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RoseTECH Consulting, Inc.

Professionals Who Understand the Science Behind the Quality Assurance

Client Projects

RoseTECH clients include pharmaceutical, biotech, medical device, contract research organizations (CRO), agricultural, and specialty chemical companies.

Examples of past and current projects include:

· Presentation of classroom-type training on topics related to GLP, GMP for labs, and various related topics.  Training has been presented to class sizes from 1 – 100 persons, as customized “in-house” training, or during professional organizational conference training.

· Design and presentation of customized GLP training for Pharmaceutical Training Institute (PTi).

· Serve in role of Interim Quality Assurance Director for CROs.

· Develop and implement GLP Quality Systems to support clients shifting from drug discovery into drug development.

· Develop templates for training records/documentation, SOPs, GLP protocols, study data forms and reports.

· Conduct QA inspection audits and review of data and reports for acute and chronic pre-clinical toxicology, toxicokinetic, pharmacokinetic, bioanalytical, dose formulation analysis, residue analysis, analytical, and method validation studies.

· Conduct GLP subcontractor audits, third-party audits, and study-specific audits.

· Conduct GLP facility audits of analytical, bioanalytical  and animal facilities of pharmaceutical, biotech and CRO companies.

· Conduct in-study laboratory inspections of critical phases pertaining to dose analysis, analytical  bioanalytical, and immunochemical method validations, sample analyses, and sample-generating animal surgeries.

· Conduct QA inspection audits and review data and reports for dose formulation analysis, analytical, bioanalytical and immunochemical method validation, analytical, bioanalytical and immunochemical sample analysis, PK/TK, ADME and in vitro studies.

· Conduct GAP analyses to identify the QA requirements needed for GLP compliance.

· Participate in development and implementation of GLP quality systems to support clients shifting from drug discovery into drug development.

· Generation of toxicology report tables for preclinical toxicology studies (retrieval of data from Instem/Datatox system).

· Conducted GLP study data review and wrote technical/scientific reports and method validation summary reports for FDA submission (served in technical role only and not in QA role).

· Perform gap analysis audit of a global specialty chemical Analytical Research Services Dept. and set up an operational quality system (processes, procedures, SOPs, qualification/validation, training, etc.) to meet compliance standards for GMP QC testing.

· Design, development, implementation, validation and training of web (intranet)-based Product Specification and Certificate of Analysis database, Document Control database and Corrective Actions database for a biopharmaceutical raw material manufacturer.

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