|
|
 |
 |
|
 |
 |
Prelabs' unique combination of technology, facilities, and experience provides our clients with the right tools to support the product development cycle of pharmaceutical entities, including protocol development and GLP-compliant preclinical and non-clinical safety studies. We also provide medical device and biomaterial testing, as well as hands-on application training for company staff and medical investigators, using state-of-the-art ORs, support areas for preparation, surgery scrub and instrument preparation, necropsy and pathology support. Our AAALAC-accredited vivaria facilitate access to both small and large animal models including NHPs. |
|
|
 |
| Mice |
Ferrets |
| Rats |
Felines |
| Guinea Pigs |
Canines |
| Hamsters |
Swine |
| Rabbits |
Non-human primates |
|
 |
 |
 |
|
 |
| Oral |
Intravenous |
| Dermal |
Intramuscular |
| Feeding |
Oral Mucosal |
| Nasal |
Subcutaneous |
| Ocular |
Rectal |
| Vaginal |
Inhalation |
|
 |
|
|
 |
|
|
|
|
 |
|
 |
 |
Task |
PreLabs |
Client |
Initial client interaction |
√ |
√ |
Optional discussions of confidentiality disclosure agreement |
√ |
√ |
Identify client requirements |
√ |
√ |
Identify in-house capabilities and outsourcing collaborations required for your study |
√ |
|
Provide initial proposal for study |
√ |
|
Optional site visit and/or, facility audit |
√ |
√ |
Refine study and develop protocol to meet regulatory requirements and animal welfare concerns |
√ |
|
Establish start date and desired completion date |
√ |
√ |
Coordinate all aspects of the outsourcing, required approvals (animal care committee) and establish timelines for study |
√ |
|
Review study requirements with Study Director, Study Team and Operations Manager |
√ |
|
Test article sent by client and received at study site |
|
√ |
Perform study with monitoring of study progress and providing oversight to outsourced study components |
√ |
|
Quality Assurance oversees study and inspects critical phases |
√ |
|
Generation of draft Report for feedback by client |
√ |
|
QA reviews study documents and report |
√ |
|
Client reviews draft Report |
|
√ |
Respond to client feedback on report and QA |
√ |
|
Finalize report |
√ |
|
Client accepts final report |
|
√ |
|
 |
 |
|
|
|
|
 |
|
|
|