Mpect was born because current compliance processes are set up for a reactive approach. We saw a way to fix that approach. Unseating outdated solutions is no small job and it takes a special platform to get it done. Mpect solution is designed from the ground up to maximize collaboration, minimize risk, create a more effective learning process and a compliance approach.
At Mpect our mission is to build a new class of regulatory compliance solutions that are proactive, collaborative and streamline the regulatory process.
The Pharmaceutical and Life Sciences industries are among the most heavily regulated industries in the world. The regulatory environment is continuously changing in response to the effects of globalization and harmonization, emerging markets, increasing complexity of disease targets, introduction of new technologies and the rising sophistication and demands of both patients and regulators.
Yet adherence to regulatory requirements is vital to both a company's and the industry's reputation. Keeping pace with changing regulation requires good processes and procedures which ensure adherence and enable effective global, national and local management. We work with our clients to audit and develop management systems which enable greater transparency across the firm, inform the development of new approaches to a broad range of regulatory compliance, risk management procedures and help improve performance.
However, increasingly firms recognize the need for a new approach. Companies and regulators will need to work more closely together on the future development of rules and regulations for both obtaining market approval and ensuring products remain on the market. Whilst today much of the dialogue between industry and regulators is around safety, efficacy and value for money; in future the discussion will be about providing total health care solutions, improving patient compliance, earlier access to medicines through shortened development cycles, and product development risk sharing arrangements.
MPECT's regulatory compliance solutions help organizations mitigate risks and reduce the complexity of regulated business processes while reducing costs associated with the production, sales, and service of medical devices and diagnostic products.