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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.
Clinical and nonclinical research programs demand the development of high-quality documents for timely submissions and approval of the drug product from Regulatory authorities. Medical writing plays a crucial role in drafting all the necessary documents right from drug development through submission and approval. When filing Investigational New Drug (IND)/ New Drug Applications (NDA) to the...
Due to the growing young population in the country, the cosmetics market of India is proven to be lucrative for manufacturers across the world. The continuous evolution of the industry is driven by the growing awareness of the consumers about their personal care needs, thus, fuelling the demand for local as well as internationally manufactured innovative products. This is leading to cosmetics...
Chemical mixture importers and downstream users in the EU are obliged to comply with Article 45 to the Classification, Labelling and Packaging (CLP) Regulation if their mixture bears physical or human health-hazardous classification. For products meant for professional and consumer use, Poison Centre Notification (PCN) must be followed from 1st Jan 2021, while for...
Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action. There had been delays in...
The US FDA continues to release and update the guidelines and enforcement policies for efficient management of the device Regulatory affairs in the USA, alongside handling the emergency health situation that surfaced due to the COVID-19 pandemic.
The Agency has revised the previously released Question and Answers document on, “Effects of the COVID-19 Public Health Emergency on Formal...
The MDCG (Medical Device Coordination Group) has released a position paper on UDI assignment to assist the manufacturers of spectacle lenses and ready readers about the obligations under the EU Medical Device Regulations (EU MDR) 2017/745. It also has the details to be considered while assigning an UDI (Unique Device Identification) to these devices. In addition, this position paper defines...
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 recent release throws further light on key considerations while adopting remote audit...
Building and managing an efficient Quality Management System (QMS) is a crucial step for medical device enterprises willing to deliver the right product to the customers. As almost all major markets across the globe made it a thumb rule to go by a compliant QMS while registering the products, it is indeed a primary requirement for manufacturers to maintain QMS for a successful product launch....
As the EU MDR transition deadline is inching closer, manufacturers must execute the labeling requirements with utmost priority and caution and must ensure high standards of quality, and safety for compliance. Prior to execution, understanding the new labeling requirements and accurate implementation is of paramount importance. Any labeling errors can impede the progress, cause product recalls...
Chemical products are used in a variety of sectors in the Life sciences industry. Pharmaceuticals and cosmetics sectors are a few among them. And the demand for Chemicals too has significantly increased for the healthcare and pharmaceutical...
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