Pharma Packaging Solutions

SEPTEMBER 15, 2022

Pharmaceutical packaging companies play a critical role in the pharmaceutical industry. They are largely responsible for keeping pharmaceutical products safe and secure as they travel through the supply chain. Thus, choosing a packaging company to partner with is a very important decision. Regulatory Compliance.

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Pharmaceutical Technology

JUNE 19, 2023

Meeting strict client timelines is essential for clinical trials, but complications can arise when dealing with investigational medicinal products (IMPs) across several countries. Staying informed of regulatory changes is crucial for businesses to ensure continued compliance and avoid disruptions in their operations.

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XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. Container Closure Systems. extractables and leachables).

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Pharmaceutical Commerce

JANUARY 31, 2024

Under the DSCSA law, wholesale distributors, re-packagers, dispensers, and other third-party logistics providers must implement interoperable and electronic tracing of prescription products at the package level.

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Roots Analysis

APRIL 20, 2022

Further, studies indicate that more than 100,000 tons of pharmaceutical products are consumed globally per year. This continuously growing pipeline of pharmaceutical drug products has inadvertently led to an increase in the demand for their associated primary packaging and Secondary Packaging solutions. .

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FDA Law Blog

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant. By John W.M. Truly, these are complex considerations.

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XTalks

MAY 5, 2022

The Paleo certification program is based on the organization’s principle of encouraging the avoidance of dairy products, genetically modified organisms (GMO’s), grains, highly processed foods and legumes, among other foods. Related: Will An Upcycled Certification Mark on Packaged Foods Resonate With Consumers?

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FDA Law Blog

MARCH 2, 2022

By Riëtte van Laack — On February 18, 2022, the US Consumer Product Safety Commission’s (CPSC) Office of Compliance and Field Operations issued a guidance for household substances not intended for household use under the Poison Prevention Packaging Act (PPPA). No, that is not a typo.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. Wholesalers can be either full-line wholesalers, who purchase the complete product line of a company, or specialised companies, which purchase speciality drugs to sell to clinics and hospitals. GDP and GMP advisory.

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Cloudbyz

MAY 24, 2023

Consumer products companies constantly strive to develop superior products that meet the ever-evolving needs of their consumer base. The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis.

Clinical Trials 52

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Roots Analysis

APRIL 15, 2024

The production of biologics involves high degree of fragility and sensitivity involving the need for complex manufacturing capabilities, such as fermentation, aseptic fill finish , adequate storage with controlled temperatures and analytical testing to offer quality products.

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FDA Law Blog

SEPTEMBER 26, 2022

Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §

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Production Compliance Manufacturing Regulation 40

Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Ensure that all marketing materials, including advertisements, websites, and social media content, provide clear and accurate information about your products.

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Pharmaceutical Technology

AUGUST 31, 2022

Decreasing product life cycle time, varying customer demands and niche products, as well as increasing the cost of manufacturing and shipment, all contribute to constraints on the supply chain. m filtration, this intrinsically safe WFI is produced with significantly less risk than other production methods.

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World of DTC Marketing

MARCH 9, 2021

eMail represents an opportunity for pharmaceutical companies to get closer to their customers while increasing adherence and compliance. Pharma has an opportunity to engage customers and caregivers via email but they can’t send out product flyers. The key to effective email marketing is segmentation and personalization.

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Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Ensure that all marketing materials, including advertisements, websites, and social media content, provide clear and accurate information about your products.

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FDA Law Blog

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. In addition, the final rule requires the submission of product information to the Global Unique Device Identification Data (GUDID).

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FDA Law Blog

AUGUST 27, 2023

The compliance policies described in the Guidance focus on the requirement that, beginning November 27, 2023, all trading partners generally will be required to use electronic-based approaches to meet the enhanced drug distribution security requirements set forth in in FDCA section 582(g)(1) (Enhanced Drug Distribution Security).

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pharmaphorum

OCTOBER 12, 2022

Primary Packaging Development. Explore updates to drug device combination product design approaches considering patient preference at the forefront with case studies from big pharma representatives. Delve into the considerations for material components for the development of primary packaging. Connected Drug Delivery Devices.

