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Pigs

Our Affiliates

Ridgeway Research Ltd

  • 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

NorthWest Biopharm

  • 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 Biosciences Ltd

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.

Vetspin

  • 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

If you’re interested in the services of any of our affiliated companies we can put you in touch with the right people fast – please Contact Us