Maintaining our drive for quality initiatives, our team of highly knowledgeable, skilled and experienced subject matter experts uphold our processes to stay ahead of our industry’s increasingly demanding regulatory and compliance needs. Our team is comprised of quality assurance, regulatory and compliance, quality control laboratory services, and technical services personnel who remain on the industry’s leading edge, uncompromising, manufacturing standards.
Dedicated to providing superior nutraceutical contract manufacturing and NutraStock® products worldwide, we offer technical support, quality control laboratory services, and quality assurance services.
Quality Control|Quality Assurance
Nutraceutical dosages require proper analytics and our team is equipped to handle these measures. Complex product matrices require analytical expertise not available at most other laboratories. Our quality control team provides these internally and externally in two ways:
Every product is unique and requires an assessment, having our team at the beginning of the process is critical. Whether it is product conception or product development, our team’s approach is meticulous and is handled on a case-by-case basis.
For new product concepts, we review processing of all materials, claim accuracy, and overall product assessment.
For products being considered for development, we provide specifications, descriptions, critical attributes, and controls to identify the unique requirement of the product.
Our technical services team collaborates with our research and development team along with our clients to compile all necessary documents required for the product. Certifications of Halal, organic, Non-GMO, allergen and other relevant documents are requested and reviewed to ensure all materials are appropriate for the product.
To better serve clientele with product testing, our quality control suite consists of four laboratories, with one dedicated to method development, optimization and verification. Between analytical, wet chemistry and microbiology laboratories, our testing services and capabilities include:
Active Marker Analysis
Product Stability Evaluation
Product Stability Programs
Clientele rely on our expertise to analyze, test and validate new and existing product offerings.
Our Quality and Regulatory teams manage a robust quality system to ensure that only superior products are manufactured. Having worked within stringent guidelines mandated by the FDA and other regulatory agencies, our reputation among companies within the VMS industry is highly regarded because we maintain a level of excellence through:
Process-Based Quality Initiatives
Certifications from NSF International
Batch Records of Quality Reviews
Document Control of Product Registrations
Regulatory Compliance, Nationally and Internationally
The effectiveness of ingredients in newly formulated nutraceuticals is rigorously tested to ensure that the integrity of the products are uncompromised. Understanding that consumer health is at risk, we adhere to stringent testing standards to affirm the products’ identity, strength, quality and purity. Our laboratory capabilities are second to none, and we are transparent in reporting findings.
Having tested thousands of unique formulas, our Quality and Regulatory teams, thoroughly examine every products, adhering to regulatory compliance standards, as well as metrics we’ve established for ourselves, upholding our reputation as a CMO of superior products. The primary testing services we provide are raw materials testing and stability testing.
CAPTEK® Softgel International is equipped with dynamic testing capabilities which allow all raw materials to be quality control analyzed. Testing of raw materials is performed to ensure the purity, quality and strength of the ingredients used to develop nutraceutical products, bulk stock softgel capsules and supplements.
With a team of knowledgeable and experienced analysts, our methods have been scientifically verified to ensure accuracy of the results for the raw materials we’re testing. Monitoring ingredient performance, beginning with the mixture of raw materials, our testing methodology aims to affirm the claim and overall consistent quality of the products manufactured at CAPTEK Softgel International.
Recognizing the growing need for brands to meet stricter regulatory requirements, our team provides stability testing services for dietary supplement products. Scientific data to support shelf life claims of dietary supplement products has made stability testing necessary, and we provide a variety of testing services that validate product integrity at numerous checkpoints:
This study is conducted under controlled conditions of 40°C (±2°C) with relative humidity at 75% (±5%) with testing performed at specific intervals. Sampling point and/or frequency will include the initial testing at (t0), 1 month, 2 months, 3 months, and/or 6 months depending on the study requested.
This study is conducted under controlled conditions of 25°C (±2°C) with relative humidity at 60% (±5%) with testing performed at specified intervals. Sampling point and/or frequency will include the initial testing at (t0), 1 month, 2 months, 3 months, 6 months, 9 months, 12 months 18 months, 24 months and/or additional yearly depending on the study requested.
CAPTEK Softgel International, Inc. fully complies to federal U.S. FDA GMP’s and has been independently certified by NSF International. We are also certified by other national and international entities.
Recognizing nutraceutical CMOs have an enormous effect on public health and the planet, we adhere to industry standards and consistently engage in continuing education to remain aware of consumer concerns, product recalls, pending regulatory mandates, health care policies and environmental issues.
Maintaining our commitment to excellence, our work ethic is reflected by the following certifications: