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Assentra Ltd | Regulatory Support for Veterinary Medicines and Vaccines

After almost 30 years as a veterinary surgeon in various technical roles in corporate Animal Health, latterly and most importantly in regulatory affairs, I am pleased to offer my experience and expertise to a wider clientele, through ASSENTRA Limited. My objective, through ASSENTRA, is to provide quality independent regulatory support for veterinary medicines and vaccines to the Animal Health industry in Europe. ASSENTRA Limited: RA ASSENT for your Animal Health business. Director, ASSENTRA Limited.

http://www.assentra.com/

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After almost 30 years as a veterinary surgeon in various technical roles in corporate Animal Health, latterly and most importantly in regulatory affairs, I am pleased to offer my experience and expertise to a wider clientele, through ASSENTRA Limited. My objective, through ASSENTRA, is to provide quality independent regulatory support for veterinary medicines and vaccines to the Animal Health industry in Europe. ASSENTRA Limited: RA ASSENT for your Animal Health business. Director, ASSENTRA Limited.
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3 challenges
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6 lifecycle management
7 regulatory issue resolution
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Assentra Ltd | Regulatory Support for Veterinary Medicines and Vaccines | assentra.com Reviews

https://assentra.com

After almost 30 years as a veterinary surgeon in various technical roles in corporate Animal Health, latterly and most importantly in regulatory affairs, I am pleased to offer my experience and expertise to a wider clientele, through ASSENTRA Limited. My objective, through ASSENTRA, is to provide quality independent regulatory support for veterinary medicines and vaccines to the Animal Health industry in Europe. ASSENTRA Limited: RA ASSENT for your Animal Health business. Director, ASSENTRA Limited.

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Regulatory Issue Resolution | Assentra Ltd

http://assentra.com/services/regulatory-issue-resolution

Crisis and issues management. Bring an experienced regulatory expert into heated and urgent situations. An independent, outside view can help keep focus and perspective in pressured environments, and make the most of the regulatory imperatives and opportunities. Problem analysis and strategic plans:. Negotiations with regulatory agencies. Sometimes you just don’t have enough expertise in house to get the job done in time; we provide reactive and flexible expertise, working to your deadlines.

2

Services | Assentra Ltd

http://assentra.com/services

Lifecycle Management Support For Veterinary Vaccines And Pharmaceuticals. Geographical and line extensions. Dossier compilation, revision. Critical summaries and expert statements. Planning, managing procedures. Crisis and issue management. Problem analysis and strategic plans. Adverse Event investigation and reporting. Periodic Safety Update Reports. PV Data resource optimisation. European and National regulatory environments. Public information research and analysis. Website by Douglas G Blane.

3

Challenges | Assentra Ltd

http://assentra.com/common-issues-and-challenges

Regulatory Lifecycle Management for veterinary products is resource demanding and deadline driven, with competing business priorities and regulatory imperatives. Complex issues and demanding regulators stretch experienced regulatory staff capacities, increasing the risk of missing deadlines or inadequate submissions. ASSENTRA Limited: Expert and experienced support. When you need it, so you can focus your team’s resources and expertise to better meet your challenges. Website by Douglas G Blane.

4

Pharmacovigilance | Assentra Ltd

http://assentra.com/services/pharmacovigilance

Qualified Person for Pharmacovigilance (QPPV/Deputy QPPV): pharmacovigilance support for SME Marketing Authorisation holders; take the pressure off internal experts in this crucial area. Adverse Event investigation and reporting:. Veterinarian with Pharmacovigilance experience, independent AE investigation, handling and reporting through your database or EVWEB. Periodic Safety Update Reports. PSUR drafting to NTA Volume 9B requirements based on your PV data and literature review.

5

About Us | Assentra Ltd

http://assentra.com/about-us

ASSENTRA Limited was founded in April 2012 after veterinary surgeon Paul Cooper left Merial SAS, following a career spanning three decades in varied technical roles in May and Baker, Rhone Mérieux and Merial. Paul’s most recent corporate responsibility was setting up and leading Merial’s European Lifecycle Management department. Member of the Association of Veterinary Consultants. Committee Member, Membership Secretary of Association of Veterinarians in Industry. TOPRA); Coordinator of TOPRA VetSpin Group.

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Association of Veterinary Consultants - AVC

http://www.avc.at/avc-listofmembers.asp

The list of members of the Association of Veterinary Consultants provides also information on the areas of expertise of each member. There may also be other fields in which they have a certain degree of expert knowledge. However, only those areas are listed in which full expertise and service in the broadest sense can be guaranteed, both technical and organisational. Phone / Mobile / Fax. Via della Divisione Torino 113. 00143 Roma, Italy. Phone: 39 06 811 075 20 - 22. Fax: 39 06 811 075 21. Marketing (An...

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Assentra Ltd | Regulatory Support for Veterinary Medicines and Vaccines

After almost 30 years as a veterinary surgeon in various technical roles in corporate Animal Health, latterly and most importantly in regulatory affairs, I am pleased to offer my experience and expertise to a wider clientele, through ASSENTRA Limited. My objective, through ASSENTRA, is to provide quality independent regulatory support for veterinary medicines and vaccines to the Animal Health industry in Europe. ASSENTRA Limited: RA ASSENT for your Animal Health business. Director, ASSENTRA Limited.

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