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Validation Edge - Home

Validation Edge provides support & consultation for Facility, Utilities and Equipment Qualification, Process, Cleaning & Computer System Validation

http://www.validationedge.com/

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Validation Edge - Home | validationedge.com Reviews
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Validation Edge provides support & consultation for Facility, Utilities and Equipment Qualification, Process, Cleaning & Computer System Validation
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1 Validation Edge
2 Utilities Equipment Qualification
3 Process Scale-up
4 Process Validation
5 Cleaning Validation
6 Computer System Validation
7 Pharmaceutical
8 Biotechnology
9 Medical Device
10 Diagnostic
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mission and values,expertise,services,vmp's and sop's,process validation,cleaning validation,computer system validation,analytical method validation,training,resources,articles,search the site,careers/collaborations,process scale up,proud member of
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Validation Edge - Home | validationedge.com Reviews

https://validationedge.com

Validation Edge provides support & consultation for Facility, Utilities and Equipment Qualification, Process, Cleaning & Computer System Validation

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1

Validation Edge - New Page

http://www.validationedge.com/company/mission-values.html

Compliance and Cost Competitiveness. Commissioning and Qualification (IQ, OQ, PQ). Compliance and Quality Assurance. R&D, Technology Transfer and Scale-up. Our mission is to provide leading edge validation services to our clients in Life Science industry while ensuring regulatory compliance and cost competitiveness. Professional Ethics, Intergrity, Reliability, Team Work, Holistic Approach, Data-driven Solutions, Sustainable Improvements, Long-term Parterships, and Respect. Validation Edge, LLC.

2

Validation Edge - Compliance and Quality Assurance

http://www.validationedge.com/services/compliance-quality-assurance.html

Compliance and Cost Competitiveness. Commissioning and Qualification (IQ, OQ, PQ). Compliance and Quality Assurance. R&D, Technology Transfer and Scale-up. Compliance and Quality Assurance. ValidationEdge specializes in developing compliant, quality. Systems that are easy to monitor and control. We strongly believe Quality systems should work for our clients and not the other way around. The importance of regulatory compliance and Quality assurance in FDA regulated industry is paramount.

3

Validation Edge - Resources

http://www.validationedge.com/resources.html

Compliance and Cost Competitiveness. Commissioning and Qualification (IQ, OQ, PQ). Compliance and Quality Assurance. R&D, Technology Transfer and Scale-up. Click here to see a list of articles from our team. Click here to search our site. Over 30 years of experience in the pharmaceutical. PTS Consulting Global Services has been actively involved in Pharmaceutical consulting, including product development and support activities including but not limited to, preclinical, clinical, bioequivalence studies, c...

4

Validation Edge - VMPs and SOPs

http://www.validationedge.com/services/vmp-sop.html

Compliance and Cost Competitiveness. Commissioning and Qualification (IQ, OQ, PQ). Compliance and Quality Assurance. R&D, Technology Transfer and Scale-up. Validation Master Plans (VMP's) and Standard Operating Procedures (SOP's). Developing Validation Master Plans (VMP's). Standard Operating Procedures (SOP's). To assist in building the foundation of technically sound and compliant validation programs. Process Validation Master Plan. Cleaning Validation Master Plan. Computer System Validation Master Plan.

5

Validation Edge - Validation Edge Expertise

http://www.validationedge.com/company/expertise.html

Compliance and Cost Competitiveness. Commissioning and Qualification (IQ, OQ, PQ). Compliance and Quality Assurance. R&D, Technology Transfer and Scale-up. Our expertise in Pharmaceutical. Biotechnology, Medical Device, Diagnostic and Active Pharmaceutical Ingredient (API) industries is supported by decades of professional experience of SME's having exceptionally high academic credentials in the field of Pharmaceutics, Engineering, Microbiology and Chemistry. Validation Edge, LLC. Lenexa, Kansas USA.

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LINKS TO THIS WEBSITE

ptsglobalservices.com ptsglobalservices.com

PTS Pharmaceutical Consulting Services - Partnerships

http://www.ptsglobalservices.com/partnerships.html

Serving the pharmaceutical and related industries. INDs (Investigational New Drug) and ANDs (Abbreviated New Drugs). Filing and Managing all of the Processes for FDA Drug Applications. FDA and Global Regulatory Compliance and Submission. Complete Facilities Design from inception to full FDA qualification. One of our Partner Companies, Piramal (PCR),. Succssfully passed a USFDA Audit with glowing endorsement. Two audits were recently conducted by the USFDA for both clinical and bioanalytical services.

ptsglobalservices.com ptsglobalservices.com

Our Partnerships

http://www.ptsglobalservices.com/partnerships

Serving the pharmaceutical and related industries. INDs (Investigational New Drug) and ANDs (Abbreviated New Drugs). Filing and Managing all of the Processes for FDA Drug Applications. FDA and Global Regulatory Compliance and Submission. Complete Facilities Design from inception to full FDA qualification. One of our Partner Companies, Piramal (PCR),. Succssfully passed a USFDA Audit with glowing endorsement. Two audits were recently conducted by the USFDA for both clinical and bioanalytical services.

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Validation Edge - Home

Compliance and Cost Competitiveness. Commissioning and Qualification (IQ, OQ, PQ). Compliance and Quality Assurance. R&D, Technology Transfer and Scale-up. Validation Edge, LLC. Has a proven track record of creating policies, procedures and templates for the commissioning, qualification and validation protocols and final reports. We provide support and consultation for the Facility, Utilities and Equipment Qualification. And Continuous Improvement projects for the Pharmaceutical. Validation Edge, LLC.

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