Regulatory Services
Some of us are older......we know the path to approval!
Regulatory Services
RTI can assist with product development plans, develop timelines, preparation of regulatory submissions, including protocols, reports and production outlines. RTI will work with regulatory agencies to make sure your product moves through the licensing process in a timely manner.
For inquiries, please contact Carol at RTI at info@4rtilab.com
RTI will work with clients to develop detailed and realistic licensing/development plans.
Advantages of developing the plan:
- The plan is a map that outlines required steps toward licensure.
- Examples:
- Master seed production and testing
- Clinical studies required
- Product potency tests
- Manufacturing processes and scale up
- Validation of processes and tests, etc
- Examples:
- This is a living document that can be used throughout the licensing process to track progress
- Each plan is uniquely designed based on the product specifications.
- Product Licensing Plans, once assembled, can be used to estimate the impact of a delay in the project timeline.
- Recommend review and discussion with the Center for Veterinary Biologics (CVB), comparison to their Licensing Plan for the product
- Can be used to identify the components that impact the Critical Path to licensure
Disadvantages:
- Requires time and resources at the beginning of the project, as well as updates to the document as the project continues. However, time and resource savings are realized by recognition of and focus on Critical Path elements.
A variety of submissions to CVB will be required throughout the life of the project.
- RTI staff has extensive experience in writing and reviewing all types of documents, including study protocols, study reports, test development and validation protocols, validation reports, summary information format documents, production and special outlines, etc.
- These documents can be completed by RTI and either submitted to the sponsor firm or directly to CVB.
RTI staff has had extensive experience in study design and protocol development. This includes:
- Working with statisticians to assure sufficient numbers are included that will result in an experimental design that gives optimum probability of providing valid proof of safety or efficacy.
- Experience with identification of primary efficacy or safety paramenters based on a large variety of disease models. This is something that is required by the Center for Veterinary Biologics (CVB).
- Both efficacy and safety protocols can be designed that will meet USDA as well as European requirements.
- Efficacy studies can be designed and performed to meet Good Clinical Practices (GCP).
- Safety studies can be designed and performed to meet Good Laboratory Practices (GLP).
RTI can provide study reports that are "submission ready" to be sent to CVB as well as European regulatory authorities.
- This would include data preparation and summary ready for submission.
- Data analytics can be completed by one of the consulting staticians available for subcontract through RTI.
In addition, RTI provides services for manuscript preparation for submission to scientific journals.
- Manuscripts can be prepared based on studies performed by RTI.
- RTI will also "Ghost Write" manuscripts for publication on studies performed by the Sponsor without involvement of RTI in the study.
RTI staff has extensive expertise in communications between firms and the regulatory agency. Communications involve written (electronic and hard copy), conference calls and face to face meetings. RTI retains a good reputation as well as a good support rapport with the CVB staff.
- RTI can accompany the sponsor firm at a face to face meeting with CVB to provide technical/regulatory support.
- RTI can act as a primary or secondary liaison with CVB, essentially handling the majority of communications as a representative of the sponsor firm.
- RTI can write and/or review communications prior to being submitted by the firm to CVB.