Quality assurance is a vital component of any drug development program. SWG offers a variety of quality assurance services tailored to a client’s business model and project specific requirements. With a combined experience of 30 years, SWG offers quality assurance management for emerging companies as well as small-mid sized pharmaceutical companies. We can provide ad-hoc services or full QA oversight to ensure that your program and studies can withstand regulatory scrutiny.
Quality Assurance Development
To ensure adherence to strict quality guidelines, Swiftwater Group helps clients develop a Quality Assurance/Quality Control program and develop and manage Standard Operating Procedures (SOPs).
Work with client to develop a quality program to fit the company’s needs by clearly defining quality policies and drafting quality plans/manuals
Determining set of SOPs required
Drafting individual SOPs
Training sponsor employees on proper SOP adherence
Auditing compliance to established internal SOPs
Analyzing gaps in an established program and recommending process improvement measures for bottlenecks in the process
Providing due diligence evaluation of a QA system prior to partnering or licensing discussions
In addition Swiftwater Group can train clients (Sponsors) on proper adherence to applicable regulations (GMPs, GCPs, GLPs) as well as general quality assurance oversight as needed.
Vendor Qualification/Audits and Reporting
SWG offers experience in detailed evaluation and qualification of vendors providing drug development services governed by a regulatory authority (i.e. FDA, EMA, and/or Health Canada).
Vendor Qualification/Audits and Reporting for vendors (Analytical and Bioanalytical labs, clinical CROs, clinical sites, CMOs, clinical packaging units, toxicology facilities, system audits (electronic/IT systems, environmental monitoring, IVRS), central labs, data management) both domestic and international.
Detailed reporting of observations and findings in a comprehensive report complete with corrective and preventive action recommendations
Documentation Review
Swiftwater Group offers quality control review in support of the CMC, nonclinical, clinical, or regulatory program of a drug development project. This includes general QA/QC review and oversight of GXP documentation such as:
Nonclinical and Clinical Study Reports
CMC documentation such as methods, batch records, packaging work orders, labeling
Regulatory submission documents
Regulatory Inspections
Passing regulatory inspections is vital to the approval of any drug. SWG can assist Sponsors/clients in preparing for
General surveillance or for-cause inspection occurring at the Sponsor or at a vendor site
