• WHO Guidelines on Regulatory Framework for Local Health Authorities
    July 27, 2021 Regulatory Affairs

    Regulatory practices across the globe have a significant role in ensuring that the drug preparation/product sourced for a disease is safe for consumption and effective against the targeted ailment. As of the current pandemic situation, Health authorities across the globe are granting emergency use authorizations based on the preliminary data obtained through phase III clinical trials. However...

  • 2021 Chemical Industry in India & Market Opportunities

    The chemical industry has played a pivotal role in boosting the Indian economy and providing livelihood to more than two (02) million people. As the Indian Government intends to transform India into a global manufacturing hub for chemicals, the industry is set to witness major positive shifts. India, indeed, has become a key investment destination for chemical manufacturers.

    Over the...

  • SFDA Guidance on Medical Devices Labeling Requirements
    July 27, 2021 Medical Devices

    Labeling has paramount importance in the medical device industry for ensuring high standards of quality and safety. The labels help educate the end-users or patients about how to use the device, who should use it, how to operate the device safely and what risks it could pose. Therefore, medical device manufacturers must gain a clear understanding and comply with the updated Health Authorities...

  • Manufacturing Site Registration for Medical Devices in Sri Lanka

    With the growing economy and population, the demand for safe and effective healthcare facilities has increased in Sri Lanka. National Medicines Regulatory Authority (NMRA) of Sri Lanka is responsible for assuring that the medical devices imported into Sri Lanka pertain to high standards of safety, quality and efficacy. For the same reason, NMRA has efficiently crafted the Regulatory approval...

  • Achieving Fair Balance of Ad Promo Information

    Brand communication is about conveying why a particular brand is a smarter option than the competitors in the marketplace. The Pharma industry is no oblivious to the same. Across the globe, due to the highly fragmented market space, communication becomes the whole and sole prospect to architecture any brand identity.

    When we talk about advertisements for Over-the-counter (OTC) products...

  • The New Normal of Pharmaceutical Ad Promo Material

    In an era of Type-Backspace-Enter, relying on the Ink-Paper-Print model especially amidst the global pandemic can be worrisome. Traditional brand communication becomes a difficult affair due to social distancing measures and hence, the society is adapting to the ‘New normal’. Brands across the globe have already adopted changing trends in communication aligning with various pandemic norms....

  • Effective Regulatory Strategies for Medical Devices Registration
    July 16, 2021 Medical Devices

    Bringing novel medical devices into global markets can be a daunting process for device manufacturers. As the medical device industry is highly regulated, manufacturers find it excruciating to align with the target market’s registration requirements. How to navigate the Regulatory maze of global registration requirements? Effective planning and early considerations for medical device...

  • Regulation for Disinfectants in the US

    Most of us have come across the terms 'Disinfectants' and 'Sanitizers' during COVID-19. Both the products fall under antimicrobial pesticides. While disinfectants and sanitizers are commonly referred as same, the major difference between them is that the disinfectants kill the microbes, bacteria and virus on the surface whereas the sanitizers reduce their numbers.

    The US Food and Drug...

  • Food and Dietary Supplements in Australia and New Zealand

    A growing business is directly proportional to the potentiality of the market. And when it comes to the food and dietary supplement market, the innovation and creativity of the product depends upon the manufacturers and sometimes in special circumstances, like the pandemic to make the products more desirable for the consumers, brand owners try to recreate the products in different product...

  • EU CLP Regulation: Requirements for Labeling and Packaging

    The chemicals industry plays a pivotal role in producing petrochemicals, polymers, basic inorganics, specialities and consumer chemicals in Europe. European Chemicals Agency (ECHA) implements the EU’s chemicals legislation to protect health, safety and the environment. Classification, Labeling and Packaging (CLP) regulation helps in identifying hazardous chemicals and informs users throughout...

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