While creating compliant packaging, controlling the labeling flow and its implementation through artwork, supply chain and printing involves several internal and external stakeholders. Following up with all the teams to meet the time-critical mandates and deadlines can be challenging.
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September 16, 2021 Publishing & Submissions, Regulatory Software & ServicesAs many of the Health Authorities transitioned from paper documentation format to the eCTD format, it is time for organizations to define key measures to submit documents in the electronic format to remain compliant.
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May 7, 2021 Publishing & Submissions, Regulatory Software & ServicesOn-time Regulatory submission is the key to achieve quick time-to-market. But, with a lack of planning, the industry could face a lot of complications which may result in rejected submissions, delayed market-entry, increased costs due to extended timelines.
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As we all know, each country has its own set of cosmetic regulations that manufacturers must adhere to. Many countries have banned several ingredients, while some substances are restricted to a maximum concentration, which makes it difficult for the product manufacturers to market in different countries.
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March 18, 2021 Chemicals, Regulatory Affairs, Regulatory Software & ServicesUnder the Classification, Labeling and Packaging of substances and mixtures (CLP) regulation, Chemical companies, who wish to place hazardous chemical mixtures such as paints, coatings, detergents, solvents, etc. in the European market are required to provide notifications of the hazards in their products.
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November 18, 2020 Regulatory Affairs, Publishing & Submissions, Regulatory Software & ServicesStructured 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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November 28, 2019 Regulatory Software & Services, Regulatory Affairs, Publishing & SubmissionsDrug 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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December 27, 2018 Regulatory Artwork Services, Food and Food Supplements, Compliance, Audit and Validation, Consumer Healthcare, Cosmetics Regulatory Services, Medical Devices, Pharmaceuticals, Registration Strategy, Regulatory Intelligence, Regulatory Labeling, Regulatory Software & Services, Regulatory Affairs, Market Access, Regulatory Consulting, Publishing & Submissions, Regulatory Medical Writing, Health Authority UpdatesThe 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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November 16, 2017 Regulatory Software & ServicesAs 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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August 1, 2017 Regulatory Labeling, Regulatory Software & ServicesIt’s been almost a year since we’ve reported that Therapeutic Goods Administration (TGA) is on its way to impose new labeling requirements.