Antoniuk Consulting Services, LLC -- Quality Assurance Consulting for the Pharmaceutical and Biotechnology Industries
Quality Program Design
ACS specializes in assisting small, startup companies with meeting their quality and compliance requirements. ACS offers expertise to companies that may not have internal resources to implement or support required cGMP, GLP, and GCP programs. ACS offers gap analysis to determine compliance requirements, as well as drafting standard operating procedures, policies, and other controlled documents to support these programs. ACS can be used as a company's QA department or as a supplement to an internal QA department.
ACS provides inspections of potential or existing vendors, such as contract manufacturers, contract test labs, API manufacturers, service providers, and raw material suppliers. Comprehensive audit reports are provided to the client in a timely manner; inspection reports are provided in an approved hard copy, a digitally signed PDF scan, and electronically in the word processing program. After inspection, ACS can also follow up and work with the vendor to monitor corrective actions required from such inspections.
ACS provides data audit services for all types of data and documentation as related to pre-clinical and clinical development. This includes batch records, technical reports, method validation data, clinical data, toxicology reports, as well as environmental monitoring and validation data.
ACS offers training in the Current Good Manufacturing Practice (cGMP) and Good Laboratory Practice Regulations, including specialized topics related to these regulations. Training presentations can be standardized, or customized to reflect the company's existing compliance program.