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

Service Details