Cyton’s expertise in product development and European regulatory affairs is extended by our network of global sister companies and strategic partners. Read more below and find out just how far our network of experts can take your company.
After 12 years in the Committee for Veterinary Medicines (CVMP) under the European Medicines Agency, including 6 years as Chairperson, Anja Holm has decided to use her expertise in a new way as an independent consultant.
Her mission is to help the Animal Health Industry provide good and effective Veterinary Medicines for the benefit of animals, vets and owners.
- Benefit from her broad overview of the EU regulation of Veterinary Medicines
- Get success with your product in the centralised procedure through CVMP and the European Medicines Agency (EMA)
- Understand all your options and decide the optimal strategy
- Receive robust guidance and help in Oral Explanations, Referrals, Scientific Advice, List of Questions, PSURs, etc.
- Specialised trainings, presentations and meetings
- Expert reports (safety and efficacy)
- Advice on dossier construction and scientific content using globally acceptable studies (VICH)
VRM provides international veterinary clinical research expertise to manage and coordinate your drug development and registration projects, pharmaceutical or biological.
The VRM team designs, manages, & delivers veterinary development projects for global pharmaceutical clients.
Need to place a programme of studies or find expertise? VRM will help.
VRM will work synergistically with your team to accelerate your veterinary medicine to registration and launch by optimizing the use of internal and external expertise and facilities.
VRM is directly affiliated to two global leaders in the conduct of veterinary clinical research trials in the northern and southern hemispheres, enabling year-round conduct of seasonal studies.
VRM will partner with you before, during and after the registration of your product, providing technical solutions to ensure successful commercialisation.
Cyton’s strategic alliance with Steve Houghton, Veterinary Vaccines Consultancy (VVC) means that Cyton offers a comprehensive service for all vaccines, immunologicals and biologicals. VVC’s expertise in development and manufacture complements Cyton’s technical and regulatory experts to provide one team for all product development and regulatory projects.
Our experience covers major species (e.g. dogs, cats, cattle, sheep, pigs, poultry and salmon) and minor species (e.g. horses, rabbits, fish and foxes) and a diversity of product types: live attenuated viral vaccines, live attenuated bacterial vaccines, inactivated viral vaccines, multivalent vaccines, GMO / DNA vaccines, immunosera and in vivo diagnostics.
knoell USA provides expertise on the regulation of veterinary medicines in the USA. Specific services include:
- Drug product label compliance
- Submit ALL relevant regulatory filings to FDA via Electronic Submission Gateway (ESG)
- Serve as U.S. Agent, official liaison between your company and FDA
- Develop customized drug approval strategy: NADA v ANADA v MUMS, BE v biowaiver
- Compilation of full technical sections for phased reviews: CMC, Safety & Efficacy, DMF, etc.
- Highly proficient in SPL and troubleshooting for electronic filing needs
- Gap analysis of existing documentation for cGMP compliance
- Assessment of pivotal safety & efficacy study data
- cGMP auditing and facility audits
Another member of the knoell group, our Shanghai team can support animal health companies seeking product licences in China. Specific services include:
- Expertise in pharmaceuticals, immunologicals and feed additives
- Regulatory support in all stages of veterinary medicines registration in China
- Registration dossier preparation and submission, quality, safety, efficacy
- Audit, communication and negotiation with administrative licensed laboratories in China
- Regulatory toxicology support in China
- Data gap analysis & strategic advice
- Study monitor in China
- Dossier translation