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GxP, 21CFR Part 11 (ERES), training, audits, safety, QC/QA, validations

 

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Costs do not take into account other factors such as (these will be added to quote):

  • Remote or on-site

  • Geographic Location

  • Various Factors

  • Deadlines

  • Team Size

  • Support

  • Equipment rental / use and supplies

  • Travel & Expense

  • Western European, Asiatic-Australian countries are up to %30 less.

  • Eastern / Central European countries are up to %60 less

  • Note: Prices may change at any time without notice

Validations (Retrospective / Concurrent / Prospective)

Hourly Rate $

Process get a quote
Equipment get a quote
     Boxing / Packaging$35 - 45
     Filling / Cream / Solutions$40 - 55
     Tableting / Press / Solid dose / Creams$30 - 50
     Filter Integrity tester$45 - 60
     Isolator$30 - 50
     Kaye Validator$30 - 40
     Various other....get a quote
Facility get a quote
Cleaning get a quote
Test Method (TMV)get a quote
Computerized systems (Part 11)get a quote
Client / Server / Network $30 - 50
PLCget a quote
     Siemens$30 - 60
     Klöckner-Möller $30 - 60
     Rockwell$30 - 60
     GE Fanuc$30 - 60
     various other....get a quote
PCS / SCADA get a quote
     Wonderwear$20 - 40
     Emerson - DeltaV$20 - 50
     OSI/PI$20 - 50
     RSMACC$20 - 50
     WinCC$20 - 50
     Intellution – iFIX / FIX32 / FixDmacs $20 - 40
     iHistorian$20 - 40
     FinnAqua$20 - 40
Automated System get a quote
Software OTS or Customizedget a quote
ERP / MRPget a quote
      SAP / JD-Edwards$30 - 45
      MfgPro$30 - 45
CAPA systems get a quote
Laboratory get a quote
     HPLC$30 - 60
     FPLC$30 - 60
     FTIR$30 - 60
     TOC$30 - 60
     GC$30 - 60
     Spectrophotometers$30 - 60
     Centrifuge$30 - 60
     Various other instruments...get a quote
Calibration Management System get a quote
     Blue Mountain Calibration Systemget a quote
V&V $40-65
Documentation Management Systems get a quote
     Documentum$30 - 60
    MetaPhase$30 - 60

Quality Assurance / Engineering

 
Design of Experiment Studies (DOE) $30 - 60
Change Control $30 - 60
Document Control$30 - 60
Process Capabilities (Cpk) $30 - 60
Batch Verifications $30 - 60
Stability / Kinetics$45 - 80
PMA / 510K submission help$30 - 60
INDA / NDA submission help$30 - 60
Develop Test Methods / SOP's$30 - 60
Corrective Action / Preventive Action (CAPA)$30 - 45
Pre-approval Inspection (PAI) Preparation $30 - 60
Resolve 483's / write-ups, and CD's$30 - 60
RMA's$30 - 40

Training

 
GMP get a quote
QSR get a quote
GLP get a quote
Part 11 get a quote
Validations get a quote
Auditsget a quote

Audits

 
Documentation $28 - 40
Vendor / Supplier $30 - 40
Validation $40 - 55
Facilities $30 - 40
cGLP / cGMP / QSR $30 - 40
Process $40 - 55
Warehouse $28 - 40
Part 11 - Gap analysis $40 - 60
DEA Auditing$30 - 40

Safety

 
Cal-OSHA $28 - 45
Fed-OSHA $28 - 45
Proposition 65 $28 - 45
EPA$28 - 45

Development & Product Transfer

 
Characterize processes / formulationsget a quote
Develop methods, equipment and systemsget a quote
Simplify processes (downstream / upstream)get a quote
Product Transfer R&D to Manufacturingget a quote
Product / Process Xfer - Facilityget a quote
Reduce Failure rateget a quote
Business Strategy Evaluationget a quote
Factory Acceptance Testing / Site Acceptance Testing (FAT / SAT)get a quote

Environmental Monitoring

 
PM count$20 - 30
RODAC™ sampling$20 - 30
Surface Swabbing$20 - 30
RCS Sampling$20 - 30
Water PM / Bioburden$20 - 30
Product Bioburden$20 - 30

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