Whether you are a new start-up company with a new discovery/invention, wanting to persuade a large investor/company of the merits of its commercialisation or a medium or large bio/pharmaceutical company about to file a new or in licenced product with the regulators, being able to give a coherent account in the regulatory documentation is essential.
Current inventions in the healthcare sector are more and more complex and their construct evermore multi-disciplinary. Concurrently the distinction between drug and device is becoming ever more blurred.
The recent acceptance of the final draft of Medical Device Regulations and IVD Regulations and their passing into European law replacing Medical Device and IVD directives respectively means that the regulatory framework is now defined more clearly.
In parallel the new version of ISO13485:2016 to support the changing regulatory landscape requires greater vigilance by the companies in terms of their compliance requirements.
With experience gained working in over 100 high technology projects in Medical Devices and Bio/Pharmaceuticals with many different organisations ranging from small start-up companies to large pharmaceutical giants Pirus Consulting can help you negotiate the regulatory hurdles to bring your invention/product to market.
Pirus consulting has a highly technical approach to understanding your technology. We can help you define the regulatory pathway for your product and devise the appropriate Quality Management System and regulatory approach to take your product to market efficiently.