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Consulting
Aveta provides process, technical, GMP and regulatory guidance to the industries that comply with the FDA & EMEA (Pharmaceuticals, Biotechnology & Medical Devices). We understand the interaction between Operations and Compliance in cGMP, GLP and GTP regulated industries. Our experts provide gap assessment, audit preparation, process improvement, qualification/validation & compliance support for some of the best companies in the business.
Aveta’s consultants assist customers in the design, deployment and monitoring of process improvements using a systematic approach to problem solving that includes an investigational toolkit that leverages Six Sigma, Lean Manufacturing, and other process improvement methodologies. Our consultants have decades of experience in process-based critical thinking & problem solving to facilitate structured change to improve your process inclusive of development, tech transfer, training & ongoing mentoring skills.
Aveta’s approach focuses on a well reasoned and documented rationale coupled with good data collection practices to provide a fully compliant, GMP integrated solution that speaks to the bottom line business of our clients. To keep current, Aveta stays abreast of new practices and regulatory changes by actively participating in trade organizations & conferences such as ISPE, PDA, ASQ, Interphex, Bio, etc.
Aveta’s methodology provides a consistent framework to ensure the success of projects:
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Process Approach to Projects:
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Clear Definition of the Problem |
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Thorough Investigation using the Process Toolkit |
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Determine Root Cause Based on Analysis of Significant Data |
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Develop a Solution with Predefined Metrics to Determine Success |
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Implement the Solution |
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Evaluate the Results through the Predefined Metrics |
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Roll-out Successful Improvements and Monitor Long Term |
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Critial Thinking Methodologies that take into account:
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Product & Process |
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Operations & Environment |
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Quality / Compliance |
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Risk Assessment & Management |
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FMEA / HAACP / PHA / Ishikawa Diagrams |
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New regulations: ICH & Risk Based GMPs |
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Six Sigma / Lean Manufacturing Tools |
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Process Charette for rapid Design / Tech Transfer / BOD Development |
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Sustainable Implementation
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Strong Project Management foundation for project delivery |
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Hands-on assistance until its right |
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Process support to integrate Operations with Compliance |
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Lean approach to SOP development |
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Integrated Training that focuses on Best Practices |
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Sustainable Success |
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Aveta provides consultation services in the following areas:
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