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U.S. Dietary Supplement Industry Compliance

Tap into a Network of Industry Experts with Years of Varied cGMP Experience to Support Your Quality Team

U.S. Dietary Supplement Industry Compliance

Tap into a Network of Industry Experts with Years of Varied cGMP Experience to Support Your Quality Team

What We Do

PREPARATION IS EVERYTHING!

In any federally regulated industry, your documentation, procedures, and overall compliance must be at their best at all times.

Being audited is a regular occurrence, and the most important ones are generally unannounced. We're here to help you with the background work that supports your Quality Team and prepares your Company for those events.

Our Expertise

The range of Dietary Supplement Industry Experience for Lori and her colleagues includes: Document template creation, Label review, Web copy and Marketing materials compliance, Supplier Qualification, Claims Substantiation research, Document Control, SOP's, Equipment Validation, Change Control, Deviations, Formula review, Work orders and so much more. Tap into Lori's network to get the help you need.

About Us

Experience

Lori Newburg started in the dietary supplements industry in 1987 as a bench chemist, before the Industry was highly regulated and consumers knowledgeable and savvy like we see Today.

From there she spent 23 years with a large contract manufacturer as the Industry changed and matured, creating both a Product Development Department and a Document Control Department from Zero to help satisfy the ever-changing compliance and customer service needs of a rapidly growing company.

Along the way she developed a reputation among colleagues, customers and suppliers for being (sometimes too) direct, (sometimes brutally) honest, and always a stickler for precision and accuracy. As a creative self-starter, she developed a variety of methods and tools for supporting both the company and their customers with information and documentation to be Compliant with cGMP.

Feel free to visit Lori's profile on LinkedIn:

https://www.linkedin.com/in/loribrooksnewburg/

Approach

Lori and her colleagues are Freelance Consultants, working by the project or by the hour depending upon the needs of the customer. Discussion by phone/video call will include the product(s) and/or regulatory sector and scope of work, to determine if we are a fit, which colleague has the expertise you need, and how best to proceed for your project.

Why Us?

Unless you've survived a grueling FDA Audit, you have not lived Compliance! Experience and Teamwork go a long way with preparing for that day when the Auditor walks through the door.

The basic auditor mantra is:

"If it's not written down, it never happened."

We can help with the preparation process, whether for a startup brand or an established company needing some fresh input and perspective. Whether it's Lori herself or one of her colleagues, we'll set you up with the best person for your needs.

CONTACT INFO

While we're located in South Florida, USA our new Work At Home environment easily allows for global collaboration! Reach out by using the messaging box below or send an email inquiry to Lori@newburgconsulting.com

or Call Lori at 754-225-4433.

U.S. Dietary Supplement Industry Compliance

U.S. Dietary Supplement Industry Compliance

Welcome

What We Do

PREPARATION IS EVERYTHING!

Our Expertise

About Us

Experience

Approach

Why Us?

CONTACT INFO