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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.
The pharmaceutical supply chains are highly complex, with multiple stakeholders like manufacturers, suppliers, technology providers, packaging partners, and retailers obliged to maintain the Regulatory standards for quality, safety, and procedural accuracy throughout the product lifecycle. As each product moves down the supply chain, stakeholders involved at every level of the product...
Being a Member State of the European Union (EU), the Republic of Cyprus through the Department of Pharmaceutical Services has mandated the submission of the medicinal products for human use through the Common European Submission Platform (CESP).
The CESP is an initiative available for all the EU Member States, authorization applicants and holders, and for both human and veterinary...
To strengthen the regulations of medical devices in India, the Central Drugs Standard Control Organization (CDSCO) has released two final amendments to the Medical Device Rule 2017. The amendments are expected to provide more clarity on the scope of medical devices and establish an expedited registration route for certain devices. The CDSCO has announced that both the amendments will come into...
To ensure high standards of quality and safety for medical devices being produced or supplied, the European Union (EU) has released a new Medical Device Regulation (MDR) in May 2017. As the three-year transition period for medical device manufacturers will come to an end from May 26th, 2020, organizations must relook at implementing compliant processes and procedures accordingly....
On January 31, 2020, the United Kingdom (UK) officially left the European Union (EU) making the Brexit come alive. In the light of Brexit, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have released certain Regulatory guidelines to ensure both pharmaceutical and medical device manufacturers are ready for the transition period. Here are...
It is evident that the labeling requirements in the European Union (EU) are quite dissimilar, given various region-specific regulations across the 27 member states. Besides this, the emerging European Regulatory landscape demands life sciences manufacturers to be more cautious in implementing and showcasing the safety information.
In the status-quo, to sail through the European market...
On August 3, 2017, the committee of the Eurasian Economic Union (EAEU) published the standards for electronic submissions of drug applications. With respect to same, the Board of the Eurasian Economic Union released two important ‘Decisions’ on the electronic submission format, which mandates the applicants to provide more detailed information. What are these ‘Decisions’ and guidelines related...
To strengthen the cosmetic product regulations in South Korea, the Ministry of Food and Drug Safety (MFDS) introduced six draft amendments in 2019. The amendments focus on various Regulatory aspects of cosmetic products such as manufacturing, scrutiny, labeling etc. The purpose of proposing these amendments is to ensure the distribution of safe and effective cosmetic products in South Korea...
Brexit is just around the corner and the United Kingdom (UK) is all set to leave the European Union (EU). The implementation date of Brexit was yet again postponed to January 31, 2020, after the UK requested more time for preparations. However, if the UK and the EU are able to ratify a withdrawal agreement by the time of Brexit, the UK will have a transition period until December 31, 2020, to...
Thanks to the evolving global Regulatory landscape! Each country now has its own, defined regulations and requirements in governing the quality, safety, and efficacy of the medicinal products entering or being manufactured in their market. In this scenario, it is necessary for organizations to know about specific Regulatory requirements of their targeted markets. If their targeted market is EU...
North America
South America
East Europe
Europe
North Africa & Middle East
Southern Africa
APAC
Australia & New Zealand
Japan & South Korea
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