Quality Assurance
We assess, design and optimise quality systems:
- External supplier audits and internal audits
- Pre-assessment ahead of GMP / GDP inspections
- Design of documentation systems
- Consultancy on CAPA, change control, OOS and risk analysis
- Preparation of annual Product Quality Reviews (PQR) and system documentation
- Drafting of the quality-system documentation (quality manual, technical dossier, procedures, protocols, etc.)
Technical Advice
Scientific and operational advice:
- Development and evaluation of analytical methods
- Stability study protocols
- UNE-EN ISO/IEC 17025 advisory services
- Analytical method transfer
- Optimisation of Quality Control resources
- Drafting of technical documentation
Need an expert second opinion?
We analyse your problem and give you a clear answer, with a realistic action plan.
Request a diagnostic consultationFrequently asked questions
How does an engagement begin?
With a no-obligation initial diagnosis: we listen to your need, analyse the situation and present a proposal with a clear scope, deadlines and deliverables.
Can you help us with an imminent AEMPS inspection?
Yes. We run a pre-assessment that simulates the GMP or GDP inspection, identify weak points and help you prepare the corrective action plan (CAPA) before the authority's visit.
Do you work with companies outside Spain?
Yes. We carry out international supplier audits and regulatory projects before European authorities, remotely or on site.
Do you offer one-off or ongoing support?
Both. We can solve a specific project or accompany you over time as an external partner to your quality, technical or regulatory departments.