RoseTECH Consulting, Inc.

Professionals Who Understand the Science Behind the Quality Assurance

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Text Box: RoseTECH Services Include: GLP & Technical Training FDA, EPA, & OECD GLPs Basic GLP New Hire Orientation Training Annual GLP Refresher Training Study Director Training Good Documentation Practices Study Reconstructibility Current BioAnalytical Guidance Update Special Topic Training Onsite Customized Training Session, Workshops, Webinars Quality Assurance Auditing and Inspections Heavy Workload, Tight Deadlines, Staffing Shortages RoseTECH provides services to help enable our clients meet their needs during heavy workloads, tight deadlines, or staffing shortages, serving as an extension of the client's Quality Assurance Unit. Sponsor Representative RoseTECH can also serve as a Sponsor representative and conduct QA audit of ongoing or completed studies for Sponsor review and evaluation. Independent Third-Party Expert RoseTECH has experience conducting third-party independent audits and inspections, to evaluate study integrity and reconstructibility and report findings in response to mandated regulatory agency requests to Sponsors. Study Auditing Protocol Review In-Study Inspections Data & Report Audits Third-Party Independent Audits Facility Inspections Subcontractor Audits Vendor Qualification Audits Domestic and International CRO Audits Third-party Independent Audits Start-up Facility Inspections/GLP GAP Inspection GLP Consulting Standard Operating Procedure (SOP) Writing & Review RoseTECH consultants have vast experience in the writing and review of SOPs, from general high-level SOPs to specific operations. GLP Start-Up - Transition from R&D to GLP RoseTECH specializes in conducting GLP facility audits to identify gaps between current status and GLP requirements.  An extensive report is presented to the client summarizing findings and recommendations.  We then work with the client to develop a detailed plan for GLP Quality System implementation customized to meet the facility's needs & timeframes. GLP Quality System/Implementation RoseTECH works with the client to execute the implementation plan, including development of Standard Operating Procedures (SOPs) and quality systems (e.g. archives, master schedule, training documentation).  We provide training to staff to establish GLP roles & responsibility, and identify compliance and regulatory requirements applicable to their intended involvement in the area of GLP. QA Management RoseTECH provides services for interim QA management.  This may be needed when a new Quality System is being implemented or when the client has an interruption in QA management staffing. Technical Consulting RoseTECH consultants have scientific expertise,  experience in the conduct and supervision of GLP studies, and knowledge in the GLP regulations and guidances. Analytical/Bioanalytical Method Validation Dose Prep Dose Analysis Dose Administration Test Material Characterization Toxicology & Metabolism PK/TK GLP Study Conduct Technical Writing  Standard Operating Procedures GLP Protocol/Report Templates Report Writing/Review Analytical Test Methods Documentation/Record-Keeping For more about our services email: services@rosetechconsulting.com

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