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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.
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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.
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.
When the COVID-19 pandemic was first recognized as a global health crisis in 2020, global Health Authorities (HAs) took innovative steps to deal with it in the best possible manner. Likewise, pharmaceutical companies came up with several vaccines/medicinal products for the benefit of the public. However, registering the products turned out to be quite challenging.
In the wake of COVID-19, deploying remote audit techniques is rising in the Life Sciences industry. With the imposed travel restrictions across the globe, medical devices, biotech, pharmaceuticals, and other life sciences organizations are turning towards virtual or Remote audits.
Do you know? One can save up to a million in the coming three (03) years by introducing Computer Software Assurance (CSA) in place of the existing Computer system validation (CSV) model!
Over the years, pharmaceutical organizations have incorporated CSV, a risk-based validation approach to ensure computer operating systems are at par with Regulatory requirements.
National Medicines Regulatory Authority (NMRA) of Sri Lanka has declared the ‘List of Countries’ to be exempted from the manufacturing site audits. Essentially, this list refers to the respective health authorities in the specified countries, also termed as ‘’Reference Countries.’’ The health authorities included in the list are:
You may know that the Medical Device Coordination Group (MDCG) has released a Q&A document related to previously released guideline - MDCG 2020-4: guidance on temporary and extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions.
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 devel
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.
As we all aware, COVID-19 pandemic resulted in the suspension of regular on-site inspections and as the world is slowly coming out of COVID-19 restrictions, Health Agencies are eying on resuming the on-site inspections.
To support manufacturers during COVID-19, the EMA has updated guidance on the Regulatory expectations for the medicinal products. A new section of temporary flexibilities is added to inputs on good manufacturing practices (GMP), and good distribution practices (GDP). The new development is aimed at responding to the increased demand for medicinal products amid COVID-19.
Post-Brexit, the biggest challenge for the pharmaceutical industry is its potential implication on Regulatory affairs. The derogation as a result of post-Brexit is expected to hit the pharmaceutical industry extremely hard, especially the Pharma companies operating in the UK.
North America
South America
East Europe
Europe
North Africa & Middle East
Southern Africa
APAC
Australia & New Zealand
Japan & South Korea
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