Our in-depth knowledge of our products, processes, regulations provides our customers with:

• Technical data pertaining to product manufactured, ranging from components to process and systems.
• In-house laboratory testing for all incoming materials and finished products.
• Timely and complete technical and regulatory support.
• Robust quality systems to support all aspects of manufacturing operations and processes.

Quality Assurance and Regulatory

To alleviate consumer concerns and ensure quality products in the dietary supplement industry, FDA worldwide 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, Briyosis 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.
• 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 around the world, facilitating optimization of product registrations for customers.
• NAFDAC, WHO-GMP certified.

Quality control

Briyosis Quality Control

Within the Quality Control division at Briyosis, there are two critical groups who work to support all different functional areas internally as well as serve external needs.

Technical Services

At Briyosis, quality plays a critical role and is present from the beginning. At the point of product conception, the technical services team provides support for product specifications, descriptions, critical attributes and controls towards the unique requirement of the product. For new product concepts, a team is in place for a review process of all materials, claim accuracy, and overall product assessment. Technical services work in collaboration with our R&D team as well as our clients to compile all necessary documents required of the product. Every product is unique and requires an assessment to be performed on a product by product basis.

2,500+ unique formulations. 2,000+ unique raw material codes.

Quality Control Laboratory Services

Within the Quality Control suite, comprised of three separate laboratories dedicated to method development, optimization and verification, Briyosis is equipped with dynamic testing capabilities which allow all raw materials to be QC analyzed prior to release for use in manufacturing through finished product QC analysis for issuance of Certificates of Analyses. Between our Analytical, Wet Chemistry, and Microbiology laboratories, our testing services and capabilities include active marker analysis, potency, identification, assortment of contaminant analysis, microbial, rupture analysis, physical analyses from raw material to finished product, and even product stability evaluation and programs. With a team of knowledgeable and experienced analysts, methods have been developed and scientifically verified to ensure accuracy of the results. Raw materials through finished products are tested to ensure the claim and the overall consistent quality of the soft-gels manufactured at Briyosis.