Andesys

Validation. Compliance. Remediation. Mitigation.

About Andesys

We implement cost efficient long term solutions from analysis to strategy in collaboration with all appropriate stake holders to detail the objectives with the highest level of experienced consultants.

Analysis

Resolve system into subset elements

Design

Formulate intended use plan

System

Group elements to function as a whole

Synthesis

Integrate coherently analyzed elements

Our Mission

Andesys creates solutions in the areas of validation, compliance, remediation, and mitigation for pharmaceutical FDA regulation and banking SEC regulaton

Our Vision

Banking and pharmaceutical companies need industry experts, using the newest technology, to comply with FDA, and SEC regulations.

SERVICES

What we offer

FDA

FDA related services

DD

Due Diligence Audit Procedures

QA

Quality Assurance And Controls

Validation

System And Process Validation

Evaluation

System Evaluation

CSV

Computer System Validation

Services We Provide

We supply the finest consultants in the areas of regulatory compliance, submission and approval of drugs, medical devices and software development for on site or remote work. We also developed software applications for our clients in the areas of FDA and SEC regulation.

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Portfolio

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Halfmann Goetsch Prn

Project Quality Mgmt, Product Lifecycle Management.

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norvaris

Project Quality Manager, SOX Business Compliance Controls

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credit suisse

Production & Testing

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IBM

Business Compliance Controls. Global Audit.

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validation plus

FDA and EMEA compliance & validation.

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Smith & Nephew Ortho

Compliance Remediation

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wuxi apptec

Computer Systems Validation

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allergan

Regulatory Compliance Remediation.

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Monsanto Company

Computer Systems Validation.

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pfizer

Computer Systems Validation

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cordis

Computer Systems Validation. Regulatory Compliance Remediation Auditor

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amgen

Regulatory Compliance Mitigation

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American Red Cross

Regulatory Compliance Remediation Coordinator

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RBC Dominion Sec

Compliance Auditor

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JAN Kelley Marketing

IT Project Remediation

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gap

SOX Compliance Auditor

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hughes aircraft

IT QA

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ncr corporation

project management

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lavalife

IT QA

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the bank of montreal

IT-QA compliance

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gsk

project management

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unisys

project management

What our customers say

Contact Andesys

Contact Andesys International to learn more about what we can do for you.

contact@andesys.com

Careers

If you are a regulatory, compliance or technical professional and would like to be considered for a consulting position, please contact us!

careers@andesys.com