Pharmaceutical Industry
QMS compliance, data review, IS validation, preparation of registration dossiers, toxicological evaluation, data analysis — Qualilab, an expert in pharmaceutical standards, is able to work within R&D laboratories, on production and distribution sites in the pharmaceutical industry, as well as with its suppliers and subcontractors.
Our Support Services for the Pharmaceutical Industry
Qualilab assists its clients in the pharmaceutical industry with the transformations needed to meet new challenges — from evaluating key issues to implementing the full range of operational performance levers.
Our services related to the Pharmaceutical Quality System
As part of our support, we offer you:
- Quality Assurance (validation, risk analysis, deviations, non-conformity management, corrective and preventive actions, audits, etc.)
- Implementation and compliance of Quality Management System (GxP, BPx, etc.)
- Development of specific Quality Processes/Procedures aligned with regulatory requirements
- Internal and subcontractor audits
- Qualification and validation of computerized systems
- Data review and report auditing
- Statistical analysis of results
- Drafting protocols and reports for method validation and analytical transfer
- Inspection readiness support (ANSM, FDA, etc.)
- Assistance with registration strategy
- Coordination of studies
- Drafting of MAA dossiers (Module 3)
- Preparation of product information documents (SmPC, package leaflet, and labelling)
- Non-clinical toxicological assessments (impurities, excipients, residues)
- Publishing and submission of dossiers
Our areas of expertise
Our team operates across key domains of the pharmaceutical sector:
- Research & Development (R&D)
- Logistics and Supply Chain
- Validation
- Quality Control
- IT and Data Systems
- Clinical
- Regulatory Affairs
- Pharmacovigilance
OUR TRAINING COURSES
As a certified training organization, Qualilab offers modules tailored to the pharmaceutical industry:
- 1Q1: Conducting Internal Audits
- 2P2: GMP for Investigational Medicinal Products in accordance with Annexes 13 and 16
- …
Why choose Qualilab
With extensive expertise in international regulations and hands-on experience in the pharmaceutical industry, we have developed a comprehensive range of services tailored to the evolving demands of the sector.
Our recognized expertise enables us to operate across the entire pharmaceutical value chain — from R&D laboratories to active ingredient manufacturers and pharmaceutical companies.
A team at your service
Our team is here to guide and support you in managing your project. Our consultants are available to provide insights into the scope and content of our services, if needed.
