Walker Downey & Associates
Consulting firm providing toxicology, biocompatibility, preclinical study design and monitoring, statistical analysis, regulatory affairs, and quality assurance services for medical device, biotechnology, and pharmaceutical clients. Services include risk assessments, expert opinions, proof-of-concept large-animal testing (porcine), CRO selection and oversight, GLP auditing, and regulatory submission support.
Industries
Nr. of Employees
small (1-50)
Walker Downey & Associates
Verona, Wisconsin, United States, North America
Products
Medical Device Biocompatibility Evaluation Consulting
Provides guidance on biocompatibility testing and justifications for testing exemptions using evidence-based risk assessments and expert opinions.
Preclinical Development Program Assessment and Planning
Offers assessment and planning services for preclinical study programs to support medical device development.
Risk Assessment and Expert Opinion Services
Delivers evidence-based risk assessments and expert opinions to support product safety and regulatory decisions.
FDA Meeting Support and Regulatory Affairs/Quality Assurance Services
Supports clients with FDA meeting preparation, responses, and regulatory affairs and quality assurance consulting.
Statistical Design and Review Services
Provides statistical design, review, and analysis support for medical device studies and data.
Medical Device Biocompatibility Evaluation Consulting
Provides guidance on biocompatibility testing and justifications for testing exemptions using evidence-based risk assessments and expert opinions.
Preclinical Development Program Assessment and Planning
Offers assessment and planning services for preclinical study programs to support medical device development.
Risk Assessment and Expert Opinion Services
Delivers evidence-based risk assessments and expert opinions to support product safety and regulatory decisions.
FDA Meeting Support and Regulatory Affairs/Quality Assurance Services
Supports clients with FDA meeting preparation, responses, and regulatory affairs and quality assurance consulting.
Statistical Design and Review Services
Provides statistical design, review, and analysis support for medical device studies and data.
Services
Toxicology Consulting
Consulting on toxicology study strategies, protocol development, literature review, and interpretation of toxicology data for regulatory submissions.
Statistical Consulting
Statistical design, analysis, expert opinions, pharmacokinetic modeling, and preparation of statistical reports for study and regulatory use.
Proof-of-Concept Large-Animal Testing
POC testing in domestic pigs using a USDA-standard environmentally controlled isolation facility, including veterinary oversight and round-the-clock animal care.
Regulatory Affairs Services
Preparation of expert opinions, risk assessments, regulatory documentation, and representation at pre-submission meetings with regulatory agencies.
Quality Assurance and GLP Auditing
Quality system assessments, GLP auditing of studies and statistical packages, and support for compliance with QA/GMP/GLP requirements.
Strategic Sourcing and CRO Management
Identification and qualification of CROs, broadcasting RFPs, auditing capabilities, negotiating study placement and costs, and providing study monitoring services.
Toxicology Consulting
Consulting on toxicology study strategies, protocol development, literature review, and interpretation of toxicology data for regulatory submissions.
Statistical Consulting
Statistical design, analysis, expert opinions, pharmacokinetic modeling, and preparation of statistical reports for study and regulatory use.
Proof-of-Concept Large-Animal Testing
POC testing in domestic pigs using a USDA-standard environmentally controlled isolation facility, including veterinary oversight and round-the-clock animal care.
Regulatory Affairs Services
Preparation of expert opinions, risk assessments, regulatory documentation, and representation at pre-submission meetings with regulatory agencies.
Quality Assurance and GLP Auditing
Quality system assessments, GLP auditing of studies and statistical packages, and support for compliance with QA/GMP/GLP requirements.
Strategic Sourcing and CRO Management
Identification and qualification of CROs, broadcasting RFPs, auditing capabilities, negotiating study placement and costs, and providing study monitoring services.
Expertise Areas
- Medical device biocompatibility
- Toxicology and nonclinical safety assessment
- Preclinical large-animal (porcine) studies
- Regulatory affairs and FDA interactions
Key Technologies
- Large-animal models (porcine)
- GLP-compliant study design
- Biocompatibility testing (ISO 10993 framework)
- Pharmacokinetic modeling