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FDA Law Blog

OCTOBER 31, 2021

Under SB 343, a product or packaging is not recyclable in California if: It includes components, inks, dyes, adhesives, or labels that prevent its recyclability; It contains intentionally added chemicals identified pursuant to regulations implementing section 42370.2(g)(4) g)(4) of the California Public Resources Code; or.

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Camargo

NOVEMBER 15, 2021

It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements. In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”.

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Pharmaceutical Technology

JANUARY 20, 2023

This is a more efficient alternative to batch manufacturing, combining multiple production stages into a single, continuous production line. According to Pharmaphorum, when Hurricane Maria hit Puerto Rico in 2017, more than 500 medical product facilities – producing 10% of all drugs consumed in the US – were affected or damaged.

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pharmaphorum

JANUARY 4, 2022

Provided as a cloud or on-premise solution, PRISYM 360 is designed specifically to address the unique complexities of medical device, clinical trial and pharmaceutical labeling and packaging artwork. About PRISYM ID. Media Contact: Andrew Baud, Distil,? andrew@teamdistil.com , +44 (0) 7775 715775.

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pharmaphorum

NOVEMBER 24, 2022

While many production environments across all verticals must remain hygienic for product integrity, the standards that regulate pharmaceutical cleanrooms are more stringent – with unique industry-specific standards governing their use. Pharmaceutical products are typically Class C (requiring an ISO 7 cleanroom) and Class D (ISO 8).

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FDA Law Blog

MARCH 28, 2022

Circuit held that products that simultaneously meet both the FD&C Act’s general “drug” definition and its more-restrictive “device” definition must be classified and regulated as “devices,” FDA issued an “ Immediately in Effect Guidance ” to implement the decision as applied to ophthalmic products.

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FDA Law Blog

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. In the pre-market area, Ms. In addition, Ms.

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Drug Discovery World

JANUARY 23, 2024

Sphere Fluidics’ range of novel cell encapsulation products for single cell analysis and isolation are aimed at easing customer workflows to accelerate scientific discovery.

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Cloudbyz

MAY 11, 2023

Investigational Product and Comparator Costs The costs of manufacturing, packaging, labeling, and shipping investigational products and comparators can add significantly to clinical trial expenses. Accurate estimation of investigational product and comparator costs is essential to avoid potential budget overruns.

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pharmaphorum

SEPTEMBER 15, 2022

It had been held up in the US by compliance issues that forced Mallinckrodt to change its packaging and labelling manufacturing facility and resulted in the FDA rejecting its application in February.

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The Pharma Data

MAY 26, 2023

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational advanced therapy products by minimizing their time-out-of-environment. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year.

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Pharmaceutical Technology

NOVEMBER 25, 2022

Formulation decisions made in the development of PDFs can have important implications for drug stability, patient compliance, and accurate dosing. Many of today’s drug products are complex release and combination products that require innovative formulation approaches and technology. Innovative solutions to complex challenges.

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pharmaphorum

MAY 27, 2022

As the shift to home working proliferated during the pandemic, work became decentralised – and many businesses were able to be productive with a workforce at home. You can read part one of this article here. Teams and Zoom became the backbone of communication and firms embraced new ways of working. About the interviewees.

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pharmaphorum

NOVEMBER 17, 2021

The Future of Drug Delivery and Combination Product Device Design. The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products. BOOK BY 29 TH OCTOBER AND SAVE £200.

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FDA Law Blog

MARCH 3, 2024

Biotechnology equipment includes genetic sequencers, mass spectrometers, polymerase chain reaction machines or any other equipment, components or accessories designed for the research, development, product, or analysis of biological materials as well as any software, firmware, or other digital components.

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Pharmaceutical Technology

MARCH 29, 2023

The ease and speed with which the test can be set up should also be considered, meanwhile, its compliance with traceability standards will affect its ability to be used in the production environment. Traditional, probabilistic CCIT methods fail to meet many of these criteria.

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pharmaphorum

JULY 13, 2021

“Whether it is a medical device company coming to terms with regulatory changes or a clinical trial organization adapting to the new world of decentralized trials, we want our customer to feel that they can call upon our expertise at any time to help them get the most out of the products we offer. For more information:?? .

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