• “During the past several years, I’ve had the pleasure of working with Freyr Solutions in the publication, validation and electronic submission of regulatory documentation to the US FDA. The Freyr team had provided excellent professional service. The staff is knowledgeable, responsive, and offers fast turn-around and accurate e-publication services at a reasonable cost. I have no hesitation in recommending them to my clients.”

    - President
    Leading regulatory and quality consulting company

  • “We are excited about completing the filing of BLA. We would like to send Freyr team, a gift of gratitude for the late hour’s work”

    - Head, Global Regulatory Affairs
    US based biotechnology company

  • Dear Freyr Team,
    You are truly awesome. I make that <60 mins response time is marvelous. Thankyou everyone! Indeed, that was a fabulous job for the team.”

    - UK Regulatory Operations Lead
    A Leading Pharmaceutical CDMO for APIs and finished dosage forms

  • “This is fantastic news! Thank you Freyr for your extraordinary efforts to complete this major milestone on time.
    Congratulations to the Core Team for your contributions to this achievement. The information that you generated through the development process and your assistance in pulling it together for this submission was amazing! It was very satisfying to read through the -2500-page document! ”

    - Project Head, Vision Care Development
    Leading global eye care company

  • “We have accomplished one more major filing of PMA submission for devices on time. This submission US PMA (22nd April 2016) is one of our Milestones targeted for this year. Special note to mention that published output for this submission includes Paper Copy (-2500 pages) and eCOPY (150 document) which was independently handled by Freyr resource without any quality issues. Thank you for the outstanding work and quick turnaround to get it published on time which enabled project team to achieve the milestone. Keep up the good work going.”

    - Global Franchise Head – Submissions
    Switzerland based, Global Pharmaceutical Company

  • “Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the type IV.”

    - Senior Research Assistant
    US based leading biopharmaceutical company

  • “The Global Clinical Trial Application packages are now final (5 days prior to the agreed upon target dispatch of Sept 27) and have been dispatched to the CTLs and HUB (and out of HUB countries) to facilitate local health authorities and ethics committee submissions.
    We would like to take the opportunity to thank Freyr for valuable contributions towards this CTA package under the stretched timelines of this RACE program.
    We remain available for support with local HA submissions and queries to enable a successful FPFV.”

    Regulatory Lead – CTA (Clinical trials application)
    Switzerland based, Global Pharmaceutical Company

  • “Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified by the GRA Lead. This continuously demonstrates Freyr's commitment towards our company’s milestones, keeping the patient in mind.”

    - Director
    Global Regulatory Affairs - Operations
    India based, Global top 5 Generic Pharma Company

  • 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

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