Expertise In
All Aspects

At FDAQRC, our goal is to provide tailored solutions to address your unique project needs. We excel in providing comprehensive support for projects in the realm of all GxP areas. We understand that your project’s needs may evolve, and we are ready to assist you at any stage of your journey. To meet client needs, we offer a wide range of capabilities. Our services include conducting various types of audits, such as investigator site audits (ISAs), vendor qualification audits, for cause audits, CRO/CMO audits, mock FDA inspection audits, CSV compliance audits, and GAP assessments. We can assist in developing and enhancing quality systems to ensure compliance and operational efficiency.

At FDAQRC, we embody a steadfast commitment to excellence, evident in our exceptional services tailored to enhance your regulatory compliance.

Gap Analyses | Remediation Plans | Standard Operating Procedure (SOP) Development & Review | Inspection Readiness Programs | Quality Manuals | Vendor Questionnaires | Ad Hoc QMS Consulting
GCP Vendor Audits | All Vendors | Qualification and Re-Qualification Audits | Routine Audits | For Cause Audits | Vendor Inspections | Investigator Site Audits | Routine Audits | For Cause Audits | Internal GCP Audits | System Audits – Sponsor; Contract Research Organization (CRO); Phase 1 | Database Audits – Data Management (DM) System Audits | Trial Master File (TMF) Audits | Document Audits
Vendor Audits | Qualification and Re-Qualification Audits | Routine Audits | For Cause Audits | Facility Audits | Study Audits | Data Audits | Document Reviews | Process Audits | System Audits
GMP Gap Analysis | Remediation Plans | Remediation Services | Facility Inspections and Audits | Drugs, Medical Devices | Packaging and Labeling | Warehousing, Storage and Distribution | Contract Manufacturing Organization (CMO) Audits | Vendor Audits | Mock Pre-Inspection Inspections (PAI) | Qualified Person (QP) Audits
QMS Audit | Internal Pharmacovigilance (PV) System Audits | PV Vendor and Process Audits | Qualification and Re-Qualification Audits | Routine Audits | For Cause Audits | Commercial Partner Audits | Risk Evaluation and Mitigation Strategies (REMS)
Mock Inspections | Former Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada Investigators | Inspection Readiness – Group Training | 1-on-1 Inspection Interview Training | Site Training | Site Mock Inspections | Trial Mater File (TMF) Review | Document Reviews | On-site Consulting During Inspections
Permanent, Interim & Contract Staffing Solutions | Job Posting Promotions | Candidate Recruitment
Ensure quality and integrity of non-clinical laboratory studies through Good Laboratory Practices (GLP).
Through Good Laboratory Practices (GLP), ensure quality and integrity of non-clinical laboratory studies.
For pre-clinical services, Good Laboratory Practice (GLP) ensures the quality and integrity of non-clinical safety studies, Quality Management Systems (QMS) establishes a framework for consistent quality across all activities, and Computer System Validation (CSV) ensures that computer systems used in data handling are properly validated.
For Phase 1, Good Clinical Practice (GCP) ensures the safety and ethical treatment of trial participants and the reliability of trial data, Quality Management Systems (QMS) maintain consistent quality across clinical trial activities, Computer System Validation (CSV) ensures validation of electronic systems used in clinical trials, and Inspection Readiness (IRS) prepares for regulatory inspections of clinical trial processes and data.

For Phase 2, Good Clinical Practice (GCP) ensures continued compliance with ethical standards and the reliability of trial data, Quality Management Systems (QMS) maintain consistent quality across clinical trial activities, Computer System Validation (CSV) ensures validation of electronic systems used in clinical trials, and Inspection Readiness (IRS) prepares for regulatory inspections of clinical trial processes and data.
For Phase 3, Good Clinical Practice (GCP) ensures continued compliance with ethical standards and the reliability of trial data, Good Manufacturing Practice (GMP) ensures the quality and consistency of drug production for large-scale trials, Quality Management Systems (QMS) maintain consistent quality across clinical trial activities, Computer System Validation (CSV) ensures validation of electronic systems used in clinical trials, and Inspection Readiness (IRS) prepares for regulatory inspections of clinical trial processes and data.

For Approval Launch, Good Manufacturing Practice (GMP) ensures quality and consistency in the manufacturing of the drug product, Good Distribution Practice (GDP) ensures the proper distribution of pharmaceutical products, Good Storage Practice (GSP) ensures the proper storage conditions for pharmaceutical products, Good Pharmacovigilance Practice (GVP) monitors and manages the safety of the drug after it has been approved, Quality Management Systems (QMS) ensure overall quality in all processes leading up to the launch, and Inspection Readiness (IRS) prepares for regulatory inspections during the approval process.

For Commercial Product, Good Manufacturing Practice (GMP) ensures the ongoing quality and consistency in the manufacturing of the drug product, Good Distribution Practice (GDP) ensures the proper distribution of pharmaceutical products, Good Storage Practice (GSP) ensures the proper storage conditions for pharmaceutical products, Good Pharmacovigilance Practice (GVP) continues to monitor and manage the safety of the drug, Quality Management Systems (QMS) ensure ongoing quality management throughout the product’s lifecycle, Computer System Validation (CSV) ensures that electronic systems used in manufacturing, distribution, and monitoring are validated, and Inspection Readiness (IRS) prepares for ongoing regulatory inspections throughout the product’s lifecycle.

From Discovery to Delivery, FDAQRC Offers Unwavering Quality

At FDAQRC, we embody a steadfast commitment to excellence, evident in our exceptional services tailored to enhance your regulatory compliance. From Target Discovery to Commercial Product stages, FDAQRC offers global comprehensive services across all GxPs. Our expertise in Quality Management Systems (QMS), Computer System Validation (CSV), and Inspection Readiness (IRS) ensures that every phase of drug development meets stringent regulatory standards. We support companies in navigating the complexities of Lead Optimization, Preclinical studies, and Phases 1 through 3 clinical trials with rigorous pharmacovigilance (GVP) and storage practices (GSP). By partnering with FDAQRC, pharmaceutical companies can confidently advance their drug candidates from discovery to market, knowing that every step is handled with the highest level of quality and regulatory compliance.

Global
Expertise

 

Countries highlighted represent areas where FDAQRC has completed recent work.

FDAQRC proudly leverages a global consultant network, showcasing our commitment to providing top-tier quality and regulatory services. With over a decade of experience spanning 70+ countries, our powerhouse team excels in all GxP areas, addressing the diverse needs of industries worldwide.

Trusted Partners

At FDAQRC, collaboration is at the heart of our work. We pride ourselves on working with a network of trusted partners that share our commitment to excellence and innovation in our industry. By endorsing these trusted partners, we aim to offer our clients solutions beyond our service offerings that will meet our standards of quality.

CONTACT

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