• FDA’s New COVID-19 SPL Templates & Pre-requisites

    The COVID-19 pandemic has disrupted all the industries across the world. To handle the situation carefully, certain proactive measures have already been rolled out. One among them is to properly sanitize the hands with over the counter available drugs such as Hand rubs and Hand Sanitizers. To make such products adequately available in the market, the United States Food and Drugs Administration...

  • EMA Prefers Electronic Certificate Provision Over Printed Copies
    May 4, 2020 Regulatory Affairs

    With the prevailing COVID-19 pandemic, the Regulatory bodies are propelled to take quick and flexible Regulatory actions. Accordingly, EMA has called for a new system of issuing electronic certificates for human and veterinary medicines. Proposedly, the Agency will no longer provide printed certificates, but only the electronically signed and authenticated certificates. The EMA’s certification...

  • Immunity Boosting Supplements & The Need of Quick Market Entry

    With the number of ailments and stress levels rising in the current scenario, people are willing to instantly boost their immunity levels. But for most, the regular diet is far from building up the necessary. While most of us are able to get our nutrients from a healthy diet, many are still struggling to manage a well-balanced or planned diet and that is causing the rise of vitamin...

  • CDSCO Fast Tracks Regulatory Approvals For COVID-19 IVD Kits

    Ever since the World Health Organization (WHO) has declared the COVID-19 outbreak as a pandemic, the global health authorities and life sciences organizations are quickly responding to the situation to see how they can make meaningful contributions.

    Given the significance of ‘Testing’ in these extraordinary times and to align with the increasing demand for more COVID-19 diagnostic kits...

  • FDAs Expedite Regulatory Pathways for Medical Emergencies
    April 7, 2020 Regulatory Affairs

    While the world is tussling with COVID-19 pandemic, there’s an emergency need for its treatments and vaccines. Though, currently, there is no FDA approved therapy or vaccine for COVID-19, the agency has several tools to expedite the review and approval of a COVID-19 biologic treatment or vaccine, after it emerges.  

    FDAs Tools

    The rising concerns of COVID-19 outbreak,...

  • Managing Label Compliance in a Highly Complex Supply Chain

    The pharmaceutical supply chains are highly complex, with multiple stakeholders like manufacturers, suppliers, technology providers, packaging partners, and retailers obliged to maintain the Regulatory standards for quality, safety, and procedural accuracy throughout the product lifecycle. As each product moves down the supply chain, stakeholders involved at every level of the product...

  • Mandatory Submissions through CESP in Cyprus - Key Considerations

    Being a Member State of the European Union (EU), the Republic of Cyprus through the Department of Pharmaceutical Services has mandated the submission of the medicinal products for human use through the Common European Submission Platform (CESP).

    The CESP is an initiative available for all the EU Member States, authorization applicants and holders, and for both human and veterinary...

  • CDSCO Amends the Medial Device Rule 2017
    February 28, 2020 Medical Devices

    To strengthen the regulations of medical devices in India, the Central Drugs Standard Control Organization (CDSCO) has released two final amendments to the Medical Device Rule 2017. The amendments are expected to provide more clarity on the scope of medical devices and establish an expedited registration route for certain devices. The CDSCO has announced that both the amendments will come into...

  • EU MDR and its Impact on Device Labeling and Artwork

    To ensure high standards of quality and safety for medical devices being produced or supplied, the European Union (EU) has released a new Medical Device Regulation (MDR) in May 2017. As the transition period for medical device manufacturers will come to an end from May 26th, 2021, organizations must relook at implementing compliant processes and procedures accordingly.

    For...

  • Post-Brexit Updates for Pharma and Device Manufacturers
    February 27, 2020 Medical Devices, Pharmaceutical

    On January 31, 2020, the United Kingdom (UK) officially left the European Union (EU) making the Brexit come alive. In the light of Brexit, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have released certain Regulatory guidelines to ensure both pharmaceutical and medical device manufacturers are ready for the transition period. Here are...

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