Dedicated Regulatory Procedures Team
At the heart of everything we do is regulatory affairs. We understand our clients’ need for their products' route to market to be as smooth as possible: this requires us to have the relevant EU regulatory knowledge at our fingertips, so that we can advise on the optimum regulatory pathway to follow, and ensure that your technical documentation conforms with the relevant guidelines and meets the required standards. From the earliest stages of drug development all the way through to dossier submission and post authorisation life cycle management, all work carried out by every employee at Cyton is in the context of the regulatory requirements.
The work of Cyton’s dedicated regulatory procedures team can be categorised as shown in the panel to the right. Follow the links to find out more about how our team can support your regulatory department, whether that means assisting with specific projects or working more closely with your company - see our key person cover page.
Our technical teams
The regulatory procedures team also acts as the hub from which the work of our technical teams, for pharmaceuticals and immunologicals, is coordinated in preparation for regulatory submissions. Communicating progress and timelines internally, with our clients and their business partners facilitates efficient working practices and allows for crucial project deadlines to be met.
Scientific writing for dossiers and reports
- Preparation of the dossier sections for the administrative and summary parts, and the quality, safety and efficacy documentation (Parts 1, 2, 3A, 3B and 4)
- Detailed and Critical Summaries (DACS, previously Expert Reports), including tabular summaries for Parts 2, 3A, 3B and 4
- Preparation of Expert Reports and Statements to support renewals, variations and line extensions
- Preparation of responses to questions during the assessment process
- Risk Benefit Assessments
Expert representation at authority meetings and oral explanations
- Pre-submission meetings and negotiations with the Competent Authorities to discuss technical aspects of data to be submitted
- Expert support for oral hearings and referrals
- Scientific Advice and Innovation Task Force briefing documents
- Provision of advice and support relating to MUMS classification and applications