Strategiqual
Strategiqual is a consulting and services firm specializing in the pharmaceutical and medical device sectors. They offer innovative and personalized solutions in regulatory affairs, quality management, market access, and training. As part of ProductLife Group since 2023, they leverage a global network to support the lifecycle management of medical products and facilitate market entry and digital transformation. Their team of 60 expert consultants provides high-end services to clients across various regions, with offices in Paris, Nantes, Lille, and Toulouse. They are certified in ISO 9001:2015, ISO 14001:2015, ISO 13485:2016, and QUALIOPI, and have served over 500 clients with a success rate of 40% annual revenue growth and 100 successful inspections and audits.
Industries
Nr. of Employees
small (1-50)
Strategiqual
Services
Consulting to design, implement or upgrade QMS and GxP processes, including SOPs, risk management and ISO alignment.
Regulatory planning and preparation of market authorization dossiers and technical files for Europe, US and international markets.
Preparation for regulatory inspections, coaching of personnel, drafting of inspection plans, and operational response to enforcement actions.
Assessment of technology value, preparation of medico-technical and economic reimbursement dossiers and stakeholder engagement with payers and HTA bodies.
Support for preclinical and clinical strategy, protocol development and operational planning for clinical programs.
Validation of computerized systems and regulatory support for digital health solutions and software medical devices.
Consulting to design, implement or upgrade QMS and GxP processes, including SOPs, risk management and ISO alignment.
Regulatory planning and preparation of market authorization dossiers and technical files for Europe, US and international markets.
Preparation for regulatory inspections, coaching of personnel, drafting of inspection plans, and operational response to enforcement actions.
Assessment of technology value, preparation of medico-technical and economic reimbursement dossiers and stakeholder engagement with payers and HTA bodies.
Support for preclinical and clinical strategy, protocol development and operational planning for clinical programs.
Validation of computerized systems and regulatory support for digital health solutions and software medical devices.
Expertise Areas
- Regulatory compliance for pharmaceuticals and medical devices
- Quality management systems (GxP, ISO standards)
- Market access and reimbursement strategy
- Clinical development and preclinical strategy
Key Technologies
- Computerized system validation
- Software as a medical device (SaMD) compliance
- Quality management systems (ISO 13485, ISO 9001, ISO 14001)
- Regulatory submission pathways (technical files, PMA, 510(k), CE marking)
News & Updates
ISO 9001:2015 Certification
Management of quality according to ISO 9001:2015 standards.
ISO 14001:2015 Certification
Environmental management system certification.
ISO 13485:2016 Certification
Quality management system for medical devices.
QUALIOPI Certification
Certification for training actions.
DPC Certification
Continuing Professional Development certification.
ISO 9001:2015 Certification
Management of quality according to ISO 9001:2015 standards.
ISO 14001:2015 Certification
Environmental management system certification.
ISO 13485:2016 Certification
Quality management system for medical devices.
QUALIOPI Certification
Certification for training actions.
DPC Certification
Continuing Professional Development certification.