Perficient: Drug Development

APRIL 17, 2025

Supports Legal Compliance Many accessibility laws, such as the Americans with Disabilities Act (ADA), require equitable designs to prevent discrimination. Universal Packaging Medication packaging with clear, readable labels benefits not only those with visual impairments but also older adults and customers in low-light conditions.

Packaging

FDA Law Blog: Biosimilars

JULY 15, 2025

The American Conference Institute’s 3rd Annual West Coast Forum on Legal, Regulatory, and Compliance for Cosmetics & Personal Care Products is scheduled to take place from October 8-9, 2025 in Santa Monica, California.

Compliance

PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drug products, drug substances and intermediates.

Packaging

Advarra

SEPTEMBER 8, 2022

After platform review, if a decision is made to validate, staff should generate documentation to ensure Part 11 compliance. As the first requirement in Part 11 compliance, validation is systematic documentation for a system’s requirements. This review can be documented in a vendor’s audit or within your own validation package.

Compliance

FDA Law Blog: Biosimilars

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M.

Compliance

Perficient: Drug Development

JUNE 4, 2024

By leveraging self-hosted runners for deployment, organizations can optimize control, customization, performance, and cost-effectiveness while meeting compliance requirements and integrating seamlessly with existing infrastructure and tools. Here are few advantages of self-hosted runners as given below.

Compliance

Agency IQ

FEBRUARY 15, 2024

European Commission unveils proposed ban on bisphenol A in food packaging The European Commission has proposed a total ban on bisphenol A and related substances for use in food contact materials. The declaration must state that the goods in question are in compliance with the rules applicable to them. eye damage, cat.

Packaging

Agency IQ

AUGUST 30, 2024

he good news: ECHA offers a treasure trove of online guidance on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Classification, Labelling and Packaging (CLP), and other chemicals legislation, as well as other reference tools to help industry keep products in compliance.

Packaging

Perficient: Drug Development

JULY 11, 2023

In this blog post, we will explore how OmniStudio empowers document generation across a range of industries, enhancing efficiency, accuracy, and compliance. To get the document generation capabilities, you need to install ‘OmniStudio’ and ‘Salesforce Industry packages in the same org. A sample functionality comes with the package.

Packaging

Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. Member states are to draft penalties for non-compliance by June 30, 2025. The proposed regulation is divided into 9 chapters.

Packaging

Perficient: Drug Development

OCTOBER 3, 2024

Support and Compliance: Upgrading ensures continued support from HCL and compliance with industry standards and regulations. Download and extract the Update Package that you want to install. Add Update Package Repository Go to File > Preferences on the Home page and then select Repositories. Click on Add Repository.

Packaging

Perficient: Drug Development

SEPTEMBER 26, 2024

Support and Compliance: Upgrading ensures continued support from HCL and compliance with industry standards and regulations. Download and extract the Update Package that you want to install. Add Update Package Repository : On the Home page, go to File > Preferences and then select Repositories. Database Update: 1.updatedb

Packaging

FDA Law Blog: Biosimilars

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. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

Packaging

Alta Sciences

APRIL 6, 2024

Let us navigate and mitigate these challenges for you with a team of logistical experts to: • Streamline regulatory compliance through optimized documentation practices. • Prioritize secure, temperature-controlled shipments with reliable couriers. • Ensure your samples maintain their integrity with temperature monitoring, robust (..)

Packaging

FDA Law Blog: Biosimilars

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.

Production

The Premier Consulting Blog

MAY 4, 2023

Food and Drug Administration (FDA) published in March of 2022 pertaining to ophthalmic drugs and devices, titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product.

FDA

The Premier Consulting Blog

MAY 11, 2023

In March of 2022, the agency issued a guidance document titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. The FDA granted a 12-month period for the affected applicants and manufacturers to develop appropriate policies and procedures to ensure compliance with the new requirements. solution eyedrops).

FDA

Perficient: Drug Development

JUNE 30, 2025

It provides tools to track experiments, package code into reproducible runs, and share and deploy models. ’s tracing to monitor the bot’s interactions, ensuring compliance with regulatory requirements and identifying areas for improvement. With the launch of MLflow 3.0, Automated Quality Evaluation MLflow 3.0

Compliance

FDA Law Blog: Biosimilars

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).

FDA

FDA Law Blog: Biosimilars

MARCH 3, 2024

This guidance will be critical because the Act leaves open a number of key questions that would be important to compliance and changes to the FAR are not required until a year after the guidance—and therefore after the effective date.

