciences players across all the sector's key roles.
Pharmaceuticals, medical devices, biotechnology: we work in strategic and technical areas, from R&D to market launch, to support your projects.
Our areas
of expertise
Pharmaceutical R&D
PHARMACEUTICAL PRODUCT DEVELOPMENT, FROM MOLECULE TO CLINICAL BATCHES
Formulation screening and galenic development
Analytical development
Development and testing of primary and secondary packaging
Stability studies (ICH)
Quality and process risk analyses
Container/content interaction
Pre-formulation studies and API / excipient characterisation
Launch of development and pilot batches
Preparation of CMC documentation and development dossiers
MEDICAL DEVICE R&D
MECHANICAL, ELECTROMEDICAL, IMPLANTABLE, COMBINATION AND IVD DEVICES
Design, prototyping and feasibility
Risk analysis according to ISO 14971
Biocompatibility according to ISO 10993
Usability Engineering according to IEC 62366
Complete DHF documentation
Definition and management of the verification and validation (V&V) plan
SOFTWARE R&D
Software development for medical devices and industrial systems
Definition of the system architecture
Requirements and specification management
Development, unit testing, integration
Software validation according to IEC 62304
Cybersecurity according to IEC 81001-5-1
Compatibility with electromedical equipment (IEC 60601) where applicable
ENGINEERING & INDUSTRIALISATION
Industrialisation of pharmaceutical and medical device processes
Industrial transfer and scale-up
New facilities and creation of GMP areas
Site-to-site production transfers
URS / specifications / FS / DS and risk analyses
FAT / SAT and supplier coordination
Site supervision, installation, revamping and initial qualification
Continuous improvement
Qualification, validation & CSV
COMPLIANCE OF EQUIPMENT, PROCESSES AND SYSTEMS
Qualification / validation strategy and risk analyses
Qualification of equipment, utilities and infrastructure (FAT / SAT / IQ / OQ / PQ)
Validation of manufacturing, cleaning and sterilisation processes
Qualification of laboratory equipment and analytical systems
Validation of computerised systems: ERP, MES, LIMS, EDMS, SCADA…
GAMP 5 / 21 CFR Part 11 / Annex 11 compliance
Maintaining the qualified and validated state throughout the life cycle
AUTOMATION & INDUSTRIAL IT
DIGITALISATION, CONTROL AND PERFORMANCE OF INDUSTRIAL SYSTEMS
Architecture of automated systems and industrial infrastructure
Programming and configuration of PLCs, HMIs and SCADA systems
Development and optimisation of sequences, recipes, interlocks and alarms
OT / IT systems integration and equipment interfaces
Supervision, data historisation and industrial data management
Deployment and evolution of MES systems and production tools
Diagnosis, reliability improvement and enhancement of automated systems
QUALITY CONTROL LABORATORY
Quality control laboratory
Method development and validation
Management of OOS, OOT and analytical investigations
Strict application of ALCOA principles
Support for method transfers
QUALITY ASSURANCE & DATA INTEGRITY
QUALITY SYSTEMS, COMPLIANCE AND DATA CONTROL
Management of deviations, NCs, CAPAs and Change Control
Quality investigations and resolution of complex issues
Preparation and support for audits and inspections
Implementation, optimisation and digitalisation of QMS
Data governance and Data Integrity compliance (ALCOA+)
Support for operations in GMP environments
Deployment of Quality IT systems: eQMS, EDMS, LIMS, ERP…
REGULATORY AFFAIRS
Regulatory compliance across the entire product life cycle
Medical devices: CE marking and 510(k) dossiers
Pharma: creation and updating of marketing authorisation dossiers
Regulatory submissions: international registrations (US, EU, ROW)
MDR transition and maintenance of compliance
PMS: pharmacovigilance and medical device vigilance
Responses to health authorities
Clinical evaluation (CEP/CER)
The STRENGTHS of
our approach
Dedicated expertise for each key area
Fast, agile response capability
High standards of compliance
An approach guided by a sense of service
A FEW CLIENTS FROM THE PHARMACEUTICAL industry
A FEW CLIENTS FROM THE MEDICAL DEVICE INDUSTRY
