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USFDA Consultants Medical Device

Posted by Aniket Chaudhari on March 29, 2024 at 5:40am 0 Comments

Medical Device Manufacturers require USFDA Approvals to sell their products in USA. USFDA differentiates product approvals in Class I, II &III depending upon the risk associated. The submissions include self-certification, 510(k) and PMA depending upon the class of the product.IZiel implements an Outcome-Based Delivery Model to provide complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations thereafter. Our teams from USA…

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IQ OQ PQ Medical Devices

Posted by Aniket Chaudhari on March 29, 2024 at 5:40am 0 Comments

IZiel’s Onshore-Offshore Model works with 1 Onsite Member supported by a team of 3-4 engineers from our Technical Center in India. Typically, the data is collected, evaluated and evidence is developed from the process design stage throughout production. Our Model enables the company to complete the project faster and in a cost-effective manner.

Read more@ https://iziel.com/process-validation/

Form 483 Remediation

Posted by Aniket Chaudhari on March 29, 2024 at 5:39am 0 Comments

Medical device manufacturers receive observations (Form 483) and / or warning letters on completion of USFDA Audit. The document outlines any violations of Good Manufacturing Practices (GMP’s) such as the facility, equipment, processes, controls, products, employee practices or records.IZiel has successfully assisted medical device companies to resolve these observations with efficiency and accuracy.

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USFDA Regulatory Consultants

Posted by Aniket Chaudhari on March 29, 2024 at 5:39am 0 Comments

IZiel helps you to obtain US FDA and CE approvals for Class I, II & III Medical Devices. Our Regulatory Consultants in US, Europe and India have thorough knowledge of USFDA & MDR Requirements alongwith extensive experience in submissions and approvals. IZiel works with the company to develop comprehensive documents in compliance with the regulatory requirements.

Read more@ https://iziel.com/usfda-approval/

Tricorbraun acquires beverage packaging leaders

TricorBraun announced on 7 January 2022, that it has acquired beverage packaging leaders Zuckerman Honickman (ZH) and Vessel Packaging (Vessel), strengthening the company's position in the beverage packaging market.

"Our acquisitions of Zuckerman Honickman, a name synonymous with best-in-class beverage packaging, and Vessel Packaging, a leading Canadian value-added distributor of aluminum cans, bolster our ability to serve beverage customers with expanded offerings and services across North America," said Court Carruthers, president and chief executive officer, TricorBraun. "We are incredibly excited to welcome the ZH and Vessel teams to the TricorBraun family and look forward to investing in their continued growth."

All ZH and Vessel team members—including ZH president Michael Zuckerman, SVP of Strategy and Development Lorne Paskin and vice-president of Operations Jon Zuckerman, and Vessel Packaging chief executive officer Matt Leslie and chief operating officer Mitchell Evanecz—will remain with TricorBraun. The companies will operate as separate, stand-alone businesses, and the teams will continue to work out of their existing locations. Effective immediately, the companies will be known as Zuckerman Honickman, a TricorBraun company, and Vessel Packaging, a TricorBraun company.

Zuckerman Honickman – Serving the most iconic beverage brands

Zuckerman Honickman, a fourth-generation family-run business backed by more than 130 years of experience, provides innovative packaging to many of the most iconic beverage brands in the world, as well as entrepreneurial, breakthrough brands. The company serves customers in every beverage vertical including sports drinks, craft beer, cider, craft soda, wine, spirits, and more. Headquartered in King of Prussia, PA, ZH serves customers throughout the US and Canada.

"For more than a century, customers have relied on Zuckerman Honickman's deep expertise and innovative packaging solutions," said Michael Zuckerman, president, Zuckerman Honickman. "We know that TricorBraun shares the same dedication for going above and beyond for customers, and both teams maintain strong customer and supplier relationships. Zuckerman Honickman and TricorBraun's cultures are closely aligned, and we are excited to experience our next phase of growth with such a respected packaging leader."

With the ZH acquisition, TricorBraun grows its beverage offering and significantly expands its beverage and sustainable packagingexpertise. As part of the deal, TricorBraun also acquired Delta Industries, a subsidiary of ZH and a distributor of reusable trigger sprayers and bottles.

Vessel Packaging – Canadian value-added distributor of aluminum cans

Since its founding in 2013 as a mobile canning business to serve British Columbia's craft brewers, Vessel has developed into a one-stop shop for aluminum cans, offering everything from mobile canning and design services, to printed cans, can ends and carriers, shrink sleeving, and other labelling services. The company serves all major beverage end markets, including beer, wine, cider, kombucha, coffee, sparkling water, and ready-to-drink (RTD). Vessel has a national footprint with five locations across Canada (Vancouver, Calgary, Mississauga, Ottawa, and Montreal), and serves customers throughout Canada and the US.

"Our customers trust us as their packaging partner thanks to our reliability, expertise, and value-added packaging services," said Matt Leslie, chief executive officer, Vessel Packaging. "We are immensely proud of our strong reputation in the beverage industry, and we are very excited for our next chapter of growth with TricorBraun."

With the Vessel acquisition, TricorBraun expands its beverage offering, establishes a deeper position in aluminum cans, and grows its Canadian footprint.

Since its founding, TricorBraun has partnered with management teams to successfully acquire and further accelerate growth for more than 30 packaging companies.

Financial details of the agreements were not disclosed. JP Morgan Securities LLC served as the exclusive financial advisor to Zuckerman Honickman. KPMG Corporate Finance acted as the exclusive financial advisor to Vessel.

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