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Buyer's Guide - CROs

Klifovet AG

Geyerspergerstr. 27,
D-80689 München,
Germany
Tel: +49-89-5800820
Fax: +49-89-58008215

Contact: Dr. Klaus Hellmann
www.klifovet.com

 

Located in the center of Europe, thinking globally: Klifovet AG is a Munich/ Germany-based veterinary CRO providing the animal health and animal nutrition industry with services covering all aspects of product development of veterinary medicinal products and feed additives:

• Strategic consultancy: partner search and project management for the complete product development phase: from the idea to the market

• SME, MUMS, scientific advice: we assure that you enjoy all justified benefits

• Regulatory consultancy: analyses and strategy, expert reports, negotiations with the authorities, dossier writing, electronic submissions

•  Pharmacovigilance services incl. QPPV and life cycle management

•  Studies: Planning and conduct of EU GLP/GCP-compliant veterinary safety and efficacy studies in all target animal species

•  QA and QM: Quality assurance and management including audits to GCP, GLP and GMP

•  Data entry, data management and statistics

•  Electronic Data Capture: STUDYBASE®, the validated study management software exclusively made for animal studies

•  Import and manufacturing of veterinary medicinal products and clinical study supplies to GMP: re-packaging, labelling, storage, EU QP release

•  EU representation as Qualified Person for GMP (QP) and Qualified Person for Pharmacovigilance (QPPV)

•  Seminars and trainings

KLIFOVET is certified to ISO 9001, holds EU-GMP accreditation and fully complies with VICH GCP. KLIFOVET won the prestigious Animal Pharm Award twice in 2006 (Best Supporting Role) and 2016 (Best CRO), showing our long term excellent performance for our clients.

CEBIPHAR

Member of the Teranga group.
-
1 rue de la Bodinière,
37230 Fondettes,
France
Tel: +33 (0)2 47 42 48 48

Oliver Roy: oroy@cebiphar.com
www.cebiphar.com

 

Do you need to develop and ensure Life Cycle management of your veterinary drugs, biological, zootechnical & food products?

CEBIPHAR is your trusted partner for:

Multi-site clinical trials for farm & companion animals (according to GCP principles): efficacy, safety, palatability, microbiological studies

On site experimental studies:

TAS, PK, residues, Minimum Inhibitory Concentrations (MIC), Minimum Bactericidal Concentrations (MBC), etc.

Animal models: Large portfolio of models encompassing the major diseases of livestock (lactating cow, cattle, pre-ruminant calves, sheep, swine, poultry, rabbit...) allowing the evaluation of a variety of products (vaccines, antibiotics, NSAIDs, etc.)

 

Five reasons you can entrust your projects to CEBIPHAR:

1. People: Experienced staff dedicated to your project

2. Expertise: Over 37 years of experience and more than 800 studies performed

3. Comprehensive services:
- Strategic advice & project management, for both preclinical & clinical studies
- Regulatory consultancy: audit of dossier, regulatory support, writing of parts III & IV
- Laboratory services: analytical development, VICH stability studies, QC, microbiology (microbiological assay of antibiotics, MIC, MBC, collection of field strains)

4. Animal facilities:
- On-site experimental facility adapted to multiple animal species
- Partnership with INRA (French National Institute for Agricultural Research) for confinement studies

5. Rigorous quality system & GLP-GMP accredited environment

 

Contacts:

Olivier ROY, Director of Veterinary Preclinical and Clinical Department: oroy@cebiphar.com

Stéphanie BURGER-PRIN, Marketing & commercial Director: sburger-prin@cebiphar.com

Clinvet

Uitzich Road, Bainsvlei
Bloemfontein
9338
South Africa
Tel: +27 (0)51 445 2424

enquiry@clinvet.com
www.clinvet.com

 

Clinvet is a GCP/GLP accredited Contract Research Organisation (CRO) established in 1999 and specialises in the conduct of laboratory and field-based efficacy, safety and metabolism trials for veterinary health products.

