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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.
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.
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.
When the COVID-19 pandemic was first recognized as a global health crisis in 2020, global Health Authorities (HAs) took innovative steps to deal with it in the best possible manner. Likewise, pharmaceutical companies came up with several vaccines/medicinal products for the benefit of the public. However, registering the products turned out to be quite challenging.
Emergency Use Authorizations (EUAs) are significant in making life-saving medicinal products available to patients faster. They have been helpful in dealing with pandemics like COVID-19.
To note, there are many gaps in the Regulatory science that need to be addressed for the development and evaluation of medicine. Global Regulatory Agencies make strong efforts to close these gaps and enable access to innovative medicines that address the patient’s needs.
Intending to curb the spread of COVID-19, the MHRA extended the free PPE (Personal Protective Equipment) scheme, which was initially introduced in March 2020. The scheme intends to protect the health and social care providers, and community pharmacies, and public sector organizations from COVID-19, by providing easy access to PPE in the volume required.
Biologicals are booming as therapy and have significantly become an established treatment option to provide ailment to niche disease segments which seemed impossible earlier. COVID-19 pandemic has made researchers keen to develop biosimilar and interchangeable products for the patient population at an affordable price.
Modern-day research and advancements have changed the dynamics of the life sciences landscape. Governments & Health Authorities are constantly facing new challenges amidst the paradigm shift from the pre-COVID era to the present-day scenario. Such a challenging environment brought about an end-to-end evolution of the industry, from new drug development to supply chain management.
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.
Health Canada has clarified its stand on the research use only testing kits related to COVID-19. Health Canada regulates the import and sale of medical devices and IVDs (In-vitro Diagnostic Devices) in the Canadian market.
Since the onset of Coronavirus Disease 2019 (COVID-19), Health and Human Services (HHS) has declared a Public Health Emergency. The US FDA, since then, has been releasing various enforcement policies to ensure continued supply of certain essential medical devices, which play a vital role in prevention, diagnosis, management and treatment of COVID-19 and associated co-morbidities.
Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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