Trinh Tran-Maynard's Contact Details

Trinh Tran-Maynard's Company Details

Pro-Ones, LLC. is a life science consultancy that successfully takes projects to completion and provides staff augmentation in the following disciplines: * Project Program Management, NPI program, NPO initiation, CMC program, manage from small to complex facility startup, operations readiness,...* Commissioning and Validation: MS Excel Spreadsheet Validation, Computerized System Validation, Network Qualification, Software Validation, Cleaning Validation, Process Validation, Shipping Validation, Cold Chain Qualification, Cold Chain Package Qualification, Analytical Method Validation, Equipment Qualification, Utilities Qualification, Facility Qualification, Commissioning, ASTM E2500, Remediation, Gap Assessment.* Compliance: GLP Audits, GCP Audits, GMP Audits, Gap Assessments, Remediation, 483 Responses, Warning Letter Responses, Consent Decree Support.* Quality Assurance: Risk Assessments, QA Oversight, QA Review & Approval, Quality Management Systems.* Regulatory Affairs: IND, NDA, BLA, ANDA, Preapproval Inspections (PAI), IDE, 510K, PMA and FDA Registered Agent Services.* Technical Transfer Services: Technical Transfer, Scale-up, Cleaning Validation, Process Validation, Analytical Method Validation, Process Development, Cold Chain Qualification.* Training: GLP, GCP and GMPPro-Ones deploys teams of driven professionals or specialized technical consultants who can help deliver your project or improve existing operations. Pro-Ones strives to provide exceptional consulting services where our team of people can realize their gifts, apply and develop their talents, and feel a genuine sense of fulfillment for their contributions in pursuit of a common inspirational vision.We look forward to understanding your needs for Engineering, Technical Services, Validation, Compliance, Regulatory Submissions, Project Management, and Quality Assurance.