Challenges facing the Pharmaceutical and Medical Sector
The Life Sciences industry is undergoing profound changes; as a result, its players are regularly confronted with new challenges.
Manufacturers are seeking to anticipate market and technology changes by investing massively in R&D, improving manufacturing processes, strengthening supply chain security, complying with regulatory constraints and improving economic profitability.
Thus, in order to expand, companies must learn to re-invent themselves, control risks and improve their business models while focusing on patient safety and product efficiency.
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Antaes guidance and support
Antaes works with a team of consultants specialized in the fields of pharmaceuticals, food, cosmetics, chemistry, biotechnology, medical devices, and laboratories. Our consultants provide organizational, technical and industrial support on the following points:
- Quality-by-Design approach to Engineering and IT issues: product lifecycle management, risk analysis, quality management
- Data integrity management in accordance with the latest regulatory recommendations (WHO, PIC/S), process analysis implementation (BPMN), quality and information systems management.
- Program / project management including business expertise on the setting up of production entities, corporate information systems, Track and Trace, etc.
- Validation of computerized systems; validation of processes in accordance with applicable regulatory requirements and best practices
- Design and development of dedicated or shared e-Health solutions. Intranet/Internet/Extranet, standard Web technologies
- Preparation of regulatory audits and supplier audits
A Word from the Expert
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Thanks to their deep knowledge of regulatory requirements and their experience in supporting various projects – R&D, supply chain and IT in the pharmaceutical industry, the Antaes team of consultants can guide and support you in your projects to ensure their success both technically and in terms of compliance with the highest quality requirements.
The Antaes method
Antaes proposes an integrated approach from the diagnostic phase to the final validation of the solution.
Our approach is multidisciplinary and respectful of the culture, people and processes already in place. Experts in the regulatory field, in GxP quality systems, and in technical areas, our teams of consultants draw on their extensive knowledge and expertise throughout the project cycle.
Let's talk about your plans
Our teams of experts are at your disposal to listen to you and offer you guidance