Compliance Insight: Hands-On Quality and Regulatory Specialists

May 6, 2013 - PRLog -- Compliance Insight, Inc. specializes in Regulatory and Quality Assurance consulting and training for pharmaceutical, nutraceutical, medical device, chemical, and bio-technology companies in North America, Europe and Asia.

The many facets within the industry that we serve and who market their products in the U.S. include,

·      Clinical trial investigator

·      Pharmaceutical

·      Nutraceutical

·      Medical device

·      Chemical

·      Biotechnology

·      Food industries

These highly regulated industries are required to maintain compliance with FDA regulations in order to market their products in the U.S.  Support industries such as contract testing labs, raw material and component suppliers, and contract manufacturers are also subject to these regulations.

If these statements are true for you, then Compliance Insight can help!

Our QA department is overburdened and overworked!  We don’t have the time or people to do our GMP training.

·      We received a warning letter from the FDA.  How do we respond?

·      We are preparing for a pre-approval inspection for a new drug product. We want to be ready and have the inspection proceed as smoothly as possible.

·      We are a manufacturer of dietary supplements.  

·      What do we need to do to insure that our product meets the new FDA dietary supplements regulations?

·      We need to qualify a new supplier for one of the active ingredients in our drug product.  We need a third party to inspect the manufacturing facility.

·      We need to make a change to the manufacturing process for our drug product.  Does this change require prior approval from the FDA?

·      We are a manufacturer of active pharmaceutical ingredients.  We need someone to develop a drug master file for our new product.

·      We manufacture chemicals but we want to start to supply an active pharmaceutical ingredient.  

·      What do we need to do to comply with API regulations?

·      How do we know if our validation protocol is adequate?  We need an expert to review it.

Clients are likely to be successful working with us if…

·      You want to achieve a higher level of compliance and maintain top quality standards.

·      You are ready to take action and implement strategies needed to control the success of your business.

·      You are honest and run your business with integrity.

·      You are willing to do it right and not take shortcuts.

·      You are willing to commit the people and resources necessary to complete the project in a timely and thorough manner.

For more information visit http://compliance-insight1.com/