Pharmaceutical & Nutraceutical GMP Consulting

Q. What advice do you have for a customer looking to hire a provider like you?

A. More often than not, an organization or a company has a general sense of the regulations. But they just do not have the resources or skill sets capable of meeting their timelines. It happens. And when it happens, they need to consider asking for help. We are there to help and if we can't - we will say so. We are in the busy to establish a lasting and postive relationship. Our customers and their employees depend on accuracy and understanding. And we want them to be successful. Their success is our success. We understand the FDA regulations. We know how to apply them from words to practice.

Q. Why does your work stand out from others who do what you do?

A. We provide a comprehensive range of services that other consultants are not currently providing. For example, we can assist in project management, quality assurance, analytical methods/validation, formulation development and troubleshooting, and regulatory compliance and submissions. We also have a global presence whereas many consulting firms are more provincial.

Q. What do you like most about your job?

A. We enjoy the diversity. With each client comes a unique situation. Our experience, teamwork, and level of commitment is wonderful. We learn something new with each assignment.

Q. What questions do customers most commonly ask you? What's your answer?

A. How much experience do we have? How do we approach the needs of our customers? Typically, we would recommend a "gap assessment" to best identify what the customer may need towards their objectives. In some cases, the scope of work is fairly narrow. With others, it may be as a broad as establishing an entire quality system to support a regulatory submission. Each client has different needs and our experience tends to compliment those of our client's. We believe in customer service!