The client was a leading Indian pharmaceutical manufacturer looking for Regulatory support in filing DMF submissions with 100% accuracy. There were several challenges in the project such as maintaining the lifecycles of multiple products and strict timelines. Freyr identified the need for tracking versions of frequently changed documents and filing them in the eCTD format. Freyr deployed several full-time employees to offer continual support and filed the submissions to the CDSCO for the DMF requests.

The client is an India-based pharmaceutical company manufacturing medicines, injections, and health products, aiming to market them in Singapore. The client wants to manage the Regulatory Information Management System (RIMS) and approached Freyr to reduce the application’s complexity. Freyr assisted the client by implementing Freyr SPAR – System for Products and Registration, to improve RIMS, automate updates, and format the data structure.

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The client was a USA-based leading pharmaceutical company looking for Regulatory support in making IND submissions to the CDSCO. There were several challenges, such as tracking versions of frequently changed documents, high volume of review documents, and stringent timelines. Freyr was able to accomplish granular document level publishing and a detailed tracking system in addition to high-quality submissions. A team of publishing experts validated the source documents using appropriate tools, thus resulting in zero errors and warnings.  

The client was a USA-based leading pharmaceutical company looking for support in IND submissions and amendments in existing documents. The project presented with end-to-end publishing activities which had to be completed in a short period. Freyr offered granular document level publishing services, including the review of source documents, and was able to make the IND submissions and document amendments on time. With zero errors and no warnings from the CDSCO, Freyr made it a successful collaboration in every aspect.

The client was a Hungarian research and development pharmaceutical company and was looking for Regulatory support in the filing of response and making amendments to the original submissions made to the USFDA and Health Canada. The project came with several challenges like tracking versions of frequently changed documents and stringent timelines. Freyr validated the documents and helped in granular Document Level Publishing (DLP). The experienced resources at Freyr were able to create a tracker that helped the client in the LCM activities.

An India-based API’s manufacturing company wanted to calculate the Health-Based Exposure Limits (PDE/OEL reports) and required cleaning validation support to meet the GMP requirements. The client approached Freyr for medical writing services and required database tools to meet the Regulatory compliance, Board Certified Toxicologists (DABT) and European Certified Toxicologists (ERT). It was challenging to prepare and align the multiple report templates with the current Regulatory requirements, as there was limited data to access the safety.

A fully integrated biopharmaceutical company was aiming to calculate the Health Based Exposure Limits (PDE/OEL reports) and required cleaning validation support to meet the GMP requirements. The client approached Freyr for medical writing services and had in-house database tools to meet the Regulatory compliance, Board Certified Toxicologists and European Registered Toxicologists (ERT). It was challenging to prepare and align the multiple report templates with the current Regulatory requirements, as there was limited data to access the safety.  

An India-based fastest growing pharma company was aiming to prepare PDE/OEL reports and approached Freyr for medical writing services. The client required database tools to meet the Regulatory compliance, Board Certified Toxicologists (DABT) and European Registered Toxicologists (ERT). It was challenging to prepare and align the multiple report templates with the current Regulatory requirements, as there was limited data to access the safety.