Quality Associates, Inc. provides regulatory consulting services to pharmaceutical and agrochemical industries. From our inception in 1986, quality assurance has been the cornerstone of QAI.
QAI offers the flexibility afforded by having eleven consultants, all with scientific professional experience, as well as, a European partner, GXP Engaged.
QAI offers the following services and solutions:
- Establishment of GLP Programs
- Act as the independent Quality Assurance Unit
- Support of Existing Quality Assurance Units
- Standard Operating Procedures Development
- Scientific Support
- Third-Party GCP Auditors
- Electronic Records and Electronic Signatures Support
- GLP Archiving
QAI provides contract quality assurance services under the following regulations:
- FDA Good Laboratory Practice Regulations for Non Clinical Laboratory Studies.
- EPA FIFRA Good Laboratory Practice Standards.
- EPA TSCA Good Laboratory Practice Standards.
- OECD Principles of Good Laboratory Practice.
- FDA/ICH Good Clinical Practice.
Quality Associates, Inc. provides scientific support for study conduct in the registration of pesticide products.
QAI’s experienced scientists can help you when your internal resources do not allow for sufficient study oversight. QAI personnel can operate as study directors, study monitors, or principal investigators.
Scientific Support offers the following services and solutions:
- Design and write protocols
- Technical evaluation of protocols
- Study management
- Technical data reviews
- Study report preparation
- Technical review of reports
- Submission reviews
- Preparation of report summaries
- Preparation of electronic submissions
- Preparation of regulatory rebuttals
- Fulfill study monitor/director responsibilities
- Identify & qualify contractors