The registration of generic veterinary medicines can be complex. Cyton can support you in obtaining Marketing Authorisations for your generic products in the EU and USA.
Demonstration of Bioequivalence
Whether your product requires an in vivo bioequivalence study or a full clinical equivalence package, the preclinical and clinical team, led by experienced veterinarians, will help you select the best CRO and carry out the right studies for your generic product.
Chemistry, Manufacturing and Controls
Our CMC experts are experienced with the design of in vitro dissolution studies meeting the regulatory requirements to support biowaivers and bioequivalence exemptions.
Environmental Risk Assessment
We have unparalleled environmental toxicology expertise within Cyton and knoell; our clients can be confident that even the most complex Phase II EIA will be properly addressed. Find out more here.
Referral Group Support for Class Referrals
Responding to questions asked in a class referral presents unique challenges in terms of data sharing and inter-company co-operation. Cyton has the experience and expertise to provide independent support in the preparation of group referral responses. Find out more here.
Strategic advice
Which legal base (e.g. true generic? Generic hybrid?); Which EU reference product in the case of disharmonised SPCs? Is a BCS biowaiver or bioequivalence exemption applicable? How can you protect you product from generic competition? Cyton can assist you in developing the best strategy for your generic product. Find out more here.
Regulatory procedure management
Cyton’s dedicated Regulatory Procedures Group handles the preparation and submission of the generic EU MAA dossier, and can oversee the procedure through to issue of the MAs. Our experience allows us to anticipate and find solutions to potential challenges. We work with our sister company in the USA, Critical Path Services to provide expertise in ANADA submissions and FDA liaison.
Maximum Residue Limits
We understand the critical importance of withdrawal periods; where bioequivalence does not preclude the need to carry out residue depletion studies, we will ensure that the most competitive withdrawal periods possible are supported. Find out more here.
User Safety Risk Assessment
The safety of all products to the user must be justified and our team of toxicologists have the experience to make sure this is properly evaluated prior to submission. Find out more here.