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      The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.

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      Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.

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      Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

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Regulatory Software & Services

 

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  • SPL and SPM Software & Ideal Features for Consideration

    SPL and SPM Software & Ideal Features for Consideration

    November 18, 2020 Regulatory Affairs, Publishing & Submissions, Regulatory Software & Services

    Structured Product Labeling (SPL) and Structure Product Monograph (SPM) are the mandatory document mark-up standards for the submission of label content, product and facility information and any subsequent changes to the existing label information in an electronic format.

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  • 4 Key Factors to Select a Submission Software

    4 Key Factors to Select a Submission Software

    November 28, 2019 Regulatory Software & Services, Regulatory Affairs, Publishing & Submissions

    Drug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety and efficacy of their drugs in the form of Regulatory submissions. These submissions are intended to report how drug companies manufacture their drugs, design clinical trials, report safety findings, and create promotional material.

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  • Life Sciences Regulations 2018

    Throwback 2018 – The Regulatory Summary in a Nutshell

    December 27, 2018 Regulatory Artwork Services, Food and Food Supplements, Compliance, Audit and Validation, Consumer Healthcare, Cosmetics Regulatory Services, Medical Devices, Pharmaceutical, Registration Strategy, Regulatory Intelligence, Regulatory Labeling, Regulatory Software & Services, Regulatory Affairs, Market Access, Regulatory Consulting, Publishing & Submissions, Regulatory Medical Writing, Health Authority Updates

    The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.

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  • ISO In Revision of IDMP Standards

    ISO In Revision of IDMP Standards – What Should You Know?

    November 16, 2017 Regulatory Software & Services

    As popularly known, IDMP (Identification of Medicinal Products) can be defined as a set of common global standards and technical specifications of data elements, formats and terminologies that enable unique identification and exchange of medicinal information.

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  • TGA Label Changes & Updates

    TGA Label Changes. Decode the Updates.

    August 1, 2017 Regulatory Labeling, Regulatory Software & Services

    It’s been almost a year since we’ve reported that Therapeutic Goods Administration (TGA) is on its way to impose new labeling requirements.

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  • eCTD Submission Solutions for Multiple Geographies

    The Ultimate Solution for eCTD Submissions in Multiple Geographies

    July 19, 2016 Pharmaceutical, Publishing & Submissions, Regulatory Software & Services, Regulatory Consulting

    Identify the best suited software ahead of time

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  • 3 FDA's Guidance for Individual Patient Expanded Access

    3 FDA’s Final Guidance Docs for Individual Patient Expanded Access – What should you know?

    June 16, 2016 Regulatory Software & Services, Health Authority Updates

    Times when patients are going through serious / immediately life-threatening conditions and physicians are left with no options except to opt for the investigational treatments, navigating certain processes would be challenging and time-consuming.

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  • IDMP Implementation & Solution

    Methodologies Effecting the IDMP Implementation: Pick the Right Solution

    June 14, 2016 Regulatory Intelligence, Regulatory Software & Services, Regulatory Consulting, Health Authority Updates

    IDMP has continued to be a hot topic in the pharma regulatory industry lately. It was expected that, in less than a month, EMA (European Medicines Agency)  would want companies to start utilizing the defined terminologies to be submitted from July 1st2016. However, this has been further delayed according to the other industry sources.

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  • Redaction in Regulatory Documents

    Redaction in Regulatory Documents: Fundamentals 101

    May 26, 2016 Regulatory Software & Services, Health Authority Updates

    In a general scenario, it is important to share the clinical trial analysis to increase the scope of further research and transparency in the flow of information. However, there are different levels of information that needs to be distributed to the public.

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  • Guidelines for EVMPD & XEVMPD Challenges for XEVMPD Submissions

    XEVMPD: How a Partner Helps Efficiently Navigate the Submissions Landscape

    May 10, 2014 Pharmaceutical, Regulatory Intelligence, Regulatory Software & Services, Health Authority Updates

    The EudraVigilance Medicinal Product Dictionary (EVMPD) has undergone several changes and enhancements since its inception in the year 2005 until now.  EVMPD has been revised and is now known as XEVMPD with enhancements that include increase in the data to be captured, revised controlled vocabulary and submission criteria.

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