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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.
In a recent development, the US FDA has released a new guideline to assist the microneedling device manufacturers understand the product classification, applicable regulations, registration pathways and data requirements.
Microneedles are an array of blunt or sharp micro-protrusion pins, tips or needles of varying lengths. These products may be used by...
Many countries are adopting, ban on animal testing, globally. Walking the same path, Brazil too has taken early steps towards the cause, but with many changes all through. From the advent of Arouca Law in 2008, which contributed to the promotion of innovative non-animal methods and the Three R’s (Replacement, Reduction and Refinement), Brazil has now come to a stage, where specific legislation...
Starting early 2020, due to the outbreak of COVID-19, it is observed that the demand and prices for soaps across the supply channels (at supermarkets, convenience stores, hyper markets, wholesalers, drugstores and pharmacies) have increased by a noticeable margin. Liquid based products, sold in hyper markets networks have gone up by almost 5 to 6 percent (%), whereas, on the other hand the...
Nowadays, cosmetic products have become a basic necessity for consumers across the world. Consumers, in turn, have their own set of concerns and limitations regarding what they want to use on their skin. And, it is needless to say that the industry is taking steps towards addressing these concerns and making it clear to use safe and effective cosmetic ingredients in their products. While a lot...
Medical devices are evolving and embracing the technologies, so are the Regulatory pathways to govern them. To add to the same, the Brazilian national Health Authority – ANVISA, has published a guidance dedicated to the software with the intended medical purpose (Software as Medical Device – SaMD). The new guidance is aimed at preventing or mitigating the risks associated with the use of...
It is well known that the risk of a chemical, majorly depends on the inherent toxicity of the chemical and the extent of exposure. In chemical management, determining the toxicity of chemicals is necessary to understand its potential to cause adverse effects when an organism, population or system is exposed to that specific chemical/agent.
Across the globe, Regulatory decisions for...
The Center for Drug Evaluation and Research (CDER) has recently launched two (2) quality management pilot programs for Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). The purpose of the pilot programs is to gain insight from the third-party assessments of the manufacturer’s quality management system (QMS) and enhance the future...
Brazil’s National Agency of Health Surveillance (ANVISA) published a new Resolution of the Collegiate Board of Directors (RDC No. 423/2020). The new resolution declared the elimination of the Cadastro registration pathway for Class II medical devices and IVDs and substituted the same with a notification registration pathway (Notificação). The main goal of this new resolution is to further...
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. SPL format defines the structure and content of label information as per the United States Food and Drug Administration (US...
It is well known that COVID-19 has pushed many organizations to drive their auditors and the compliance teams adopt the right technology to perform remote audits. While remote audit techniques are similar to those of traditional audits, they leverage electronic means to obtain audit evidence for evaluations. The way or the procedure for remote audits depends on the business function and the...
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