We provide CRO services and pride ourselves in putting your company's needs first and adding value to whatever we do. We employ Lean principles in our strategy and by being science-led we share the passion with the scientific, healthcare and business communities in the UK.

As a group of Regulatory, QA and Pharmacovigilance consultants we offer an array of services for small to medium-sized pharmaceutical companies. As the regulatory landscape is ever changing that extra help may be just what you need. 

-Regulatory Affairs: from Registration throughout Lifecycle maintenance. 
-Publishing: eCTD authoring 
-Pharmacovigilance: QPPV services, PSUR compiling and post-marketing monitoring
-Tracking of regulatory changes and provide updates applicable to Client’s product applications.
-Provide submission services to regulators and Competent Authorities worldwide, electronically wherever possible, through hosted production and document management systems.

-Prepare and submit updates to the Summary of Product Characteristics (SmPC), patient information leaflets, and product labelling.
 
-Complete response to questions received from Health Authorities, particularly those related to product safety that may arise from PSURs and other reports submitted
-Life-cycle submissions and managing agency queries
-Affiliate service provision 
-Publishing capability

Regulatory Affairs Hub

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