Guiding your product from concept to launch
About Us

We are a key player in the regulatory services sector consisting of well-seasoned professionals with in-depth exposure to practically all aspects of medicinal product development with a primary focus on activities in Europe, North America and Asia Pacific.

 

We pride ourselves in producing custom-made high quality solutions, providing our clients with a tried-and-trusted, practical method to regulatory activities coupled with extensive knowledge and expertise that is second to none. We can work with you either as a high-profile external consultant, advising on overall strategy, or we can act as an extension of your regulatory department, operating on site on urgent in-house assignments.

 

We have well-established working relationships with key assessors and opinion providers at the EMEA, FDA. MHRA and other regulatory agencies worldwide. In addition, our robust, country-by-country intelligence database is maintained on a continuous basis and ensures that we have the most up-to-date knowledge at our fingertips.

 

So whether it is an expert review of core submission documentation or an extensive assignment involving the preparation and finalisation of large dossiers from scratch, we understand the essential demand of flawless finish that will withstand the rigours of any assessor/audit scrutiny.