Medical innovation for a healthier world.
Recruiting Organisms to Revolutionize Healthcare
Biotech companies have been essential to the evolution of medical innovation and will continue to yield transformative technology that will help humanity battle the many issues it faces, from vaccination development to pharmacogenomics and everywhere between. To participate in these pioneering pharma or medical industries, biotech companies are beholden to the regulatory bodies that protect the general public from products deemed unsafe, adulterated, or otherwise incompletely evaluated.
Data Integrity is Critical to the Science
Data integrity and regulatory compliance is critical to the success (or failure) of a biotechnology manufacturing or testing facility. The Food and Drug Association (FDA) and other regulatory agencies have a commitment to ensure that any biotechnology products produced or sold are effective for their indications and safe for public consumption, with harsh penalties for those who do not act in accordance with 21 CFR Part 11 and other related standards. To comply with regulations enforced by these agencies, biotech companies have sought help from experts in pharmaceutical compliance and validations to ensure the data associated with their products adheres to Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA)+ principles.
Compliance is our Cause
ANSA Compliance has a mission to facilitate a seamless journey to compliance and help our clients meet their business needs. We come with a highly-experienced team in laboratory operations, manufacturing processes, equipment qualification, and computer system validations, ready to use our expertise to guide your business to efficient and compliant solutions.
Data integrity is our highest concern and will be achieved through a risk-based approach to the validation life cycle with respect to your company’s procedures and policies. Our team can lead coordination with project stakeholders and subject matter experts, perform impact assessments, draft validation documentation, and execute vigorous Installation, Operational, and Performance Qualification (IQ / OQ / PQ) testing.
ANSA is the Answer
ANSA Compliance is a service and staffing provider specializing in compliance and project management in regulated industries. Our promise is to provide a full-service experience including consultation, evaluations, remediations, solutions, document authoring, and enlisting experienced professionals to help our clients be more competitive and attain their business goals.