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Buyer's Guide - Regulatory

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.

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.

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

 

Cyton

Cyton Biosciences Ltd.
68 Macrae Road
Eden Office Park
Bristol
BS20 0DD
UK
Tel: +44 (0)1179 739 036

enquiries@cyton.com
www.cyton.com
Twitter.com/CytonBio
LinkedIn.com/company/Cyton-Biosciences

Expertise in depth

Cyton is a full-service animal health consultancy providing specialist multi-disciplinary technical expertise in quality, safety and efficacy, as well as regulatory affairs for the following product types:

  • Pharmaceuticals

  • Immunologicals

  • Feed additives

 

Our clients include 8 of the top 10 global animal health companies and we have an equally broad base of SME clients and start-up companies, giving us a wealth of varied experience and an appreciation of every client's uniqueness.

Our team

Cyton's veterinarians, chemists, toxicologists and regulatory experts are at liberty to work with any global contract research organisation or contract manufacturer, ensuring that product development projects are delivered to match our clients' specific needs.

Global support

Because we understand the importance of local expertise we work closely with our offices in Germany, the USA and China to fulfil our customers' needs and achieve their product registrations in their target markets.

Contact us

Cyton has the technical and regulatory expertise to negotiate any challenges during product development and registration. Please get in touch for a free initial consultation.

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.

Estendart Ltd

Aviation Way,
Poultry Farm Road,
Palmerston North,
4442
New Zealand
Tel: +64 (0) 6 3500770

info@estendart.co.nz
www.estendart.com/

Estendart Ltd is NZ’s leading company for regulatory-based studies conducted to GLP (OECD) and GCP (VICH) standards. Estendart Ltd (est 1986) is alongside Massey University’s Vet School with direct access to the extensive research facilities, farms and veterinary expertise. Proof-of-concept, pre-clinical and clinical studies (multi-site) are undertaken in all food-producing and companion animals. These focus on efficacy, safety and residue (food-producing) evaluations. Services include animal models for the evaluation of medical devices and determination of the toxicology of compounds with biological activity. Estendart provides a full service commencing with arranging the importation of test items, protocol development, quality assurance, statistical analysis and reporting. All studies comply with NZ law on animal welfare. Although based “downunder” we are still only a dotcom away.

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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