Quality Assurance And Regulatory Affairs

Ricerca understands the cornerstone to all research relies on stringent quality assurance and regulatory affairs. We have put in place standard operating procedures dedicated to Good Laboratory Practice (GLP) and Good Manufacturing Practice (cGMP) standards for auditing and compliance.

Quality Assurance
The auditors at Ricerca are assigned to your project from its initiation and full compliance is assured through in-life, in-process, protocol, data, documentation and report audits conducted on every study or project. Our standard operating procedures (SOPs), test methods and training documentation are all issued and maintained under strict document control by our quality assurance group. Our team and processes assure regulatory compliance with FDA, EPA and OECD requirements and guidelines that include but are not limited to GLPs, cGMPs and specifically ICH Q7 guidelines.

Throughout the progress of your study, all documents/data are archived to assure complete and accurate documentation in addition to the retention to regulatory requirements. All validation/qualification programs are coordinated through validation specialists on our team in conjunction with the operational divisions and the corporate computer validation committee.

While our focus and dedication for our quality assurance staff is internally driven, the associates are available for consulting audits if requested.

Regulatory Affairs
Regulatory specialists are available on staff to assist our clients with:

• Regulatory and strategic consultation for early stage drug development
• Preparation of Chemistry, Manufacturing and Control (CMC) and Toxicology/Pharmacology regulatory submissions (eCTD Format)
• Consultation, representation and coordination of pre-IND (PIND) meetings with FDA
• Regulatory preparation and consultation for IND submissions
• Chemistry, Manufacturing and Control (CMC) changes, process optimization, technology transfers and/or validation planning