• Turkey Cosmetics Market potential

    The global cosmetics production is one of the fastest growing industry globally, with a market size of USD 532.43 billion (in 2017). It is one of the few industries which is not much affected by the ups and downs of the global economic conditions. Even though the overall sale of the products is affected, the industry manages to maintain a steady sales volume. If the market continues to grow...

  • Pharma 4.0. The Future of Pharmaceutical Manufacturing
    December 10, 2018 Pharmaceutical

    The advent of internet has fundamentally changed the course of action of almost every industry. Even though  internet has been around for a while, it wasn’t until the emergence of Industry 4.0 that the digital transformation started helping the industries to evolve. While industry 4.0 was expected to address the increased need of personalized products with the help of Internet of Things (...

  • 5 Common Compliance Challenges in Life Sciences Industry

    Life sciences industries are stepping ahead with new initiatives every day to align with the growing Regulatory restrictions put forth by the health authorities. But as the supervisory expectations of agencies are evolving at an increased pace, at times, organizations are finding it challenging to align with all of them on time. In this scenario, instead of implementing the updates whenever...

  • ANVISA Regulates Different Label Variations for the Same Product
    December 4, 2018 Regulatory Labeling

    The National Health Regulatory Agency (ANVISA) of Brazil, on 22 November 2018, published a new standard - Resolution RDC 250/2018 related to the Official Gazette of the Union. The new resolution, related to Cosmetics labeling, was passed to enhance the agility of the cosmetics sector in Brazil and reduce the cost of labeling processes to the organizations.

    In brief, at present, it is...

  • Regulatory Compliance Challenges,Modernize the Approach

    Quality and compliance are the building blocks of safety and efficacy of drugs and devices. They are the pathways for life science organizations to provide a meticulous framework to their businesses. According to a recent survey, over the years, the Regulatory scrutiny has increased across various aspects of the business including clinical operations, data privacy, and sales and marketing....

  • Clinical Evaluation Report challenges and Solution

    A Clinical Evaluation Report (CER) is a safety and performance assessment report of any medical device based on the clinical data related to it. The clinical data is either collected through clinical investigation or by availing previously collected data of a substantially equivalent device. To sell a medical device in Europe, it is compulsory for manufacturers to prepare an accurate CER to...

  • The Health Authority Face-Lift: China and South Africa

    As a big face lift, Health Authorities of China and South Africa have recently revealed their identifications. The China Food and Drug Administration (CFDA), has recently announced the change related to the agency’s official English name, the National Medical Product Administration (NMPA). Similarly, South Africa’s Medicines Control Council (MCC) has officially concluded that MCC has...

  • Global Regulatory and Market Strategies for Nutraceuticals Manufacturers

    Wide range of food products, dietary supplements and other health foods that are consumed to enhance the nutritional value of food are constantly growing, worldwide. All combined can generally be termed as nutraceuticals. Global consumers are viewing the nutraceutical products as potential alternatives to medicinal products owing to their preventive characteristics against some of the common...

  • Digital Labeling – The New Frontier in Life Sciences
    November 12, 2018 Regulatory Labeling

    Be it a drug, device, cosmetic or food product, it is essential to convey the product information with respect to its usage, indications, warnings and other crucial aspects that are informative and beneficial to the end-user. As we all know, the primary source to communicate this information is the label on the package of a product, and additional components such as leaflets and inserts...

  • Simplified Regulations for Children Cosmetics by ANVISA

    The Brazilian Association of personal hygiene, perfumery and cosmetics (ABIHPEC) announced a Regulatory revolution for the Brazilian cosmetics industry. The Health Surveillance Agency (ANVISA) has modified resolution RDC 07/2015 to simplify the regulations put on children products. The reformed resolution removes the obligation of registering the product before launching it into the market....

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