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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.
With an increasing number of new drug applications and clinical studies conducted to substantiate the efficacy and safety of new molecules, it becomes critical for pharmaceutical organizations to disseminate scientific information to the target audience via publication in a renowned scientific journal.
Communication through digital media vastly influences the perception of consumers regarding a product/service. Hence, pharmaceutical firms are constantly evolving to achieve a fair balance while advertising their products.
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.
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.
Regulatory writing discipline with its guidelines and regulations is considered complex. In addition, staying ahead of an ever-changing Regulatory environment for generic submissions and approvals is a tedious process.
Profound research with poor documentation may not achieve Regulatory approvals. Documenting each section of ANDA demands attentive preparations by medical writers, else the entire development and marketing strategy will be derailed. Besides research protocols, the regulations, restrictions, and legalities that govern scientific and medical information play a vital role in ANDA submissions.
Clinical and nonclinical research programs demand the development of high-quality documents for timely submissions and approval of the drug product from Regulatory authorities. Medical writing plays a crucial role in drafting all the necessary documents right from drug development through submission and approval.
With an aim to make anonymized clinical information in drug submissions and medical devices applications publicly accessible, Health Canada released a guidance document named as Health Canada's Public Release of Clinical Information (PRCI).
While researching for an innovative drug/device/cosmetic/food supplement, a huge amount of clinical data is expected to be generated. The conclusions of such data must be clearly reported with an appropriate level of detail to the health authorities (HAs). The information to be reported or documented might be research data, trial descriptions, findings, warnings etc.
The 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.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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