Since inception, Clinvet has conducted more than 1300 studies aiding in the discovery, development and registration of veterinary products worldwide.

Clinvet has two large state of the art research facilities in South Africa and Morocco.

Services offered by Clinvet:

Laboratory in vitro and in vivo efficacy studies as well as safety and metabolism studies for animal medicine. We maintain an extensive bank of parasites (helminths and arthropods) originating from the US, EU and Africa for use in challenges on companion and production animals. Test animals frequently used include rats, rabbits, cats, dogs, goats, sheep, cattle and horses. We offer the following studies:

• Glass vial contact assay

• Artificial membrane feeding assay

• Proof of concept efficacy

• Dose determination and confirmation

• Parasite challenge efficacy

• Bioequivalence

• Pharmacokinetics

• Residue depletion

• Target animal safety

 

Clinical trial conduct as well as the following support services for animal clinical field and laboratory studies:

• Project management, monitoring and quality assurance

• Protocol, report writing and case report form (CRF) design

• Electronic database, design and validation (EDC/Paper)

• Data management, biostatistics and statistical programming

• Serological (IFA and ELISA) and molecular (qPCR and PCR) diagnostic testing

• Specialised molecular assay development

• Animal genetic profiling, parentage and mutation screening

• Genomic analysis of parasites

ERAvet

Neue Straße 23
26316 Varel
Germany
+49 (0)4451 / 9182040

Contact: Dr. Michael Lammers, M.D.R.A.
michael.lammers@eravet.eu
www.eravet.eu

 

Founded in 2011, ERAvet has established itself as one of the leading Animal Health consultancies in Germany. We now serve 35 % of the active animal health companies in our domestic market including global corporations as well as small and medium-sized enterprises.

Regulatory strategy, regulatory project management and the safety part of the dossier are our core in-house competencies and our company’s growing reputation has increasingly earned us opportunities to participate in a wide range of challenging projects across Europe. So far ERAvet has managed and contributed to more than 25 successful application procedures resulting in nearly 300 marketing authorisations.

ERAvet offers full pharmacovigilance services including QPPV responsibility and establishment/ maintenance of pharmacovigilance systems according to European standards. We have processed thousands of cases and have expertise in small and medium-sized pharmacovigilance systems as well as global pharmacovigilance processes.

We keep our organisation slim, ensuring efficient processes and competitive rates. Our very committed in-house staff works closely with you while our dedicated network of professionals provides all the required additional scientific disciplines and services. You get a single-source solution from a highly efficient team put together especially for your project.

If you are seeking regulatory intelligence or highly experienced additional capacities, ERAvet is the partner you are looking for.

Löhlein & Wolf Vet Research

Löhlein & Wolf Vet Research
Ickstattstr. 5
80469 München
Germany
Tel: +49 89 2300 0123
Fax +49 89 2307 6763

Contact: Oliver Wolf and Wolfgang Löhlein
info@vet-research.com
www.vet-research.com

 

Löhlein & Wolf Vet Research is a contract research organization specialized in veterinary clinical field studies conducted in Europe.

Studies

GCP and non-GCP studies in companion and farm animal species, poultry and minor species.

Services

Project management, monitoring, medical writing, translations, selection and set up of study sites, material and drug logistics and management, test permits, QA, data management and statistics, reporting and electronic data capture (Löhlein & Wolf EDC and third party EDC solutions).

Quality

Full featured and audited quality management system. Providing high quality services with a maximum of flexibility.

Network

Strong network of experienced partners, veterinarians, farmers, specialists, clinics and laboratories.

Contacts

Oliver Wolf and Wolfgang Löhlein

BioMedVet Research GmbH

Südkampen 31,
29664 Walsrode,
Germany
Tel: +49-(0)-51-66-931-98-0
Fax: +49-(0)-51-66-931-98-29

Contact: Dr. Holger Schmidt
info@biomedvet.de

BioMedVet Research is an independent and privately owned GLP-certified contract research organisation with core competence in the field of animal health.

