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Q.C.R.A. Consulting
Quality Compliance & Regulatory Affairs



Q.C.R.A. Consultant(s) is helping leaders make distinctive, lasting, and substantial improvements to the performance of their organizations. As a result of our industry focus and in-depth expertise, we can help you tackle your most complex and specialized challenges, assist you in developing strategic and operational plans, improve the efficiency of your internal operations, and put the company on the right track towards proactive and sustainable compliance.

As a life-sciences consulting company, our business is to ensure that your business does not experience regulatory setbacks or delays caused by complications.

A full-service regulatory business, we guide your organization through successful quality audits, manufacturing inspections and product submissions.

We are a team of experts in science, regulatory and quality who protect your investment in research and development, intellectual property and business operations.

It is important to us that your business and your employees are well taken care of. That's how we build trusted relationships with our clients.

Working with Q.C.R.A.

The Compliance Team provides subject matter experts who are familiar with your business challenges and can help you achieve your quality compliance goals. Our experts will identify quality standards that fit the situation based on an understanding of the subject area. 

Quality Compliance | Regulatory 

  • Suppliers Qualifications & Third-Party Audits 

  • Internal Audit Program Support 

  • GMP, GLP, GDP, PV & ISO Inspections 

  • Compliance Gap Assessments 

  • SOP and Policies review, update and creation

  • Annual Products Review 

  • CAPA, Change Control, Complaints & Investigation 

  • Quality System Support (Including quality manuals, Responsible distribution manual, HACCP manual and H&C Manual)

  • Emergency Response/Media guide

  • Risk Management

  • Procedure Design and Revision 

  • Batch Records Review 

  • Document Management & Control (GMP Records)

  • Management Review

  • Controlled Substances/Narcotics, Precursors (A & B) & Cannabis

  • Food compliance

  • Import & Distribution activities

  • Hazardous Materials

  • Health & Safety

  • Product registration and licensing

  • Training 

  • The key to successful quality is a culture of quality. Most corporate cultures lack the components necessary to establish a culture of quality.

  • A foundation that supports the implementation of quality programs is provided by a culture of quality.

  • The most important factors in predicting the outcomes of quality in an organization are cultural characteristics of quality.

  • The level of understanding and adherence to our quality concept and approach among all employees, as well as the amount to which they have incorporated quality into all they do, may be determined by evaluating our existing culture of quality.

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