- Safety/ tolerance of pharmaceutical products
- Dose determination and confirmation efficacy studies
- Pharmacokinetic and residue studies
- Endoparasitological and ectoparasitological investigations
- Salmonella studies in poultry
- In-feed studies with specific expertise with pigs, poultry, game birds and horses
- Maintenance and supply of various nematode isolates, laboratory strains
and recent field isolates and of Fasciola hepatica metacercariae
- Equine faecal egg count service to guide horse owners and
veterinarians in appropriate anthelmintic use
- Project design, study management, report preparation
- Data collection form development and preparation
- Quality assurance available
- Development of animal models including ectoparasite home
environment, obesity, endoparasite infection, mastitis infection
- Discovery and development projects, safety, efficacy, PK projects
- Palatability studies
- Endoparasite and ectoparasite studies
- A wide range of laboratory reared ectoparasites are available
including Ctenocephalides felis, C. canis, Ixodes spp.,
Rhiphicephalus spp., Dermacentor spp.
Cyton provides in-depth EU regulatory expertise for veterinary medicines covering all therapeutic classes, target animal species, product types and delivery routes.
A team of veterinarians, toxicologists, chemists, pharmacists and biologists with more than two decades of experience working on manufacturing (CMC), safety and efficacy project support. In product development we specifically offer:
- Pharmaceutical / manufacturing & quality projects
- User safety risk assessments
- Establishment of Maximum Residue Limits (MRLs)
- Ecotoxicology projects (Environmental Risk Assessments)
- Preclinical & clinical (Efficacy) projects
- Bioequivalence & generics projects
A dedicated regulatory procedures team co-ordinates the activity of the scientific team to provide services in EU regulatory strategy, product approval procedures, up to and including post approval life cycle maintenance. Specific services supplied are:
- Data gap analysis / dossier audits Analysis of general data packages, or dossiers prepared for non-EU authority review, with detailed commentary to direct any necessary additional studies or data sourcing.
- Dossier preparation Detailed and Critical Summaries (formerly Expert Reports) and scientific opinions, preparation of all sections of the Marketing Authorisation Applications (MAA) dossier and compilation of fully compliant e-submissions.
- Novel technologies Experience with the development and registration of DNA/gene technologies, stem cell products, and many other novel therapies.
- Regulatory submissions Extensive experience of MAAs via decentralised (DCP), mutual recognition (MRP), Centralised (CP) and National Procedures.
- Regulatory intelligence & strategic planning Advice on the best route to market for pharmaceuticals, immunologicals / vaccines, feed materials / feed additives, borderline products / general care products, and new therapies.
- Life cycle management Expertise in all post-marketing and licence maintenance activity, from individual procedures to full life cycle management for a product or product range. We can also provide formal cover for your company’s regulatory team members, with our key person cover.
- Pharmacovigilance Tailored services from the preparation of a single PSUR to complete outsourcing of all Pharmacovigilance responsibilities.
- Quality assurance and GMP Our QA capabilities range from Quality Management Systems and writing of SOPs, to independent GMP audits of manufacturing facilities prior to official inspections.
- Professional training Delivery of regulatory training courses and bespoke training by prior arrangement.
- GLP and GCP studies
- Capacity and expertise for poultry, cattle, swine, rabbits and bee studies
- French CIR accreditation
- Human resources consisting of four veterinarians; one chemist; two biologists;
one quality assurance officer and three technicians on staff
- GLP services include residue depletion studies in edible tissues;
Pk/ADME/bioavailability studies; bioequivalence studies and
target animal safety studies
- GCP study capacity covers dose determination; dose confirmation;
poultry field and poultry challenge in isolates
- Ancillary services include investigator, monitor, QA, statistical input
plus assistance with dossier development and application with EU regulators
- Specific laboratory services include single and repeat dose toxicity;
target organ toxicity; spread and dissemination; antibody by ELISA;
PCR method validation; increase in virulence and overdose toxicity