A leading US-based medical device manufacturer approached Freyr for QMS audit support for 21 CFR 820 and ISO 13485:2016 compliance. Amidst the current pandemic conditions, Freyr conducted a remote internal QMS audit through a strategic, phase-wise approach, as per the defined regulations in scope, with meticulous planning and by deploying certified auditors.

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A top USA based company approached Freyr to audit their Contract Manufacturing Organization’s (CMO) Good Manufacturing Practices (GMP). Since the client wanted to audit two of the facilities, the challenge was to collate and compile all the necessary information required to complete the audit as per the regulations of the target country in a short turnaround time.

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A USA based medical device company approached Freyr for Regulatory assistance with Good Manufacturing Practices (GMP) audit for two of its facilities. To ensure that the project was carried out smoothly, it was required to audit all the GMP functions and procedures, right from manufacturing equipment, design control and development, quality management system, etc.

Read through the case study to know how Freyr managed to deliver high quality audit review documents as per the latest Regulatory standards of the USFDA, within two weeks.

The client was one of the top UK based pharmaceuticals company. The client was looking to partner with a Regulatory expert to carry out the Good Manufacturing Practices (GMP) audit for one of its sites. Freyr assisted the client by streamlining its audit functions, procedures and documentations. The Regulatory expert also supported the client by compiling and finalizing the audit agenda to complete the audit under stipulated timelines.

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The client is a Switzerland based top pharmaceutical manufacturing company. The client approached Freyr with an intention to perform audit for its Active Pharmaceutical Ingredient (API) suppliers. Freyr assisted the client with audit for two of its API suppliers’ manufacturing facilities and procedures. The major challenge faced by the client was to understand and decode the current Good Manufacturing Process (cGMP) requirements as per the Swiss Medic.

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A USA based leading pharmaceuticals company was looking for a Regulatory partner to carry out audits for its Active Pharmaceutical Ingredient (API) supplier and formulation supplier. Freyr provided Regulatory support to the client by gathering all the necessary information about both the facilities and conducting audits within two days.

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One of the Spain-based leading innovator in medical aesthetics technology approached Freyr for Regulatory support with mock audit for their Quality Management Systems (QMS) to ensure compliance with Stage II MDSAP requirements. En-route, the client faced multiple challenges like, transfer of certain manufacturing operations to a new site, yearly surveillance scheduled round-the-corner, travel restrictions due to Covid-19 pandemic, multi-site manufacturing operations, etc.

A UK based leading software services company approached Freyr for Regulatory assistance with Quality Assurance (QA) consultation. The client was looking for assistance with the implementation of internal Quality Management System (QMS) and closure of Corrective Actions and Preventive Actions (CAPA). Freyr assisted the client by collating all the necessary information and providing documentation support.

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The client is a UK based software services company who was looking for Regulatory support with Quality Management System (QMS) and ISMS remediation. Freyr assisted the client with establishing SOPs for QMS/ISMS documents along with establishing various documents. The major challenge faced by the client was creating 60 SOPs and their related templates to align with the business procedures of the client.

To know how Freyr managed to create 60 SOPs for QMS/ISMS remediation documents under strict timelines, download the case study.

An India based leading generic pharmaceuticals company approached Freyr for streamlining its pharmacovigilance process to include Company Core Data Sheet (CCDS). The major challenge faced by the client was lack of an existing process to maintain CCDS. Freyr supported the client by establishing processes for maintaining CCDS as per the concerned health authority guidelines.

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