Consulting and Training
The speed and safety demanded by the market in all new launches makes it essential to have a highly efficient development process. The performance of all those analyses and controls that ensure the maximum quality and reliability of the product are nowadays necessary from the early stages of development.
Our long experience in analysis and controls allows us to provide our clients with a high level of confidence and security throughout these key stages of development.
Our flexibility and know-how allow us to provide tailor-made solutions that meet the specific needs of each project. This customization allows direct contact between our technicians and the client, which results in optimized response times.
Consulting
Nowadays, due to the rapid technological evolution, it is difficult to keep abreast of new legislation, analysis methods and their implications within the industry. Having experts capable of interpreting and advising on the application of the different regulations and requirements is not an extra, it is a necessity.
In many occasions, unexpected problems arise in the installations and products, being in many occasions complicated to find the causes. Often it is essential to have external support to help diagnose the problem and assist in the implementation of an action plan.
Training:
In search of knowledge
Always, and even more so nowadays, training and recycling are essential for all those organizations that want to keep abreast of new technological and regulatory advances.
As part of its activity, Micro-Bios carries out training plans for companies that request it, in different modalities: general training modules, development and practice of analytical techniques, monographic seminars and specialized forums.
For this purpose, we have theoretical and practical training classrooms in our facilities, which we put at your disposal.
- Regulatory Affairs / Registration Services
- Development and maintenance of QM systems (GMP, GDP)
- Pharmacovigilance
- Clinical and medical evaluation
- Drug/batch release as a service
- Audits (incl. API) and inspections
- Release testing and EU re-testing
- General microbiology
- Chromatographic methods
- Set-up and validation of analytical methods
- Analytical transfer
- Protocol development
- Process analysis
- Customized training topics