VETERINARY
Veterinary
Origo can support your project journey from start to finish as well as provide specific services as per customer needs. With our expertise in veterinary product areas including novel delivery systems, you can be assured of quality products in a fixed timeline.
1. Product manufacturing Services provided include consulting services for: • Process -Manufacturing and Packaging • Process and Equipment Validation • Equipment Cleaning Validation • Product Analysis and Method Validation • Sterility and Stability Testing • Quality Control • Master Production Records • GMP compliance and related documents (drug master files, product label review) • Site Inspections • Standard Operating Procedures Origo provides support in the review, preparation, and submission of the chemistry, manufacturing, and controls (CMC) section of New Animal Drug Applications (NADAs) and Abbreviated NADAs. We provide product-specific guidance for: • New Product Identification and Forecast • Technical Evaluation of New Products and Innovations • Marketing Strategies for Rejuvenating an Existing Brand • Mock Inspection of Manufacturing sites for Animal Drugs & Diagnostics
2. Veterinary Research Consulting services are provided for: • Monitoring of Safety and Efficacy Studies for Animals • Facility and Investigator Sourcing • Negotiation and Contracts • Literature Search • Study Design, Protocol Development and Forms Design • Study Monitoring • Quality Assurance • Method Validation • Data Auditing and Statistical Analysis • Scientific Reporting • Regulatory Compliance • Site Inspection Guidance is provided for outsourcing to qualified testing facilities or clinical investigators for the study.
3. Regulatory Affairs Guidance provided for: • Requirements of Regulatory Approval • Preparing and Submitting Protocols • Arranging Conduct of the Studies • Preparing and Submitting application for: o New Animal Drug Application (NADA) o Abbreviated New Animal Drug Application (ANADA) o Generally Recognized as Safe (GRAS) o Veterinary Biologics License Origo also offers monitoring of specific studies, data analysis and document compilation. Submissions under regulatory services include: • FDA-CVM- Veterinary drugs • USDA-CVB-Veterinary biologics • Veterinary Nutraceuticals
4. Due Diligence Services Origo helps you in licensing transactions, formation of prospective partnerships/alliances right from identifying the potential partners to structuring the licensing agreement.
5. Veterinary Management Veterinary management helps you to identify potential areas of business opportunity in the veterinary formulation market. Origo can help you to gain maximum growth and profitability by identifying the most suitable areas for your business and improving financial management. Services include: • Market feasibility report includes Demand and supply gap analysis, Identification of competitive market, Need gap analysis, SWOT analysis • Financial feasibility report includes analysis of construction, equipment and other costs • Revenue modelling- To include details and analysis of sources of revenue, values to offer, how to price the value