Your probability of success increases the earlier and more thoroughly you prepare – our proven processes fully prepare your organization for any regulatory challenges.
We’re a consulting firm specializing in regulatory compliance, FDA inspection readiness, quality engineering, and validation projects for the medical device, biological, and pharmaceutical industries.
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 [...]
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 [...]
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
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
S3 Method: Simple, Systematic, Sustainable Can You Be Compliant While Keeping Costs Down & Positively Impacting Your Bottom Line? YES… when you follow BioTeknica’s S3 – Simple, Systematic, Sustainable methods! Simple, Systematic, Sustainable Methods for Regulatory Services [...]
Quality Engineering Are you able to resolve the root cause? Quality Engineering services using proven methodologies to resolve life science engineering challenges A review of 483 / Warning Letters indicates that life science manufacturers have recurring problems with design, production and process controls, as well as CAPA, and other [...]
Validation Services BioTeknica provides proven validation methodologies that have been successfully implemented for our clients at both small and large Medical Device and Pharmaceutical manufacturers. Validation Services for Medical Device & Pharmaceutical Manufacturers Do all of your products, equipment, processes, software, and systems operate as designed and intended? Inadequate [...]
Regulatory Services for Medical Device & Pharmaceutical Industries BioTeknica provides expert clinical and regulatory support for all phases of global medical device and drug development. We support clinical and regulatory activities in the USA, European Union, as well as the emerging Asia Pacific, Latin American, Central, and Eastern European markets. Regulatory [...]
S3 FDA Inspection Readiness Services Are You Ready? Have you done everything possible to prepare for your next FDA Inspection? Are you gambling with your next inspection? Do you rely solely on in-house staff to prepare? Obtaining an independent review is critical to ascertain your site’s true [...]
Regulatory Compliance We not only know what to do but – how to do it. We ensure that your quality systems are compliant with both the intent and spirit of FDA regulations. Regulatory Compliance programs for life science manufacturers How do you achieve compliance while managing your business needs? Regulatory agencies demand [...]
