The rapidly changing and complex regulatory environment in the global medical devices industry has resulted in the need for organizations to strengthen their safety and risk management practices and improve their core set of expertise, all while reducing their operating model costs. Traditional operating models are being pushed to the point of breaking because of cost pressures, emerging competition, governmental and political demands and the weight of supporting global distribution channels. Not knowing what you don’t know, managing the complexity of the process, lack of specialists and resources and the ability to manage spikes are key issues medical device companies are facing from development to post-marketing monitoring.
From strategic planning and regulatory oversight to managing regulatory processes and preparing submissions, our global experience across all device types helps pave your path to market success. Sciformix invests in building cutting edge expertise and delivery models and services which complement our medical device client’s needs. We specialize in scientific knowledge-based processes and provide end-to-end services in a cost effective manner. Our flexible approach also allows you to pick and choose activities within our service portfolio. By offering an integrated product delivery solution approach and leveraging our domain, process and technology expertise, we help our customers:
- Ensure that they meet the ever changing global regulatory landscape and achieve 100% compliance
- Integrate clinical and commercial strategies to prove unique value
- Balance resourcing as your portfolio adjusts to pipeline, regulatory and market fluctuations
- Lower risk and maximize value during product commercialization
- Reveal your product’s value to regulators, payers, providers and patients
- Make “go/no go” decisions through the entire product lifecycle
Learn more about our Safety & Risk Management, Clinical Research & Post Approval Support Services and Regulatory Affairs expertise.