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Buyer's Guide - Manufacturer

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.

Nordson EFD

40 Catamore Blvd.,
East Providence,
RI 02914
USA
Toll Free: 800-556-3484
Tel: +1 401-431-7000

info@nordsonefd.com
www.nordsonefd.com/AnimalHealth

 

With its 2017 acquisition of Plas-Pak Industries, Inc., Nordson EFD now offers best-in-class Dial-A-Dose™ and Posi-Dose® disposable dosing syringes used for primary packaging and drug delivery of creams, gels, and pastes in the animal health industry. The world’s leading manufacturer of fluid packaging and precision dispensing systems since 1963, Nordson EFD offers worldwide support with offices in more than 40 countries, plus global stocking warehouses and technical support.

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

 

Ashish Life Science Pvt Limited

 

Here to enrich

 

Ashish Life Science Pvt Limited
213, Laxmi Plaza, New Link Road,
Andheri (W), Mumbai - 400053.
India.

www.ashishlifescience.com
bdm.cm@ashishlifescience.com

 

Ashish Life Science (ALS), India, is an Organization with over a decade of experience in veterinary formulation manufacturing. Currently we export to more than 50 countries globally. We are one of the leading Contract manufacturing organization catering to global clients.

Facility Approvals
Manufacturing facility is approved by following authorities:

  • EU GMP
  • APVMA (Australia)
  • All other important African countries approvals.

 

Manufacturing
ALS owns state-of-the-art manufacturing facility located in MIDC, Tarapur, in the state of Maharashtra, 100 km away from Mumbai airport with the following dosage forms:

  • Tablet and Oral Liquid
  • Oral Powder and Oral Paste
  • Sterile Liquid Injections

 

Contract Manufacturing Organization (CMO)
ALS undertakes contract manufacturing for many international and national organizations for the supply of tailor-made solutions.
We provide one-stop solution to all animal health pharmaceutical and nutraceutical products.

Product Development Service
From the product concept, through formulation and development, to production, our team of experts is capable of producing cost effective, high quality products with superior performance by applying modern technology and technical expertise at every step in the process. We not only help our clients to deliver a better product but also help to bring it to market faster. Process of product development is as follows:

  • Formulation and Development
  • Validation of Analytical Methods
  • Stability study conducted according to ICH guidelines.

 

Regulatory Service
As per regulatory guidelines we provide all relevant documents for dossier preparation as per authority's requirements.

Key Service features:

  • EU GMP site for Tablet, Liquid, Oral Paste and Powders
  • CMO business & ready to buy existing M.A.
  • Collaboration with EU partners for site transfer projects & Collaborative product development

 

 

Dechra

Dechra Pharmaceuticals Manufacturing is the manufacturing business of Dechra Pharmaceuticals PLC, operating from two European sites at Bladel, NL and Skipton, UK.

Dechra Pharmaceuticals Manufacturing provides a comprehensive range of contract pharmaceutical services.

Our mission is to provide an excellent service, developing and supplying quality products to our customers worldwide.

We are a complete service provider, offering product development through manufacturing and packing to QP release, supported by highly qualified staff, trained to the highest standard.

The Bladel site is dedicated to veterinary pharmaceuticals and the state of the art, cGMP, IGZ approved facility has a wide range of capabilities from small volume and development scale batches to large volume production for food producing animals.

It manufacturers aseptically filled injections, oral solutions, powders and medicated premixes,  packed into a range of sizes of vials, bottles, sachets and bags.

Ongoing investment in our factory at Skipton, has created a, well equipped, MHRA and FDA approved cGMP facility that produces a diverse range of dosage forms and wide scale of volumes and batch sizes, including scale-up and commercial batch production.

Products produced include tablets, capsules, ointments, creams, gels, liquids and terminally sterilized injections, packed into blisters, pots, sachets, tubes, dispensers, bottles and vials.

As well as the accreditations (listed above) we have achieved certification to ISO 14001 environmental standard, and are licensed to manufacture IMPs, Specials and Controlled Drugs.

The combined sites offer a full range of manufacturing services to the veterinary industry.

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.

MVP Technologies

4805 G Street,
Omaha,
NE 68117
USA
Tel: 800-856-4648
Fax: 1-402-331-8776

mvplabs@mvplabs.com
www.mvp-technologies.com

MVP Technologies is a global adjuvant company that understands vaccines. Because MVP began as a vaccine manufacturer, we have first-hand knowledge in optimizing the desired immune response for numerous antigens and animal species. The company is celebrating its 30th year with a long-standing reputation of excellent product and customer support.

Since its initial development work on EMULSIGENR, MVP has been committed to building on its adjuvant platform by: 1) removing all animal origin components from its products; 2) providing pre-sterilized adjuvants that are ready to add to antigen without use of complex equipment; and 3) expanding its adjuvant line.

MVP now offers not only its premier EMULSIGEN® but also EMULSIGEN®-D, EMULSIGEN®-P, EMULSIGEN® -BCL, CARBIGEN™ and POLYGEN™ The latter two are polymerbased adjuvants. In addition, we provide custom adjuvant manufacturing service for clients.

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