IS/IT Information Systems Management

IS/ IT Information Systems Management A Division of BioTeknica About Our Information Systems Management Services Access to the right data at the right time is the key to making Quality and Compliance business decisions. QDS brings together a comprehensive portfolio of Business Intelligence and Data Management [...]

By |2021-03-03T14:32:41+00:00February 2nd, 2021|Services|0 Comments

Critical Issue Management

Critical Issue Management for FDA 483 Warning Letters, Recalls & Safety Alerts Agency Representation & Negotiation Recalls, Field Corrections & Safety Alerts 483/Warning Letter/Consent Decree Resolution Compliance Certification Import Alert & Detention Removal Programs Consent Decree Programs HIPAA Subpoenas [...]

By |2021-03-03T14:32:24+00:00February 2nd, 2021|Services|0 Comments

Technical Development Service

Medical Device Design Control, Product Development & Quality Testing Product Development Management Design Control Process/Design and Implementation Regulatory Compliance Regulatory, Quality & Clinical Trial Planning Product Development and Design Control Process and Test Method Development Training & Education Risk Analysis Due Diligence Evaluations

By |2021-03-03T14:30:51+00:00February 2nd, 2021|Services|0 Comments

Operational Review

Operational Review & Optimization for Medical Device and Pharmaceutical Companies   Cost Reduction Strategies Business Process Re-engineering (BPR) Process Optimization/Improvement Process Control and Automation Product Equipment Relocation Reliability, Manufacturing & Maintainability Due Diligence Evaluations

By |2021-03-03T23:27:50+00:00February 2nd, 2021|Services|0 Comments
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