As part of your Regulatory Strategy, or as a stand-alone service, GPB provide the expertise to assist our clients identify the most effective route to gain market clearance in your chosen country. We understand the frustration, delays and costs associated with regulatory applications and the impact of delayed / lost revenue streams. Equally, we are aware of the uncertain EC-UK environment and what to submit to whom to meet the new EC Regulations.
Founded on our expertise and practice we will, (preferably pre-submission), establish the current status of your Technical Documentation, establish clear plans and routes, prepare / collate the objective evidence of compliance with relevant Regulations / Standards and complete the appropriate submissions to save time and cost.
We support you throughout the application process and as appropriate liaise with the Notified Body or other regulatory authority on your behalf, assist in the definition of controls for Launch / Distribution and manage your change notifications.