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.

New Services

As part of our ongoing commitment to excellence, FDAQRC has expanded its services to include Remediation, Recruitment, and Qualified Person (QP) support. Our Remediation Department assists clients with FDA warning letters and continuous improvement practices through training and consulting. The Recruitment Department sources top-quality candidates for various roles, ensuring the right fit through a thorough screening process. Our QP service offers certified experts to help clients navigate regulations for exporting biotech and pharmaceutical products to the United Kingdom and European markets.

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Computer System Validation (CSV)

Gap Analyses | Remediation Plans | Standard Operating Procedure (SOP) Development & Review | Inspection Readiness Programs | Quality Manuals | Vendor Questionnaires | Ad Hoc QMS Consulting

Good Clinical Practices (GCP)

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

Good Laboratory Practices (GLP)
& Good Clinical Laboratory Practices (GcLP)

Vendor Audits | Qualification and Re-Qualification Audits | Routine Audits | For Cause Audits | Facility Audits | Study Audits | Data Audits | Document Reviews | Process Audits | System Audits

Good Manufacturing Practices (GMP) &
Good Distribution Practices (GDP)

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

Good Pharmacovigilance Practices (GVP)

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)

Inspection Readiness (IR)

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

Recruitment

Permanent, Interim & Contract Staffing Solutions | Job Posting Promotions | Candidate Recruitment

Target Discovery & Lead Discovery

Ensure quality and integrity of non-clinical laboratory studies through Good Laboratory Practices (GLP).

Lead Optimization

Through Good Laboratory Practices (GLP), ensure quality and integrity of non-clinical laboratory studies.

Pre-Clinical

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.

Phase 1

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.

Phase 2

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.

Phase 3

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.

Approval Launch

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.

Commercial Product

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.

Your Path to
Regulatory Compliance

FDAQRC is renowned for our comprehensive, custom-tailored customer service, a project management model built on global experience and expertise, and a supportive, collaborative approach that ensures efficiency and clear communication. With a history of repeat customers, here are our top requested services…

Good Clinical Practice (GCP)

FDAQRC provides a wide range of services for GCP projects in the pharmaceutical and biotech industries. Our employees and our global network of consultants are experienced professionals that can offer comprehensive solutions for Vendor Audits, Investigator Site Audits, For Cause Audits, Mock Pre-Inspection audits and more. Our team is here to ensure your clinical trials reflect the highest standards and industry best practices.

Inspection Readiness

FDAQRC remains the foremost provider of tailored inspection readiness solutions. Our dedicated team specializes in preparing clients for inspections by FDA, MHRA, EMA, and other health regulatory agencies. Our experts excel in crafting personalized inspection readiness tracks that address each client’s specific needs. With a team comprised of former inspector experts, we bring invaluable hands-on experience and regulatory insights. We are fully equipped to support you comprehensively in your preparations for upcoming agency inspections.

Good Manufacturing Practices (GMP)

FDAQRC continually showcases our unparalleled expertise in the sphere of GMP. Our GMP service offerings include Mock Pre-Inspection Audits, Vendor Audits, GAP Assessments, CMO Audits, and more. FDAQRC’s project managers and auditors are highly qualified to ensure your GMP project processes excel in safety, quality, and consistency.

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.

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INDUSTRY INSIGHTS

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