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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.
During the COVID-19 pandemic, Real-World Data (RWD) and Real-World Evidence (RWE) were essential sources of information for the United States Food and Drug Administration (USFDA) to expedite the approvals of COVID-19 vaccines and therapeutics and to allow other clinical studies to progress under the changing circumstances.
Advance Therapy Medicinal Products (ATMPs) are novel drugs that meet patients’ specific needs. But they drastically increase the cost of treatment. Generic alternatives provide relief in terms of treatment cost with a quality drug of similar effectiveness.
In 2023, about fifty-one (51) drugs will get off-patented in the United States, opening the gates for generic drugs to claim a share of the expected expired drugs. Tracking the expiration of these drugs will help assess business opportunities and refine market entry strategies.
Over the years, procedures for assembling and filing eCTD submissions have evolved tremendously. Non-adherence to the submission requirements may occur when documents are not relevant to fit seamlessly into the given eCTD format.
Most life sciences organizations find it difficult to streamline their Regulatory submissions process due to frequent changes in the submission guidelines. According to a recent analysis conducted by the United States Food and Drug Administration (USFDA), 32% of submissions with study data had critical data conformance issues.
Pharmaceutical companies incur about 25% of drug development costs into the documentation. Strategic imperatives can help accelerate the drug development pipeline along with scrutiny of clinical and Regulatory content, enabling efficient reuse of more standardized content.
Over the past ten (10) years, the cost of bringing a drug into the market has increased by 140 percent. Globally, the top twenty (20) pharmaceutical organizations spend nearly sixty (60) billion dollars every year to bring a drug into the market and the average cost is estimated to be $2.6 billion, including drug failures.
Pharmaceutical advertising, including direct-to-consumer advertising, is regulated by the United States Food and Drug Administration’s (US FDA) Office of Prescription Drug Promotion (OPDP), Advertising and Promotional Labeling Branch (APLB) at the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) respectively.
For years, Regulatory publishing was done by manual tasks. Publishers used to work for hours formatting documents, generating Agency-compliant PDFs, performing quality checks, compiling documents for submissions, and troubleshooting issues related to submissions.
The ever-increasing demand for various channels to share information and engage with customers poses numerous challenges in the pharmaceutical industry. Such engagement comes with risks, particularly in the advertising domain. To ensure accurate and good practice, Health Canada regulates the advertising or promotional material before its dissemination in Canada.
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