Life Science Services: GxP Compliance and Quality Assurance Solutions

FDA Quality and Regulatory Consultants (FDAQRC) embodies a steadfast commitment to excellence, which is evident in our exceptional life science services that are tailored to enhance your regulatory compliance. Our consultant network includes former FDA and Health Authority experts, allowing us to tailor solutions and expand support that meet your unique project needs.

 

Our Approach to Life Science Compliance Solutions

Since 2009, we have offered comprehensive support for Good Practices (GxP) compliance solutions. Our expertise has taught us that every project’s needs evolve, and we can assist you every step of the way. Our range of services includes mock inspections, quality audits, recruitment, gap assessments, and more, ensuring we can cover all your project requirements.

Expertise In
All Aspects

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 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 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 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)

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

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

GxP Compliance Services for Life Science Organizations

Using GxP compliance, we provide product life cycle compliance support. Our expertise and techniques can help life science companies create healthier and safer products using more efficient processes.

Our GxP Compliance Services

GxP compliance is a comprehensive list of services that work to maintain product quality, safety, and integrity across the pharmaceutical, biotech, and medical device industries. Our GxP compliance solutions include:

  • Good Clinical Practice (GCP)
  • Good Manufacturing Practice (GMP)
  • Good Laboratory Practice (GLP)
  • Good Clinical Laboratory Practice (GCLP)
  • Pharmacovigilance services (GVP)
  • Computer System Validation (CSV)
  • Good Distribution Practice (GDP)

Specialized Life Science Consulting Services

FDAQRC provides a wide range of specialized life science consulting services to enhance product safety and reduce the threat of recalls.

Quality Assurance Services for Pharma and MedTech

Quality assurance involves processes to help your products meet specific quality standards and customer expectations. Our integrated quality assurance services can provide your company with peace of mind from the research process to product distribution:

  • Quality Assurance Audits
  • Quality Management System
  • Qualified Person (QP) support

Remediation Services

Remediation services can identify, correct, and prevent noncompliance issues related to regulatory requirements, assisting our clients with FDA warning letters and providing continuous improvement practices through training and consulting.

Inspection Readiness

Inspection readiness (IRS) processes prepare your product for an audit or regulatory inspection. Our team will help you accurately complete documentation and confirm your processes are readily available and verified.

Qualification and Validation Service

Qualification and validation services ensure your equipment, systems, and processes meet predefined specifications or regulatory requirements. Our team provides these crucial services to help your company maintain compliance, create consistent product quality, and minimize operational risks.

Life Sciences Recruitment

Recruitment services connect qualified professionals with your organization. FDAQRC’s recruitment department sources top-quality candidates for various roles, ensuring the right fit through an extensive screening process.

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.

Supporting Life Science Companies Throughout the Product Life Cycle

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 Life Science Regulatory Expertise

Countries highlighted represent areas where FDAQRC has completed recent work.

FDAQRC offers international pharmaceutical quality consulting, proudly leveraging a global consultant network and showcasing our commitment to providing top-tier quality and regulatory services. With over a decade of experience spanning 70+ countries and connecting with over 500 consultants, our powerhouse team excels in all GxP areas, addressing the diverse needs of industries worldwide.

Request a Life Science Services Consultation

Together, we can transform the life sciences industry, delivering healthier and safer products for consumers. Contact our experts to request your personalized service consultation today.

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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