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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.
Over the decades, advancements in treatment procedures have brought about necessary amendments to the Regulatory framework.
After nearly two (02) decades of issuing the first draft guidance, the United States Food and Drug Administration (US FDA) finalized the guidance on population Pharmacokinetics (PK) in February 2022. The latest draft explains the application of population PK in drug development and recommendations on therapeutic individualization.
Marketing Authorization Holders (MAHs) in the United Kingdom were provided and asked to submit any/all data and related information for all converted licenses in the electronic Common Technical Document (eCTD) format within just one (01) year starting from January 01, 2021.
Structured Product Labeling (SPL) and Structure Product Monograph (SPM) are the mandatory document mark-up standards for the submission of label content, product and facility information and any subsequent changes to the existing label information in an electronic format.
For the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for Type III Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format.
We hope you have taken necessary inputs on Health Canada (HC) eCTD format and its content structure from our previous write up.
The health authority of Canadian landscape, Health Canada (HC) has revised the submission requirements and mandated submissions to be in electronic format for certain filings post January 1st, 2018.
With the FDA concluded its mandatory first phase electronic submissions deadline, first question drug manufacturers could ask themselves is what’s next in line? Where else they can submit their data and which format they should get adopted to? With their target focused on global markets, we suggest to take one-at-a-time approach.
Ever since the electronic submissions initiated, there are growing instances that both health authorities and drug manufacturers are being benefitted.
Life Sciences, as an industry is rapidly evolving, so does the Regulatory requirements to sustain in the industry.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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