About Kristin Gordon
I provide Quality and Regulatory services for regulated companies. I've built quality systems for companies that are regulated by the USDA, EPA, FDA and foreign regulators. I also do strategy for market access, compliance, quality system, regulatory intelligence, change management, claims with evidence substantiation, product development, pre‑submission, submission, global expansion and lifecycle, risk‑based commercialization, compliance operations, and governance. I've worked with large corporations and with startups in Maine.
- Operational Processes
- Project Management Systems
- Operations and Organizational Systems
- Supplier Sourcing
- Quality Systems
- Physical Product Design & Manufacturing
- Audit Preparation
- Prototyping
- Product Engineering
- Materials and Composites
- Process Improvement
- Regulatory Preparation
- Organizational Structure
The consultants listed in this directory have met MTI's eligibility criteria for the MERC program. MTI does not endorse, recommend, or guarantee the performance of any consultant. Selecting a consultant is the company's decision. Performance scores shown are provided by past MERC grantees, not by MTI.