Timely & Effective Consulting
FDA Regulated and Fermentation Industries
Simple Compliance Solutions, LLC
We bring hands-on experience and regulatory savvy to organizations trying to navigate the regulatory jungle without wasting valuable time and money or internal resources, especially when a company is involved in new product approvals and introduction, expanding operations, technology transfer, and changing customer, regulatory or certification requirements.
Knowledge and Experience
Rely on 36 years of industrial experience in large-scale fermentation and contract manufacturing, from bench and chief microbiologist to vice president regulatory and legal affairs, in companies serving a broad range of markets from FDA regulated food, feed, dietary supplements, and starting materials for API’s, to fine chemicals and microorganisms under EPA TSCA and FIFRA, with raw materials and microorganisms requiring permitting under such areas as USDA, TTB, and DEA.
With deadlines for FDA’s new FSMA rules looming just ahead, utilize Simple Compliance Solutions for regulatory analyses and strategies for FSMA compliance, especially customized to the particular client and leading to more detailed assistance in meeting deadlines.
Pull in Simple Compliance Solutions when you are heavily involved in new products, new construction, technology transfer, and changing customer, regulatory or certification requirements.
we couldn't have made it without her...
Flint Harding, Business Development
I worked with Rachel for over 20 years, first as partners in FermPro Manufacturing, LP and then as employees of Martek Biosciences Inc. The main activities of FermPro were to introduce, scale up, and routinely produce food grade ingredients via large scale fermentation and downstream purification processing. Over the years, dozens of new products were introduced. Of course, Quality Assurance, was an essential and key part to every project. Rachel was directly involved with these projects starting with initial tech transfer, pilot runs, and routine production. Rachel skillfully managed challenging and complex situations involving GM strain approvals, OU kosher approvals, HACCP, process documentation requirements, customer and FDA audits, QC testing, and change management.. This expertise carried over with her work at Martek. It’s no understatement to say “we couldn’t have made it with our her.” Rachel has wonderful communication skills and a wealth of experience.
As a Fermentation Scientist, supporting production process improvement and introducing new fermentation processes for food grade ingredients on the Kingstree site, I worked for about 20 years with Rachel. She was our “Tower of Strength,” dealing with all the aspects concerning permits and approvals for introducing the new processes and production organism, various QA requirements, QC test plans and required documentation. I appreciate her extensive experience and her great cooperation!
Technology & Manufacturing Advisor
I worked with Rachel Montgomery while a Vice President for Martek Biosciences. She was our “go to” person on all regulatory issues related to products and plant operations at our Kingstree Production facility. She handled all FDA inspections and customer visits and maintained excellent relationships by being responsive to any concerns or suggestions. She provided professional advice on any questions that arose and excelled at follow through on tough items. Her opinion was trusted and she did everything in her power to make sure people were aware of FDA requirements and that they followed them.
Vice President Global Supply Chain & Manufacturing
Valent BioSciences Corporation
Rachel Montgomery has extensive experience in the various aspects (quality, regulatory, environmental, GMO etc.) of compliance for products produced by large scale fermentation and used in e.g. food and feed applications
Piet van Dijck
Consultant (and formerly Strain Director)
Mrs. Montgomery is an FSPCA Lead Instructor (Human Foods Certificate # 32c592bd, Animal Foods Certificate # 1bd2c691, Foreign Supplier Verification Programs Certificate # f3830814) with over 30 years experience as a food safety executive in large-scale manufacturing. Montgomery is the Principal of Simple Compliance Solutions, LLC and a Registered Microbiologist (National Registry of Certified Microbiologists). She can deliver the Preventive Controls course at your in-house or preferred location. Montgomery also provides consulting (See details on the Consulting Services page).