Compliance, Audit and Validation

Ensuring compliance across pharmaceuticals, biotechnology, and medical devices, covering GxP, ISO, and FDA regulations. Our expert audit preparation and validation services streamline processes for global quality standards.

  • 20

    +

    Experts
  • 5000

    +

    SOPs Created, Reviewed & Harmonized
  • 50

    +

    Customers/Clients
  • 55

    +

    Project SOPs
  • 35

    +

    No. of Programs
  • 600

    +

    External SOPs
  • 6
    Types of Audits Performed
  • Zero
    Recalls

Compliance, Audit and Validation - Overview

Are you compliant? This is a question that any pharmaceutical, biotechnology, genomics, chemical, medical device, and supply chain management company finds challenging to answer. These organizations must comply with stringent quality, safety, and compliance requirements in each geography where their products are distributed. The current Regulatory compliance management trend is moving towards global harmonization of quality and safety. Whether you are a manufacturer or a supplier, your market expansion, continual improvement, and customer satisfaction rests principally on the quality standards of your business. Freyr’s Regulatory Compliance, Audit and Validation Center of Excellence (CoE) can help in this effort by assisting you with professionally-aided Compliance, Audit and Validation Services for Pharmaceuticals, Medical Devices, Consumer, and healthcare industries such as cGMP (Current Good Manufacturing Practices), GCP (Good Clinical Practice), GDP (Good Distribution Practice), Good Laboratory Practice (GLP), GPVP (Good Pharmacovigilance Practice), and GxP Computer System Validation (CSV).

Freyr provides Regulatory Compliance, Audit, and Validation Services that involve evaluating your requirements and suggesting inputs to business processes designed to assure customer satisfaction. With our compliance audit report preparation and readiness strategies, we provide compliance and audit (gap analysis) reports, including suggested Corrective and Preventive Actions (CAPA) to avoid potential 483s and audit findings from regulators.

With uniquely designed in-house and on-demand audit management systems, Freyr ensures that all your processes and products are aligned with applicable quality, information security, and Regulatory compliance audit requirements, such as (but need not be limited to) the following:.

We provide Regulatory compliance and validation services to ensure that all your processes and products are aligned with the applicable quality, information security, and Regulatory compliance audit requirements such as (but need not be limited to) the following:

Compliance, Audit and Validation

Freyr performs around 700 checks at a preliminary level spread across 18-19 GMP functional areas

Freyr’s Compliance, Audit and Validation

Compliance, Audit and Validation

Quality and Regulatory Compliance – Current Good Manufacturing Practices (cGMP)

  • ISO / IEC 17025: 2017 - General Requirements for the Competence of Testing and Calibration Laboratories
  • OECD (Organization for Economic Co-operation and Development) - Guidelines of Good Laboratory Practice
  • EURACHEM / CITAC Guide: Guide to Quality in Analytical Chemistry - An Aid to Accreditation, 3rd Edition (2016), should be followed in analytical procedures
  • 21 CFR 58: Good Laboratory Practice for Non-Clinical Laboratory Studies
  • Guide to UK GLP Regulations, Feb 2000 (by GLPMA)
  • WHO Handbook on Good Laboratory Practice (GLP): Quality Practices for Regulated Non-Clinical Research and Development
  • Health Canada: Finalized Guidance Document - Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice
  • OSHA (Occupational Safety and Health Administration) Standards
  • Applicable ICH Guidelines

Good Laboratory Practice

  • ISO / IEC 17025: 2017 - General Requirements for the Competence of Testing and Calibration Laboratories
  • OECD (Organization for Economic Co-operation and Development) - Guidelines of Good Laboratory Practice
  • EURACHEM / CITAC Guide: Guide to Quality in Analytical Chemistry - An Aid to Accreditation, 3rd Edition (2016), should be followed in analytical procedures
  • 21 CFR 58: Good Laboratory Practice for Non-Clinical Laboratory Studies
  • Guide to UK GLP Regulations, Feb 2000 (by GLPMA)
  • WHO Handbook on Good Laboratory Practice (GLP): Quality Practices for Regulated Non-Clinical Research and Development
  • Health Canada: Finalized Guidance Document - Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice
  • OSHA (Occupational Safety and Health Administration) standards
  • Applicable ICH Guidelines

Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP)

  • ICH Harmonized Tripartite Guideline: Guideline for Good Clinical Practice - E6
  • E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files
  • E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)
  • Other Applicable ICH Guidelines
  • Guidelines on Good Pharmacovigilance Practices (GVP) Modules
  • FDA Safety Reporting Requirements for INDs and BA/BE Studies
  • Post Marketing Safety Reporting for Human Drug and Biological Products Including Vaccines
  • FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System (FAERS)
  • Providing Submissions in Electronic Format – Post Market Non-Expedited ICSRs Technical Questions and Answers
  • E2E Pharmacovigilance Planning

