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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.
The post-pandemic world is realizing that the intersection of technology and a traditional way of doing business already exists with us. The highly competitive nature of our business only exemplifies the need of incorporating innovative technologies to augment and support customers in the ever-evolving Regulatory landscape.
Isn’t it interesting to see Artificial Intelligence (AI) sculpting out to have a thriving position in the Regulatory landscape? One of the most important reasons for this advancement is the ability of AI and Machine Learning (ML) applications to tackle everyday procedural challenges and logical issues that compliance officers put up with.
The changing landscape of the life sciences industry makes it necessary for the companies to adapt to the global Regulatory requirements, immediately. Companies need to evolve themselves for the necessary transition with each mandatory requirement from the health authorities.
Drug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety and efficacy of their drugs in the form of Regulatory submissions. These submissions are intended to report how drug companies manufacture their drugs, design clinical trials, report safety findings, and create promotional material.
Health Canada (HC) announced the revision of the validation rules for Regulatory transactions in electronic Common Technical Document (eCTD) format and published them as Version 4.4 on March 6, 2019.
Health Canada (HC) has one of the most stringent regulations for medical devices. To further increase the safety and effectiveness of devices, and optimize the health outcomes for end-users, the Canadian health authority (HA) is aiming to strengthen the current Regulatory framework. The three-part strategy announced recently as an action plan is the part of the same.
Artificial Intelligence (AI) is paving the way for innovative medicinal products and advanced medical devices. It is gradually headed towards decreasing repetitions in clinical trials, increasing the accuracy in drug designing processes and disease identification, personalization of patient diagnosis etc.
Although digitization and Internet of Things (IoT) have together enhanced the performance of medical devices, they have also made devices prone to cyber vulnerabilities. The malware and spyware invading the devices are growing. The hackers are mining for loopholes in devices and related software that allow them to corrupt the devices to compromise user data by malfunctioning the devices.
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.
Demand for cosmetics is consistently growing, worldwide. All thanks to the online product sale, increased beauty consciousness and younger generation’s lifestyle standards.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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