Biotechnologies and Medical Devices
Qualilab offers its support to companies in the biotechnology and medical device sectors for control or validation measures, product or process monitoring plans, the preparation of regulatory dossiers, clinical and toxicological evaluations, the implementation of QMS, as well as the performance of quality audits of partners involved in development projects.
Our Support Services for Biotechnology Companies
As part of our support, we offer you the following services:
- Support for project deployment through selection or qualification audits of partners involved in product development
- Advice for your scale-up projects: Preliminary Project Summary (PPS) reviews, process risk analyses
- Assistance in the day-to-day management of Quality Assurance (QA Logistics and Supply, QA Production, QA Information Systems, QA Pharmacovigilance)
- Coaching of Quality Managers
- Support following regulatory inspections for testing facilities (GLP, GCLP), manufacturers (GMP/GDP) and operators (GVP)
- Support for implementing or managing information systems
- Information system validation
- Analytical support, including method validation, analytical validation, analytical transfer, etc.
- Statistical analysis
- Staff training in GxP standards, investigational drugs, and cold chain logistics
- Support for regulatory dossiers and toxicology
Preparation of technical files in accordance with Regulations (EU) 2017/745 and 2017/746, MDR (Medical Devices (MDs)/In Vitro Diagnostic Medical Devices (IVDs)/Combination Products)
Biological Risk Assessment (BRA) and Toxicological Risk Assessment (TRA)
Clinical evaluations (CEP/CER)
Post-market surveillance (PSUR, PMCF, PMS)
Risk management documents, EGSP
Usability evaluation
Regulatory monitoring
Support for interactions with notified bodies
Regulatory roadmaps
oUR TRAINING COURSEs
As a certified training organization, Qualilab offers modules tailored to the biotechnology sector:
- 1Q1: Conducting Internal Audits
- 2P7: Clinical Trial Regulations for Sponsors (GCP & GMP)
- …
Why choose Qualilab
The experience of Qualilab’s consultants in supporting innovative structures in their R&D projects, combining statistical tools and strict risk control, ensures the level of compliance required for the intended applications.
Our team provides essential recommendations to ensure the compliance of biotechnology operations and products, while also encouraging future innovations.
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.