Information Security, Data Privacy and Computer System Validation (CSV)

  • ISO 27001: 2013 Information Technology – Security Techniques – Information Security Management System – Requirements
  • ISO 27002: 2013 Information Technology – Security Techniques – Code of Practice for Information Security Management
  • USFDA 21 CFR Part 11: Electronic Records; Electronic Signatures – Scope and Application
  • EU GMP Guide Annex 11
  • Japanese ERES Guideline Notification No 0401022
  • GAMP 5: A Risk-based Approach to Compliant GxP Computerized Systems
  • USFDA – Software Validation Guidelines
  • Applicable ICH QSEM Guidelines
  • Plan and create SOPs and control manufacturing facilities
  • Integrated process model
  • Maintain brand image
  • Overall cost savings
  • Implement effective and compliant business processes
  • Establishing validation and qualification strategies

Explore our Regulatory compliance and validation services

Success Stories

Freyr Supported in Post-Acquisition Management Support Services Establishes Integrated Processes and Systems for an Indian Multinational Pharmaceutical Giant
Compliance and Audit Services

Freyr Supported in Post-Acquisition Management Support Services Establishes Integrated Processes and Systems for an Indian Multinational Pharmaceutical Giant

The customer is the fourth largest global specialty generic pharmaceutical company with a significant presence in over 100 countries and a diverse portfolio of medicines addressing chronic and acute treatments. As client lack in-house expertise to establish a management system, they are seeking Post-Acquisition Management Support Services from Freyr, they engaged in validating Regulatory Standard Operating Procedures (SOPs) to establish a stable process aimed at minimizing the risks of non-compliance and its associated consequences.

Freyr Supports Global GxP Compliance Audits for French Multinational Pharmaceutical Company: Audits Over 90 Vendors
Compliance and Audit Services

Freyr Supports Global GxP Compliance Audits for French Multinational Pharmaceutical Company: Audits Over 90 Vendors

The client, a French multinational pharmaceutical company, encountered challenges in establishing a robust use management system to oversee their current systems and services. Seeking assistance from Freyr, they engaged in GxP audit services encompassing over 90 vendors, ensuring strict adherence to guidelines even amidst the pandemic. Freyr evaluated processes and the inter-relationships between the client's parent company and vendors, ensuring comprehensive compliance and operational continuity.

Freyr supported GMP Audit for UK-Based Pharmaceutical Company in 2 Weeks: GMP Audit Support
Compliance and Audit Services

Freyr supported GMP Audit for UK-Based Pharmaceutical Company in 2 Weeks: GMP Audit Support

The client, a leading UK-based pharmaceutical company, confronted challenges due to a lack of in-house expertise in complying with Good Manufacturing Practice (GMP) requirements. They enlisted Freyr's services to secure audit services encompassing GMP functions, procedures, and documentation practices within the UK region. Freyr proposed and conducted on-site audits for multiple products across various sites and geographic locations, resulting in significantly enhanced operational efficiency and Regulatory compliance.

Freyr Supports USA-Based Logistics Firm in Life Sciences Sector: Comprehensive Support to Achieve Full GDP Compliance
Compliance and Audit Services

Freyr Supports USA-Based Logistics Firm in Life Sciences Sector: Comprehensive Support to Achieve Full GDP Compliance

The customer, a global logistics transportation company based in the USA, facing challenges in understanding GDP relevance to their business. Approached Freyr's support in establishing a unified Quality Management System (QMS). This involved streamlining over 60 Standard Operating Procedures (SOPs) and regulations to ensure compliance with Good Distribution Practices (GDP) and obtain the GDP certificate, thereby maintaining high standards of quality and integrity.

Freyr provided Quality Assurance for UK-Based Technology Company: Strategic Solutions to Address Audit Gaps
Compliance and Audit Services

Freyr provided Quality Assurance for UK-Based Technology Company: Strategic Solutions to Address Audit Gaps

The client, a UK-based technology company focused on safeguarding and preserving customer data, encountered challenges in identifying gaps and addressing audit findings to enhance the overall system quality. Engaging Freyr's services, gaps were systematically identified, and a robust response was formulated. Freyr developed a QMS portal and implemented over 80 processes, ensuring comprehensive coverage. They also conducted thorough software validation, meticulously documenting each validation step to meet Regulatory requirements and enhance operational reliability.