We are located in a rural area in Northern Germany facilitating the conduct of studies not only under laboratory but also under field conditions.

Purpose-built facilities are available on site to accommodate all relevant animal species such as rabbits, dogs, cats, pigs, sheep, goats, cattle, horses and poultry.

Our services for pharmaceuticals, biologicals and feed additives include:

  • Pharmacokinetics / Bioequivalence

  • Residue depletion

  • Target animal safety / Tolerance

  • Local tolerance

  • Efficacy (incl. BSL 2 challenge / infection models)

Our efficient organisation ensures short communication lines, a flexible customer-oriented approach and services tailored to the individual requirements of the product.

IDEXX BioResearch

IDEXX BioAnalytics
Vet Med Labor GmbH
Moerikestrasse 28/1
71636 Ludwigsburg
Germany
Tel: +49 (0) 7141 64 83 585
Fax: +49 (0) 7141 64 83 584

idexxbioAnalytics-europe@idexx.com
www.idexxbioanalytics.eu/reliable-reproducible-results/

 

From Pilot Studies to Pivotal Trials, you can count on our IDEXX BioAnalytics clinical support team to help you reduce errors, increase sample quality and decrease turnaround times. Our extensive assay portfolio is your advantage – our centralized lab services provide quality; confident results you can trust.

- Dedicated Project Manager

- Global Study Coordination

- Customized Sample Collection Kits

- VICH GL9 expertise

- EDC Software Connectivity

- Study Close-out Support

IDEXX BioAnalytics is your strategic partner for reliable, reproducible results whilst accelerating your research through innovative technologies, logistics support and scientific expertise, so you can confidently improve the health and welfare of people and animals.

A global market leader in diagnostics solutions for animal health, water and dairy quality:

- Over 6,500 global employees

- Over 400 scientists, pathologists and veterinarians on staff

- Over 60 locations worldwide

- Over 280 million invested in R&D in the last 5 years

Moredun Scientific

Pentlands Science Park,
Bush Loan,
Penicuik,
Near Edinburgh,
EH26 0PZ,
UK
Tel:+44 (0)131 445 6206

info@moredun-scientific.com
www.moredun-scientific.com

 

Moredun Scientific, the commercial arm of the Moredun Group, is a GLP accredited contract research organization with over 25 years of experience in conducting efficacy and safety studies in all species of livestock.

Disease Models: our broad portfolio of infectious disease models coupled with the ability to develop and validate new models supports the registration of veterinary vaccines, anti-infectives, anti-parasitics and feed additives.

State of the art animal facilities: GLP accredited animal accommodation ranging from conventional farm accommodation, to specific pathogen free (SPF), Category 3 containment or gnotobiotic units.

Laboratory facilities: we can support all aspects of safety and efficacy studies.

Target animal safety studies: we conduct safety and tolerance studies in compliance with relevant international guidelines for pharmaceuticals, biologicals and feed additives.

Rigorous quality systems: our independent Quality Assurance department has expertise in GLP, VICH-GCP and GMP. All studies are conducted to meet regulatory guidelines.

Access to relevant expert scientists: internationally recognised scientists within the Moredun Group provide unique guidance to advance projects.

 

Amatsigroup

AMATSIGROUP
EU: Parc de Genibrat, 31470 Fontenilles, France
USA: 2458 N. Chamberlain St., Terre Haute, IN 47805
EU - Tel: + 33 (0)5 6214 7184
USA - Tel: +1 812 877 1009

sales@amatsigroup.com
http://www.amatsigroup.com

Amatsigroup is a leading Early CDMO (Contract Development and Manufacturing Organization) with over 15 years of experience in veterinary product development.

