BLOG2021-02-12T04:29:57+00:00

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 Government Investigations Major Product's Liability Litigation Integrity Inquiries Import Alerts/Bans Seizure Injunctions Administrative Detention Civil Actions Criminal Actions Corporate or Multi-Facility Warning Letters Monitoring of North American & European Union Regulatory Activities What is Critical Issue Management? Bioteknica can help resolve issues arising from FDA management mishaps including warnings, [...]

By |February 2nd, 2021|Tags: , , |

Operational Review

By |February 2nd, 2021|Categories: Services|

Operational Review & Optimization for Medical Device and Pharmaceutical Companies   Cost Reduction Strategies Business Process Re-engineering (BPR) Process Optimization/Improvement Process Control [...]

  • regulatory services

Regulatory Services

January 29th, 2021|0 Comments

Regulatory Services for Medical Device & Pharmaceutical Industries BioTeknica provides expert clinical and regulatory support for [...]

Lean Quality Solutions

January 26th, 2021|0 Comments

Lean Quality Solutions for Medical Device & Pharmaceutical Companies Synergis, a sister company of BioTeknica, offers comprehensive lean [...]

202, 2021

Operational Review

February 2nd, 2021|0 Comments

Operational Review & Optimization for Medical Device and Pharmaceutical Companies   Cost Reduction Strategies Business Process Re-engineering (BPR) [...]

ASK A BIOTEKNICA SME HOW TO VALIDATE A PROCESS WITH A “HIGH DEGREE OF ASSURANCE” AND WHAT DOES THAT EVEN MEAN?

By |May 18th, 2020|Categories: Blog, S3 Compliance Matters|

Looking for answers to your regulatory questions? To submit one, please click on Ask a BioTeknica SME and our Subject Matter Experts (SMEs) will share their [...]

KEY FDA EXPECTATIONS FOR ADVERSE EVENT REPORTING DURING A PANDEMIC

By |May 18th, 2020|Categories: Blog, S3 Compliance Matters|

The FDA has modified the regulations regarding adverse event reporting during a pandemic to include COVID-19. Click below for key points about the updated [...]

BIOTEKNICA OPERATING AT FULL CAPACITY Company Implements Business Continuity Plan During COVID-19 Crisis

By |May 18th, 2020|Categories: News, Press Releases|

BioTeknica and its sister companies, Qualified Data Systems and Synergis, are here for you. We are open and operating at full capacity with the [...]

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