AlisPharm
Consultancy supporting pharmaceutical, biotechnology and medical device organisations across development, manufacturing and post‑market phases. Services include regulatory strategy and submissions, quality systems and eQMS support, qualification & validation (IQ/OQ/PQ), physico‑chemical quality control and analytical method development, and industrialization/process optimisation. Operates across multiple countries with offices in Europe and North America.
Industries
Nr. of Employees
medium (51-250)
Products
Regulatory affairs for
Consulting and support services for medical devices under ISO13485, MDD, and MDR, including drafting technical submission files and clinical studies.
Regulatory Affairs for the Pharmaceutical Industry and Biotechnology
Packaged regulatory affairs solutions for pharmaceutical and biotechnology sectors.
Regulatory Affairs for Medical Devices manufacturers
Packaged regulatory affairs solutions specifically tailored for medical device manufacturers.
Regulatory affairs for drugs (pharmaceutical RAs)
Regulatory affairs services including marketing authorization applications, CTD and e-CTD format dossiers, and pharmacovigilance and clinic support.
Industrialization Services
Consulting and support services for the control of industrialization processes, operational efficiency, industrial transfers, commissioning, engineering, and new product industrialization in the life sciences industries.
Qualification Validation
Validation and qualification services covering computerized systems, automated systems, equipment qualification, and process validation for the pharma and biotech industry.
Regulatory affairs for
Consulting and support services for medical devices under ISO13485, MDD, and MDR, including drafting technical submission files and clinical studies.
Regulatory Affairs for the Pharmaceutical Industry and Biotechnology
Packaged regulatory affairs solutions for pharmaceutical and biotechnology sectors.
Regulatory Affairs for Medical Devices manufacturers
Packaged regulatory affairs solutions specifically tailored for medical device manufacturers.
Regulatory affairs for drugs (pharmaceutical RAs)
Regulatory affairs services including marketing authorization applications, CTD and e-CTD format dossiers, and pharmacovigilance and clinic support.
Industrialization Services
Consulting and support services for the control of industrialization processes, operational efficiency, industrial transfers, commissioning, engineering, and new product industrialization in the life sciences industries.
Qualification Validation
Validation and qualification services covering computerized systems, automated systems, equipment qualification, and process validation for the pharma and biotech industry.
Services
Strategic regulatory planning and preparation of submission files (CTD and region-specific dossiers), regulatory monitoring and post‑market vigilance support.
End-to-end qualification and validation: strategy, risk analyses, test protocols, execution and reporting for equipment, facilities, processes, packaging and computerized systems.
Analytical method development, validation, method transfer, stability study design and QC troubleshooting, including chromatography migration and automation projects.
CSV services, eQMS deployment support and computerized system validation to secure data integrity and compliance of digital systems used in regulated operations.
Support for process scale-up, packaging development, sterilisation/disinfection process validation and production line optimisation to improve robustness and speed-to-market.
Project management for regulated development and manufacturing projects, plus workshops and practitioner knowledge‑sharing for technical teams.
Strategic regulatory planning and preparation of submission files (CTD and region-specific dossiers), regulatory monitoring and post‑market vigilance support.
End-to-end qualification and validation: strategy, risk analyses, test protocols, execution and reporting for equipment, facilities, processes, packaging and computerized systems.
Analytical method development, validation, method transfer, stability study design and QC troubleshooting, including chromatography migration and automation projects.
CSV services, eQMS deployment support and computerized system validation to secure data integrity and compliance of digital systems used in regulated operations.
Support for process scale-up, packaging development, sterilisation/disinfection process validation and production line optimisation to improve robustness and speed-to-market.
Project management for regulated development and manufacturing projects, plus workshops and practitioner knowledge‑sharing for technical teams.
Expertise Areas
- Regulatory compliance and submissions
- Qualification & validation (IQ/OQ/PQ)
- Quality systems and eQMS implementation
- Analytical quality control and method development
Key Technologies
- HPLC / UPLC / UHPLC chromatography
- Chromatography automation and laboratory automation
- Stability studies in climatic chambers (ICH)
- Electronic quality management systems (eQMS) and CSV practices
News & Updates
Announcement of a partnership with a life sciences services organisation to extend testing and service capabilities.
News item describing a community of practice focused on computerized system validation and data integrity.
News item announcing a community for project management practitioners working in regulated environments.
News item describing a community focused on physico‑chemical quality control topics.
News describing a community of consultants working on medical device topics including MDR, sterilisation, packaging and biocompatibility.
News describing a community focused on qualification and validation practices across manufacturing and laboratory activities.
Announcement of a partnership with a life sciences services organisation to extend testing and service capabilities.
News item describing a community of practice focused on computerized system validation and data integrity.
News item announcing a community for project management practitioners working in regulated environments.
News item describing a community focused on physico‑chemical quality control topics.
News describing a community of consultants working on medical device topics including MDR, sterilisation, packaging and biocompatibility.
News describing a community focused on qualification and validation practices across manufacturing and laboratory activities.