Government

Perficient: Drug Development

JULY 29, 2024

Setting Up Encryption and Decryption We’ll use the javax.crypto package in Java, which provides the necessary classes for encryption and decryption. Compliance : Helps in complying with security standards and regulations that mandate encryption of sensitive data. Selenium WebDriver library added to your project. getEncoder().encodeToString(encryptedPassword);

Packaging

FDA Law Blog: Biosimilars

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.”

FDA

Fierce BioTech

JANUARY 12, 2024

Key Learning Objectives: Gain insight into the strategic use of minitablets in drug lifecycle management Learn how minitablets can offer flexibility in dosing and improve patient compliance, particularly for pediatric patients Explore the convenience offered to patients through the packaging of minitablets in unit dose stick packs, optimizing accessibility (..)

Drugs

The Pharma Data

AUGUST 7, 2020

CluePoints provides clinical studies with risk management support package during Covid-19. Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, said: “The response to our complimentary risk assessment package has been fantastic. Download the e-book here. Source link.

Clinical Trials

Perficient: Drug Development

AUGUST 1, 2023

We tested component functionality, visual design, responsiveness, performance, usability, accessibility, and ADA, HIPAA, and SOC2 compliance. HTL Loader According to the README file, the “HTL Engine for JavaScript” is usually paired with the NPM package “ HTL Loader ” written by Thomas Jaggi and Tobias Bocanegra.

Engineering

PPD

OCTOBER 18, 2023

However, an effective CRO doesn’t just perform assays; it provides comprehensive project planning, and also compiles, analyzes and packages data into an actionable and appropriate format for each individual client. Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money.

Laboratories

DrugBank

SEPTEMBER 12, 2024

It enhances transparency by documenting the meaning, source, and context of each data point, which is crucial for maintaining compliance and making informed decisions about data usage.

Production

Agency IQ

MARCH 15, 2024

Background: SB 54 and its requirements On June 30, 2022, Governor Gavin Newsom signed into effect SB 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

Regulations

Perficient: Drug Development

JUNE 24, 2024

CTA Action Button (Shopify landing page) Composable Commerce Principles: Modularity : The commerce platform is decomposed into individual packages or components, each responsible for specific functions such as product management, cart, payment processing, search etc.

Compliance

Drug Target Review

AUGUST 6, 2024

Regulatory support is another critical service provided by CDMOs, helping navigate the complex regulatory landscape for ADCs and ensuring compliance with global standards. Their assistance in preparing documentation and data for regulatory submissions is invaluable.

Therapies

The Pharma Data

MAY 26, 2023

The 6,000-square-meter Shiga site opened in October 2021 to support customers both locally and globally, providing flexible clinical supply solutions, including primary packaging, Catalent’s FastChain ® demand-led supply, white glove handling and logistics. With sites in the U.S.,

Clinical Supply

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

Clinical Trials

The Premier Consulting Blog

NOVEMBER 8, 2022

e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., typical drug device, biologic device) Two or more separate components, co-packaged (e.g., The drug product is packaged and shipped as a solid powder. therapeutic drug/monoclonal antibody) Drug/device (e.g.,

Production

Perficient: Drug Development

JULY 29, 2025

Enterprises: Large organizations aim for infrastructure consistency, cost control, and compliance. Steps to Deploy the Entire Infrastructure Step 1 : Create an S3 Bucket with the default settings: Step 2 : Create a Layer for Lambda Function, including the latest version of Boto3, lint, yaml, and create a zip file of those packages.

Engineering

Drug Target Review

DECEMBER 5, 2024

2 However, utilisation of biological systems introduces variability and by-products, as well as a challenge unique to AAV production: the assembly of full capsids with correctly packaged DNA, partially filled capsids containing partial vector and/or host cell DNA, and empty capsids.

Therapies

Agency IQ

AUGUST 30, 2024

The good news: ECHA offers a treasure trove of online guidance on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Classification, Labelling and Packaging (CLP), and other chemicals legislation, as well as other reference tools to help industry keep products in compliance.

Compliance

Advarra

JUNE 6, 2022

This area needs to operate under full cGMP (manufacturing, quality control [QC], packaging, quality assurance [QA], and logistics). There may be cases when the existing process needs adjustments based on regulatory requirements, and/or compliance issues. managing projects, business, and compliance).

Compliance