Quality Assurance & Regulatory

To alleviate consumer concerns and ensure quality products in the dietary supplement industry, US FDA requires strict adherence to the set regulatory guidelines of dietary supplement operations. Effective enforcement of these regulations will not only protect public health, but serves to deter others from violating the law, inform the public of possible harm, create a quality standard and instill public confidence in the industry-at-large and the products thereof.

In order to provide the industry with such support and adherence, Captek Softgel International has established a strong Quality and Regulatory unit overseeing a robust quality system to assure that only the highest quality products are produced out of our operation. As a leading softgel contract manufacturer, we strive to provide excellence in global regulatory compliance and quality management.

This is how we reach that excellence:

  • Dedicated, thoroughly trained, and well equipped subject matter experts on our Quality and Regulatory staff.
  • Ongoing cGMP training program for all employees.
  • Effective Corrective Action and Preventative Action (CAPA) system.
  • Corporate quality standards and policies which drive to process specific Standard Operating Procedures, translating to consistently controlled quality operations.
  • A continuous improvement culture propelled through constant inspections, audits, assessments and analyses both internal and external. (Captek’s advocate and support of such continuous program is verifiable through an occurrence rate of averaging at minimum one external audit or inspection a week.)
  • Shiftly capture of quality review, assessed on a daily basis.
  • Timely and thorough responses to customer complaints and inquiries.
  • Experience in working with regulatory agencies in the US as well as around the world, facilitating optimization of product registrations for customers.
  • NSF, HALAL, MSC certified.
  • Maintenance of FSRN for Health Canada.