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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.
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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.
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.
REALIZING IDMP COMPLIANCE DEADLINE BY JULY 2016: NO TRIVIAL UNDERTAKING
There are many questions on IDMP e.g; where is the data in an organization located? Is the cleanup and alignment of current data required? How do companies organize this data for easy retrieval and submission? Does the organization have processes that can benefit from a central repository?...
Artwork design is an essential process in the supply of a pharmaceutical product which basically ensures patient safety while reducing recall risk.
Artwork and labeling functions are an intrinsic part for the supply of a pharmaceutical product, and are under constant pressure to deliver an increasing number of projects in a compressed time frame. In the current business scenario,...
A Medical writer plays a prominent role in writing various non-clinical and clinical documents related to drug approval from health authorities, in order to bring it to the market for making them accessible to the customers. Medical writer needs to produce high quality documents in a short time. Client pharma companies deal with the production and testing of drugs, but presenting this...
Outsourcing has become an increasingly common practice in the Pharma and Biotech industry more so in the area of regulatory affairs and Pharmacovigilance. Regulatory outsourcing has now become a norm as most...
Cosmetic products have an estimated worth of €67bn in Europe, which is regarded as a massive enterprise. The primary requirement during the development of a cosmetic product is to ensure protection for the user’s health which is also the basis of the cosmetic legislation. This protection also enables increased consumer confidence in the brand.
COSMETIC LEGISLATION...
Pharmaceutical and medical device industries are constantly changing with developing supply chain themes and technological advancements due to which labeling must be looked upon with a new perspective. A host of latest trends have compelled Pharmaceutical and medical device industries to rethink, strategize and streamline processes, meet compliance norms and start and learn best practices....
Ever since the inherent risk in the marketing of medical devices and drugs increased, establishment of a tailor-made regulatory strategy for business success has been the call of the hour. The global environment has become pervasive because of the growing complexity in the pharmaceutical devices. Ultimately the regulation and market adoption of those avant...
Ever since the eCTD submission became mandatory by FDA in 2008, the life sciences industry has been facing certain difficulties in regulatory processes. Even though the electronic common technical document has been of great help in managing huge volumes of important documentation; there are a few glitches that complicate the submission process for the organizations....
It’s no strange for everyone who is into regulatory intelligence services that a well-proportioned regulatory strategy plays a key role in boosting the opportunity of regulatory approval. Now a regulatory plan is also equally important which helps in meeting the objectives of the ...
Today regulatory terms like eCTD, ASPPs, CANDA, SPL, MAA and NDA to name a few are the buzz words in the world of regulatory compliance. While each terminology indicates the inception of the cutting edge technology; they also come with some downright challenges for the life sciences companies. Just as in case with the regulatory submissions and publishing, if you too...
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