Quality of service is everything.
Your project is unique so we customize our services to your individual project. General project details will be understood with an initial conversation. With the confidential sharing of additional details a quote customized to your project and goals will be crafted.
Upon acceptance of a satisfactory quote you can expect additional conversations with our technical staff. As the project proceeds clear communication, timeline visibility, and regular updates will be provided.
In all our services, quality is of the upmost importance. Experiments are conducted to elicit the most relevant information possible and guide further development. Clinical supplies and commercial products are manufactured in our cGMP facility with Quality Systems oversight.
Key components of our quality system include:
Independent QA: An independent quality assurance function ensures quality is a top priority. QA is responsible for the release of all incoming ingredients, equipment cleaning and finished product.
Training: Our people are your most valuable asset. Initial and ongoing training is critical to ensuring procedures are known and followed.
Auditing & Review: Compliance is not a onetime activity. Ensuring your product is crafted with impeccable quality takes a commitment to ongoing improvement. We regularly review our procedures for effectiveness and compliance.
Supplier Controls: A formulation and process are only as good as the quality of the ingredients. Our supplier qualification and management system evaluates suppliers before manufacture starts. Monitoring continues during prodcution to proactively address quality issues before they affect product quality.
Equipment Qualifications and Calibration: Our manufacturing and testing equipment are qualified, calibrated and maintained within the quality system. Proactive evaluation of equipment ensures product quality is not diminished.
Records Management: Our records are essential to ensuring compliance with cGMP. In addition, these records provide a window into the performance of your product. Our independent QA maintains and audits these records on a regular basis to ensure integrity and completeness.