We are really glad to say, that we participate in developing and and providing Life Sciences experts to some of the world's most prestigious corporations as now we focus on three commercial sectors: pharmaceuticals, biotechnology, and medical equipment.
The pharmaceutical and medical device companies have a duty to comply with new requirements.
- Master the regulatory challenges associated to the emergence of mixed goods by qualifying and validating the impacted production and distribution networks.
- Consider anticipated future needs, such as aggregation.
Every medical equipment has the potential to be connected. Some are already linked and working through programs that give decision support, diagnostic options, and automated therapy management to health professionals and patients. Telemedicine, addiction management, and chronic illness management are just a few of the applications.
- Develop this embedded software in accordance with the target market's regulatory criteria.
- Prove the goods' regulatory compliance, which is difficult owing to the criteria for DM (Medical Device) classification and the existence of software.
- Ensure the safety of personal information and the trust of stakeholders.
A combo product is a health product that contains both a medicine and a medical gadget. Similar to embedded software, innovation and technical advancement are making this form of partnership more and more practical, with a wide range of applications. The combination of hip replacement with antibiotics, which attempts to limit bacterial adherence, is one that has become frequent.
- To design a registrable mixed product, master both the normative limitations of DMs and those of medicines.
- Validate the production process for these hybrid items.
- To ascertain the necessary regulatory status and submit for registration, you must be able to qualify and categorize the combined product.