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 China-based nuclear medicine manufacturer and diagnostic products and services provider looking for Regulatory support in submitting variations for their existing products in the eCTD format. There were several challenges in working with global teams virtually to offer continued support and validate the previously submitted sequences by another vendor. With in-depth knowledge in the global Regulatory specifications, Freyr's team imported the previous sequences and created an ongoing lifecycle maintenance submissions system.

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.

The Client is a leading Health care company based out of India. The client approached Freyr to implement Regulatory Information Management System (RIMS) to support the creation of records for products, registrations and to track status of HA submissions and HA interactions. Freyr assisted the client with the required support through Freyr SPAR, our future-ready software platform built based on IDMP ISO standards.

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The client, a top US-based cosmetics company, approached Freyr to perform audit representation and consultancy services for the products that were already notified and placed in the Malaysian market by the distributor. One of the major challenges was the discrepancy between the information in the portal regarding the formulation and the actual formulation that was present in the PIF. However, Freyr diligently provided the required services to the client, helping them to pass the Health Authority audit without any major nonconformities.

An India-based leading consumer goods company approached Freyr for support in the product compliance check involving a thorough review of formulation, label and claims for their products. Freyr performed a thorough review of the same as per the Malaysian cosmetic regulations and suggested the required changes.

Decode how Freyr assisted an India-based leading consumer goods company by providing necessary compliance checks for their hair care cosmetics in Malaysia. Download now!

A Russia based leading oral care products manufacturing company approached Freyr for claims assessment for their oral care products and the project primarily focused on checking the acceptable and unacceptable claims as per the Malaysian cosmetic regulations. Freyr conducted a complete label review to analyze if the product claims are compliant and suggested necessary corrections in the claims to adhere/align them with the Malaysian labeling rules.

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The client, an India-based leading manufacturer and exporter of natural hair color products, approached Freyr to seek the complete method of analysis in article-09 of ACD to check the insolubility parameters. Freyr came up with a comprehensive Regulatory report that described methods to determine water solubility.

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