We’re passionate about figuring out how to expertly integrate both the intent and interpretation of regulations to your specific products. So ask yourself how we can assist you.
Regulatory Compliance: How do you achieve compliance while managing your business needs?
Regulatory agencies demand that manufacturers maintain compliance throughout all stages of a product’s lifecycle, from concept to commercialization, including post-market compliance. BioTeknica’s team of experts quickly integrate into your business processes, educating staff on current trends, thereby minimizing or eliminating down time. Starting with a comprehensive gap analysis, enhancing your quality systems, and concluding with effectiveness checks, we achieve compliance while remaining sensitive to your bottom line.
BioTeknica Regulatory Compliance services:
- Compliance Audits and Assessments
- Third-Party Certification
- Quality Systems Development and Remediation
- 483/Warning Letter/Consent Decree Resolution
Inspection Readiness: Are you gambling with your next inspection?
Do you rely solely on in-house staff to prepare? Obtaining an independent review is critical to ascertaining your site’s true readiness. Our regulatory professionals quickly identify your vulnerabilities and prevent or mitigate them from becoming significant compliance issues. Our systematic, proven, risk-based approach and experiential learning goes beyond the traditional “mock audit” to prepare SMEs and staff to competently respond to all investigator queries. Avoid inspection surprises. Prepare early, often and thoroughly.
BioTeknica Inspection Readiness services:
- Strategy development for identified compliance vulnerabilities
- Simulated inspections
- Risk-based preparation
- Inspection oversight and management
- Experiential learning for SMEs
Quality Engineering: Are you resolving the root cause?
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 issues. Superficial patchwork compliance solutions are not the answer. BioTeknica’s skilled quality engineers analyze and identify the root cause, utilizing proven methodologies such as Six Sigma, Kepner-Tregoe, and Taguchi, to effectively resolve engineering challenges. Ultimately, our root cause solutions save you time and resources.
BioTeknica Quality Engineering services:
- Analyze quality issues
- Identify root causes
- Utilize statistical techniques, evaluation and optimization
- Develop and implement solutions
Validation: Do all of your products, equipment, processes, software and systems operate as designed and intended?
Inadequate validation is a common source of FDA 483 findings. Responding to them can be costly and disruptive, especially if it requires the validation of your legacy products, test methods, equipment, and processes. If just one validation segment doesn’t meet regulatory standards, it can negatively impact your organization. We enhance your future bottom line by characterizing, optimizing, and thoroughly validating your production processes and systems.
BioTeknica Validation services include:
- Validation master plans, procedures and protocols
- Equipment, facilities/utilities commissioning/qualification
- PLC/control systems and software validation
- Test method and process validation