An established haircare provider, for their product categories like shampoo and conditioners, was looking for a Cosmetic Products Safety Report for the Europe region. The critical aspect for Freyr while assisting the client was huge list of ingredients, some of which have no safety data.
Decode this case to learn more on how Freyr offered successful safety assessment service following extensive reviews.
A US-based top 4, Biotech company, for its oncology, immunology and hormone replacement products, reached out to Freyr for regional labeling operations and process improvement. As part of the project Freyr initially had to face various criticalities such as lack of existing work instructions and wide variety of processes or guidelines across geographies.
Read this case to know more on how Freyr offered the client a host of Regulatory labeling services that proved to be beneficial.
I wish to place on record my sincere appreciation for getting us to this point with the CTD update for our product. Your diligence, thorough input and timely delivery of all requests have been noted and is greatly appreciated.
- Regulatory Manager
Global Top 5, Pharma & Consumer Healthcare Company
Thanks for your extreme support during submission. It’s my pleasure to work with you. Without your hard work and dedication to work I guess we could unable to complete the task on time. Best of luck for your future projects and appreciate your efforts!!!!
- Manager-Regulatory Affairs
US based, Global, Pharma Company
overall it was great experience working with Freyr’s team and we were quite happy with the feedback the team has shared.
- GM (General Manager)- Global Clinical Development
An India-based Pharmaceutical and Biotechnology company
Congratulation!!! Thanks for great Support for successful ANDA filing. Especially for publishing team heartfully appreciate their last hours’ hard work.
- Assistant Manager
A Privately Held Pharmaceutical Research and Development Company
We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and also how we operate, it is possible to realise our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team!
I am very satisfied with Freyr's credibility in my interactions. I received good advice that I felt was very above board. We had previously employed a consulting group that specialized in policy strategy and found that Freyr was able to accommodate those needs but also get to the practical needs of preparing and filing our application with the FDA. This was very important to me, and means that I will use Freyr's services in the future.
Wanted to share the good news that our BLA was accepted for filing by the FDA. We appreciate all of Freyr’s hard work that went into making this submission ACCEPTABLE!!
- Head, Global Regulatory Affairs
US based biotechnology company
We have had a good impression of Freyr and feel more than comfortable telling partners that we are engaging with Freyr for our Regulatory needs. The project went very smoothly and we felt went along at a reasonable pace. The team was knowledgeable, friendly and accommodating. Rapid response appreciated. Keep up the good work.
- Director, Regulatory Affairs
US based a leading precision medicine company