 

WE PROVIDE:

  • BIOSERVICES (In life studies and Bioanalysis): PK and ADME studies, Safety studies (residues, TAS), some efficacy models

  • PHARMACEUTICAL ANALYSIS SOLUTIONS (Development & validation of analytical methods, VICH stability studies, Contract cGMP QC)

  • FORMULATION DEVELOPMENT & MANUFACTURING (small-batch-focused)

  • CLINICAL TRIAL SUPPLIES (Packaging, GMP storage, QP release, experience with distribution of IVPs to clinical sites)

Under GLP and GMP environment (EMA, FDA compliance).

 

OUR KEY ASSETS:

  • Facilities for farm and companion animals both in the US and in France  (total 7 400 m2 / 80,000sq ft)

  • Experience working with over 80 marketed veterinary products

  • AAALAC accreditation

  • 6 D.V.M. on site

  • In life & bioanalytical capacities at the same site in France

  • Option for full project management supported by our CMC-RA team

  • Mastering both US & EU veterinary guidelines

 

OUR ADDED VALUES:

  • Optimization of development timelines by managing project continuum

  • Maximization of regulatory validation by providing reliable data and thorough reports

 

Veterinary Research Management Ltd

Veterinary Research Management Ltd,
The Mews Studio,
Portland Road,
Malvern, Worcs
WR14 2TA
UK
Tel: +44 1684 568998 or
+44 7968 696683

info@vrm.uk.com
www.vrm.uk.com

Specialists in research management with proven expertise in project delivery. Our services include:

• Project management • Registration expertise - NCE’s & generics • Dose optimisation • GLP/GCPv compliant test facilities • Dose determination, dose confirmation, safety, efficacy, residues, bioequivalence & pK studies in livestock & companion animals • Specialist parasitology expertise & parasite supply • Multi-country field studies • In vitro studies • Scientific writing - peer reviewed publication, editorials, expert statements, study reports & regulatory defence •

VRM Ltd also represents Ridgeway Research Ltd (UK), Invetus Pty Ltd (Australia), Northwest Biopharm Ltd (Ireland) and Cyton Biosciences (UK). Affiliations with these other organisations provide VRM with direct access to first-class test facilities across the world and an expert team of interdisciplinary scientists, to draw on as appropriate to deliver your project.

Triveritas

Head office: Bank Barn,
How Mill,
Brampton,
Cumbria,
CA8 9JY
UK
Tel: +44 (0) 845 123 2888

info@triveritas.com
www.triveritas.com

A global CRO offering state of the art technological data management resources in AH clinical studies. Triveritas Electronic Data Capture System, from Prelude Dynamics, is a web-based EDC system compliant with 21 CFR 11. From the input to the output of data, our comprehensive data collection form library offers adaptable solutions for specific study requirements and designs.

Our flexible approach uses innovative strategies to address timelines and budget.

Expertise includes: Full Product Development; VICH GCP Clinical Studies; Regulatory Affairs; Strategic Advice; Quality Assurance (GxP); Training; Project Management and Pharmacovigilance.

Vetspin

Vetspin S.r.l.
Via Tolara di Sopra,
5040064 Ozzano dell'Emilia (BO)
Italy
Tel: +39 (0)51 2097500

infoservice@vetspin.com
www.vetspin.com

Vetspin is a GLP and GCP accredited CRO specialised in studies of safety and efficacy on farm animals, including cattle, pig, sheep, poultry (chicken, turkey, duck, guinea fowl) and rabbit.

  • Target animal safety, pharmacokinetic, residue depletion,
    dose determination on infected animals.
  • Development and validation of analytical methods for
    veterinary drugs on plasma, tissues (liver, kidney, fat, fat+skin,
    muscle, other tissues), milk, eggs, manure.
  • Data Analysis (Biostatistics).
  • Regulatory affairs: Dossiers, Expert Reports.

 

Charles River

Charles River has been supporting the development of animal health products for over 40 years. We offer a full range of target animal, preclinical and clinical studies, tailoring our services to meet client requirements.

