Are you developing a new medicine or medical device?
Are you aware of the EU regulatory approval process?
Universities, independent research laboratories and spin-off start-up enterprises play an increasingly important role in the development of new drug and medical technology products. However, their scientific innovation may not always be backed up by knowledge of the procedures required to obtain European regulatory approval for their products. Innovator Support is our response to this.
Mistakes can lead to costly delays
Because of the stringent European Union (EU) legislation around medical products, approval must be sought from the Regulatory Authorities at each step of the development process.
The procedures are complex and any mistakes can lead to project delays and considerable additional costs. Real Regulatory has substantial experience in helping universities and small start-up enterprises to develop their products in accordance with EU regulatory requirements, thus adding value for onward out-licensing deals or helping to bring these new products to market.
We leave you free to concentrate on product innovation
Innovator Support takes the burden of regulatory approval off your shoulders, leaving you free to concentrate on product innovation:
An initial review sets out the regulatory guidelines and flags potential barriers to approval
Strategic planning and process mapping at the initial stages support early approvals
Periodic reviews make sure your innovation remains on track
We make sure the documentation for your submission ticks all the right boxes
We liaise with and respond to any queries from the EU regulators, acting as their first point of contact
Once regulatory approval has been achieved, our team will make sure you maintain regulatory compliance
Once marketing approval has been achieved, we will help transform your innovation into a commercial reality.
A flexible, virtual team approach
We supplement our own specialist services with support from our panel of product development experts, including clinicians, toxicologists and statisticians. They will be experts in your therapeutic area, in product usage as well as EU regulatory requirements. This virtual team approach is an efficient and flexible way to support the product development process.See our Frequently Asked Questions (FAQs)