Extend Your Regulatory Team
Cyton understands the pressures of working in a demanding regulatory environment. At Cyton we have a dedicated team of regulatory experts who can provide professional regulatory support, with specific focus on ‘life-cycle management’.
Where We Can Help
Cyton can provide key regulatory personnel to cover unforeseen increases in workload, holiday leave, sickness or maternity leave. Facilitating clear communication between all parties and using well-defined processes, key person cover is designed to support in the following areas:
- All pre- and post-marketing activities. Regardless of size or timescale, we can add specialist knowledge, implement your regulatory strategy and free up your existing resources
- Management of downstream effects, SPC version control and packaging updates
- Coordination: Cyton can act as the central regulatory and technical point of contact for all stakeholders (Marketing Authorisation Holder, local affiliates, distributors, manufacturers, National Competent Authorities)
When can we help?
We’re here whenever you need us; the point of key person cover is to provide ad-hoc support, as and when you need it, especially at short notice. Keeping to timeframes in the regulatory environment is critical. With this in mind, we appreciate the need to identify and prioritise key responsibilities and deadlines, at the earliest possible opportunity.
Why choose Cyton?
Trust is a major factor to be considered when outsourcing to a consultancy; can you rely on the consultant to effectively replace your key person, even when handling unexpected events? To allow you to have confidence in our services you need to know that Cyton can effectively respond to any issue which may arise. Trust in Cyton’s experience and professionalism and utilise our expertise to support you. See our endorsements page for client testimonials.
Cyton’s dedicated Regulatory Procedures Team ensures that a project manager, single point of contact, is always present. This ensures efficient collaboration with contributing parties and smooth transition across project stages:
- Support from our teams of experts across all technical areas allows for a ‘tailored’ project approach, ensuring you receive the exact level of support you require in any area of regulatory affairs
- Extensive experience with all regulatory procedures, for all routes of application and for all product types (pharmaceuticals, immunologicals, borderline products, animal nutrition)
- Excellent Quality Assurance and project governance assures time/cost/quality constraints are balanced to your needs
- Cyton has experience in working with companies from around the world, from regional SMEs to global multi-nationals. We understand the importance of aligning our working practices with your own. Through the planning and adoption of your own internal procedures, transition to our support will be seamless
Cyton has the experience and expertise to give you confidence in delegating key regulatory support responsibilities on a flexible basis. Streamlined regulatory submission and approval provides a quicker route to profitability; by the same token, delays can increase costs. Cyton can provide support when a project needs to be fast-tracked, or when additional resources are required to meet deadlines. We are proud of the professional regulatory support we provide. Contact us to find out more.