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triligent

Auditing: US and Worldwide. Project and Site Management. Expert analysis of the science, quality, IP, content and regulatory integrity of trials. 8211; Select Service —. Auditing: US and Worldwide. A worry-free pathway to market approval for pharma, biotech, and medical device companies. 8211; Select Service —. Regulatory strategies that get a product to market quickly and in a cost effective manner. Solutions to pivotal issues within the design and implementation of complex development plans.

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triligent | triligent.com Reviews
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Auditing: US and Worldwide. Project and Site Management. Expert analysis of the science, quality, IP, content and regulatory integrity of trials. 8211; Select Service —. Auditing: US and Worldwide. A worry-free pathway to market approval for pharma, biotech, and medical device companies. 8211; Select Service —. Regulatory strategies that get a product to market quickly and in a cost effective manner. Solutions to pivotal issues within the design and implementation of complex development plans.
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KEYWORDS
1 resources
2 quality
3 assurance
4 quality system development
5 sop development
6 clinical research
7 services
8 clinical development/operations
9 monitoring
10 gap analysis
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resources,quality,assurance,quality system development,sop development,clinical research,services,clinical development/operations,monitoring,gap analysis,training gxp,regulatory,consulting,vc support,expertise,investment due diligence,quality assurance
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triligent | triligent.com Reviews

https://triligent.com

Auditing: US and Worldwide. Project and Site Management. Expert analysis of the science, quality, IP, content and regulatory integrity of trials. 8211; Select Service —. Auditing: US and Worldwide. A worry-free pathway to market approval for pharma, biotech, and medical device companies. 8211; Select Service —. Regulatory strategies that get a product to market quickly and in a cost effective manner. Solutions to pivotal issues within the design and implementation of complex development plans.

INTERNAL PAGES

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1

Resources « triligent

http://triligent.com/resources

Auditing: US and Worldwide. Project and Site Management. International Conference on Harmonization (ICH). ICH Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance. ICH E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions. ICH E2A: Clinical Safety Data Management: Definitions and Standards of Expedited Reporting. ICH E2C: Periodic Risk-Benefit Evaluation Report. ICH E2E: Pharmacovigilance Planning.

2

Auditing: US and Worldwide « triligent

http://triligent.com/quality-assurance/auditing-us-and-worldwide

Auditing: US and Worldwide. Project and Site Management. Auditing: US and Worldwide. Clinical Labs / Core Labs. 21 CFR Part 11. Packaging & Labeling. Triligent has always done very professional work, even under the most difficult of circumstances. Their knowledge in GCP and auditing is un-surpassed. Jan Lessem, M.D., Ph.D., President, Clinstrat. Auditing: US and Worldwide. You can trust our team to give you the peace of mind you crave. You have questions that our experience can help solve. We conduct aud...

3

Site Map « triligent

http://triligent.com/site-map

Auditing: US and Worldwide. Project and Site Management. Triligent has always done very professional work, even under the most difficult of circumstances. Their knowledge in GCP and auditing is un-surpassed. Jan Lessem, M.D., Ph.D., President, Clinstrat. Case Study Midsize Pharma. Case Study Small Pharma. Case Study International Pharma. Case Study Investment Group. Case Study Mid-Sized Biotech Company. Source Documents and Case Report Forms. Project and Site Management. Auditing: US and Worldwide.

4

SOP Development « triligent

http://triligent.com/quality-assurance/sop-development

Auditing: US and Worldwide. Project and Site Management. Auditing: US and Worldwide. Clinical Labs / Core Labs. 21 CFR Part 11. Packaging & Labeling. Triligent has always done very professional work, even under the most difficult of circumstances. Their knowledge in GCP and auditing is un-surpassed. Jan Lessem, M.D., Ph.D., President, Clinstrat. Detailed SOP Evaluation and Development. Evaluation of Client Needs. Review and Editing of Existing Processes and SOPs. Development of New SOPs.

5

Investment due diligence « triligent

http://triligent.com/vc-supportservices/investment-due-diligence

Auditing: US and Worldwide. Project and Site Management. Investment Due Diligence to Ensure a Sound Investment. Our expert legal partners (most ex-FDA attorneys) provide a suite of services including an in-depth analysis of IP portfolios; regulatory or regulatory-legal issues; governmental relations; FDA liaison services; and, if required, litigation professionals.

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Auditing: US and Worldwide. Project and Site Management. Expert analysis of the science, quality, IP, content and regulatory integrity of trials. 8211; Select Service —. Auditing: US and Worldwide. A worry-free pathway to market approval for pharma, biotech, and medical device companies. 8211; Select Service —. Regulatory strategies that get a product to market quickly and in a cost effective manner. Solutions to pivotal issues within the design and implementation of complex development plans.

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Auditing: US and Worldwide. Project and Site Management. Expert analysis of the science, quality, IP, content and regulatory integrity of trials. 8211; Select Service —. Auditing: US and Worldwide. A worry-free pathway to market approval for pharma, biotech, and medical device companies. 8211; Select Service —. Regulatory strategies that get a product to market quickly and in a cost effective manner. Solutions to pivotal issues within the design and implementation of complex development plans.

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