Our Vision: The essence of success is rooted in building effective relationships through open communication and clarity of common goals. To build relationships within the pharmaceutical and biotechnology industry and maximize impact, it requires maintaining a world-class level of expertise for both the company and our team.

 

Our Mission: To provide expert consulting services to pharmaceutical and biotechnology clients, building on their vision and existing systems by bringing innovative ideas and structured solutions. Working in tandem with clients to further strengthen their standing in the industry.

 

Our Focus: To be a strategic resource to the client and provide a rapid, cost-effective solution for compliance strategies and corporate risk-reduction. To simplify the complexity of global regulatory requirements. To streamline the compliance requirements and enhance corporate quality systems by using a quality by design (QbD) approach.



Global quality systems are built on the foundations outlined in the ICH (International Conference for Harmonization) guidance, Q7A - Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. Quality Management is comprised of principles; responsibilities of the Quality Unit(s); responsibility for production activities; internal audits (self-inspection); and product quality review.

Operational Areas within the Six Quality Systems
 
FDA's Six Quality Systems
     
 
 




Read more about the services offered by Compliance Strategies, Inc.

Quality & Compliance Systems
Process Definition, Mapping, & Streamlining
Development of Global Systems
FDA Readiness
System Audits & GXP Audits (cGMP, GLP, & GCP)
Due Diligence, Assessment, Vendor Qualification Program
Documentation, Data, & Batch Review