Our full portfolio of preclinical studies includes absorption, distribution, metabolism and excretion (ADME), pharmacokinetic, bioequivalence, residue depletion and target animal safety studies. Our purpose-built facilities have been designed to house all relevant food-producing species and can also accommodate radiolabelled studies.

Our studies are performed in accordance with the necessary guidelines (GLP, GCPv, VICH, etc.) and are supported by quality assurance, chemistry, toxicology, parasitology, ecotoxicology, environmental fate and veterinary pathology, including immunohistochemistry and specialist staining capabilities.

Charles River has clinical expertise in both farm animal studies and companion animal studies. We have performed a wide range of study types and our experience includes efficacy, tolerance, dose determination, reproductive safety, vaccine and challenge studies, with a special interest and expertise in parasitological and microbiological studies. In addition, we have comprehensive experience managing multi-site clinical trials throughout Europe in both livestock and companion animals.

Quality data, and their timely delivery, are critical to the efficient development and successful registration of animal health products. The full integration of in-house analytical support enables Charles River to fully meet regulatory endpoints and respond to the needs of our clients.

With facilities in Europe (UK and Ireland) and throughout North America, we offer a comprehensive global service to the animal health industry.

Farma Research Animal Health B.V

Toernooiveld 300-H,
6525 EC Nijmegen,
The Netherlands
Tel: +31 (0)24 350 55 74

Contact: Hans van Hattum
info@frah.nl
www.frah.nl

Farma Research Animal Health B.V.: an independent, GLP accredited, CRO. More than 25 years specialised in the performance and organisation of veterinary projects:

Test products

Veterinary medicines, Feed additives

Quality

GLP

VICH-GCP

Studies

  • Preclinical studies
    bioequivalence, tissue residue, milk residue, target animal safety, pharmacokinetic, dose determination/confirmation, etc

  • Field trials
    efficacy, safety

Target species: dog, cat, (dairy) cattle, sheep, horse, pig, poultry, birds.

Bio-analytics

Plasma, tissues, milk, egg, faeces, etc.

Regulatory affairs

Consultancy, dossiers, expert reports

Pharmacovigilance

QPPV, PSUR, DDPS

Guidelines

Projects according to actual EMA and VICH-GCP Guidelines

Ondax Scientific

ONDAX Scientific SL
Aptdo. 336
20280 Hondarribia
Gipuzkoa
Spain
Tel: +34 943 646 087
Email: +34 943 646 158

Contact: Patxi Sarasola
ondaxhq@ondax-scientific.com
www.ondax-scientific.com/

The European Specialists in Clinical Trials

Local Expertise with a Global Approach

ONDAX Scientific is an independent Contract Research Organisation (CRO) specialised in providing Europe-wide Clinical Trial Services to the animal health industry. Our Clinical Trial Services include: test permit applications, study set-up, trial monitoring, auditing, data entry, data analysis and study report writing both in companion animals and livestock. We are highly experienced conducting a wide range of field studies to evaluate the efficacy and safety of Pharmaceuticals and Biologicals both at national and multinational level in several therapeutic areas.  We operate in a highly responsive, flexible manner to suit Sponsor requirements meeting targets in a timely and cost-effective manner.

Our Services include:

Clinical Trials:

  • VICH GCP

  • Pharmaceutical Trials

  • Biological Trials

  • Novel Therapies

  • Companion Animal Trials

  • Livestock Trials

  • Multicentre Trials

  • Test Permits

  • Import licences

Data Management:

  • Database Design and Validation

  • Electronic Data Capture (EDC) and Paper based studies

  • Data Management Activities and Consultancy

Biostatistics:

  • Statistical Input and Design

  • Randomisations

  • Statistical Analysis

Quality Assurance:

  • Site Audits

  • Master File Audits

  • Database Audits (paper and EDC)

  • Systems Audits

To find out more (including therapeutic areas) please visit: www.ondax-scientific.com/

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