• QMS Remediation and SOP Rationalization for Audit-readiness

    The client is an India based fast growing medical devices company. The client approached Freyr for Regulatory support with carrying out audits for its manufacturing facility, Quality Management System (QMS) remediation and Standard Operating Procedure (SOP) rationalization. Since the client was ISO 13485:2003 certified, the challenge was to upgrade the organization to ISO 13485:2016 standards.

    Read the case to know how Freyr managed to complete the project within two weeks and prepare the client for audit-readiness.

  • Quick TAT for GCP Audit Services

    A South Korea based leading global pharmaceutical company approached Freyr to assess the suitability of study data of its European Union submission and applicable Good Clinical Practices (GCP). Since the study was already conducted, Freyr had to carry out the audit in retrospection. The major challenge faced by Freyr was the strict timeline of two weeks and to go through the bioanalytical data of the client which was not at all audit ready.

    Download the case study to know how Freyr managed to complete the project with quick TAT and saved up to 40% cost.

  • Time-critical Audit Services For Significant Cost Savings

    The client is a USA based one of the global top 5 pharmaceuticals company. Due to the traditional procedure of SOPs, the client approached Freyr to standardize and rational thousands of its SOPs to 300-400. Freyr managed to complete the entire audit process within two weeks while saving up to 40% of the cost.

    Read more to know how Freyr streamlined the process and carried out the project effortlessly.

  • QMS Remediation and Gap-Analysis Services

    A USA based top pharmaceutical company approached Freyr for Regulatory support with Quality Management Systems (QMS) documents remediation. The client required Regulatory assistance with reviewing its existing documents, performing gap-analysis and SOPs authoring based on the gap-analysis.

    Download the case study to know how Freyr provided quality deliverables while adhering to strict timelines.

  • QMS Remediation and Audit Finding Closures in Saudi Arabia

    To close 8 of its external audit findings, a Saudi Arabia based client approached Freyr for Quality Management Systems (QMS) remediation and audit findings. The major challenge was to draft responses for closing the audit findings within 10 days. Another challenge faced by Freyr was that the company did not have internal QMS, hence, the Regulatory partner had to come up with Corrective Actions and Preventive Actions (CAPA) which could be implemented practically.

    Read more to know how Freyr managed to complete the project under strict timelines.

  • CAPA, RCA, and Audit Finding Closures within Two Days

    One of the top generic companies based out of USA approached Freyr to address and close 17 of its Regulatory audit findings (nine 483s). The client required support from Freyr in drafting response for the findings within two days along with Corrective Actions and Preventive Actions (CAPA) and Root Cause Analysis (RCA). How did Freyr assist the client along with an Establishment Inspection Report (EIR) and a detailed risk-benefit analysis? To understand, download the case study.

  • Successful Execution of Validation Procedure

    The client is a leading India based pharmaceuticals company, which was looking for a Regulatory partner to carry out audit for its cleaning procedures and documentation. Freyr provided Regulatory support to the client by creating validation master plan, project validation plan and cleaning validation protocols. The major challenge faced by the client was collating all the necessary information required for the audit process.

    To know more about how Freyr executed the project while adhering to all the compliance requirements under two weeks, download the case study.

  • On-site Physical Audit to Remote Audit - A Risk-based Approach for Transition

     

    Remote Audit (Virtual Audit) Services - Overview

    It is a known fact that drug manufacturers must work relentlessly on vaccine development and emergency product manufacturing to control health crises like COVID-19. In such scenarios, what if the manufacturers or regulators have no option for onsite audits? What options do they have to audit vendors located in different geographies across the globe? The only option is to move from a traditional audit to a remote audit process or virtual audit.

  • End-to-End Compliance Services

     

    Quality Audit and Compliance Services - Overview

    Freyr is flexible and attentive to client-specific needs in providing quality compliance consulting. Its proven expertise in audit and compliance services and specialization in Regulatory and cutting-edge technology can establish a centralized, cost-effective, high-quality, and end-to-end audit and compliance services proposition for an organization’s compliance assurance.

  • Successful GMP Audit Services at Manufacturing Facilities

    A fast-growing U.S. based company, developing APIs and formulation, was looking for assistance from Freyr to audit their API and formulations Suppliers. Location of the API and formulation manufacturing facilities was a major roadblock for the team as conducting two separate audits at different facilities had to be carried out.

    Read through the case to know Freyr’s approach in carrying out the entire Audit process.

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