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.
Across the medical device and regulated digital health space, one theme keeps surfacing in regulatory feedback and internal reviews: Design Controls can’t just be a checkbox. They have to reflect a genuine understanding of your users and an intentional design around their needs. Regulators and auditors are looking beyond procedures and templates. They are asking [...]
How Non-Compliance Can Impact Medical Device Manufacturers—and What You Can Do to Prepare Process validation is a critical requirement for medical device manufacturers. The FDA routinely issues Form 483s and Warning Letters when companies fall short in this area, underscoring the importance of robust validation protocols. Since 2020, there have been at least 43 documented [...]
Due Diligence and Quality Systems Integration… More Important than Ever during Tumultuous Period for Pharmaceutical and Medical Device Industry Global Trade Wars … Supply Chain Interruptions … U.S. government initiatives for reshoring of manufacturing for critical Medical Device and Pharmaceutical products … these are all significant drivers for mergers and acquisitions during this period which [...]
IS/ IT Information Systems Management A Division of BioTeknica, an IQVIA Business 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 [...]
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 our 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, an IQVIA business, 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 [...]
