Qualipharma
Qualipharma Group is dedicated to providing innovative solutions and expert services in the pharmaceutical industry, including regulatory affairs, quality compliance, validation, and digital solutions. The company aims to enhance efficiency, ensure compliance, and support growth for its clients through a range of specialized services and digital tools.
Industries
Nr. of Employees
medium (51-250)
Qualipharma
Products
Digital regulatory dossier management platform
A platform for centralizing regulatory documentation, providing version control, traceability, automated checklists and workflow automation to support preparation and submission of regulatory dossiers.
Digital regulatory dossier management platform
A platform for centralizing regulatory documentation, providing version control, traceability, automated checklists and workflow automation to support preparation and submission of regulatory dossiers.
Services
Gap analysis, compilation of historical authorizations, preparation of variation strategies and creation of consolidated eCTD submissions (sequence 0000) to update marketing authorizations.
Commissioning and qualification of facilities and equipment and execution of validation protocols to demonstrate conformance with approved processes.
Validation and assurance services for regulated IT systems, including data integrity assessments and validation lifecycle activities.
Design and implementation of quality systems, GMP/GDP compliance support and inspection readiness.
Regulatory pathway design, agency liaison and advice on national and regional submission routes, including botanical and cannabis-derived products.
Operational improvement projects using lean manufacturing and continuous improvement to increase productivity and efficiency across manufacturing and logistics.
Gap analysis, compilation of historical authorizations, preparation of variation strategies and creation of consolidated eCTD submissions (sequence 0000) to update marketing authorizations.
Commissioning and qualification of facilities and equipment and execution of validation protocols to demonstrate conformance with approved processes.
Validation and assurance services for regulated IT systems, including data integrity assessments and validation lifecycle activities.
Design and implementation of quality systems, GMP/GDP compliance support and inspection readiness.
Regulatory pathway design, agency liaison and advice on national and regional submission routes, including botanical and cannabis-derived products.
Operational improvement projects using lean manufacturing and continuous improvement to increase productivity and efficiency across manufacturing and logistics.
Expertise Areas
- Regulatory affairs and submission strategy
- Regulatory dossier management and eCTD lifecycle
- Pharmaceutical quality systems and GxP compliance
- Computerized system validation and data integrity
Key Technologies
- eCTD / electronic regulatory submissions
- Document management systems with version control
- Computerized system validation methodologies
- Automated workflow and checklist engines
News & Updates
An analysis of the main challenges in preparing and submitting regulatory dossiers in the pharmaceutical industry.
Discussion on the risks associated with pharmaceutical registrations and procedures.
An overview of the regulatory frameworks for medicinal cannabis across European countries, including legal status, regulations, and recent changes.
An analysis of the main challenges in preparing and submitting regulatory dossiers in the pharmaceutical industry.
Discussion on the risks associated with pharmaceutical registrations and procedures.
An overview of the regulatory frameworks for medicinal cannabis across European countries, including legal status, regulations, and recent changes.