Perficient: Drug Development

JUNE 25, 2024

To do this, utilize PDFBox, a Java library for managing PDF documents, in combination with Selenium, a potent web automation tool. Key Features: PDF Creation: Enables the creation of new PDF documents from scratch. Encryption and Decryption: Provides functionalities to encrypt and decrypt PDF files to ensure document security.

Packaging 52

Packaging 52

Perficient: Drug Development

OCTOBER 26, 2023

We recently completed an upgrade project, and one of the notable changes we made was incorporating TinyMCE into its own NuGet package. Since I referred to various online sources to execute this, I’ve documented the process below. With the latest version, several adjustments have been made to the implementation process.

Packaging 98

Packaging 98

Perficient: Drug Development

JULY 19, 2023

Salesforce provides extensive documentation that lists the available metadata types and their specific XML names. Salesforce’s Metadata API documentation offers a comprehensive list of available component types to help you make the correct selections. Now, let’s discuss a code snippet and understand its contents: <?xml

Packaging 52

Packaging 52

Perficient: Drug Development

OCTOBER 14, 2024

Example: An electronics company classifies items into components, finished products, and packaging materials. Example: A pharmaceutical company classifies its items into active pharmaceutical ingredients (APIs), excipients, and packaging materials.

Packaging 52

Packaging Compliance Production Pharmaceuticals 52

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 52

Packaging Compliance 52

The ChEMBL-og

APRIL 16, 2024

New data have been included in the VERSION table to show the version applied for MeSH and EFO ontologies, the ChEMBL_Structure_Pipeline, RDKit packages, InChI, UniProtKB, Bioassay Ontology and Gene Ontology as well as the version of the ChEMBL database. University of Dundee: T. 1813 bioactivities in total have been added.

Clinical Trials 108

Clinical Trials FDA Cell Based Assays Compound Screening 108

Agency IQ

AUGUST 23, 2024

The document, which focuses on the “substantially similar mixtures” bridging principle and weight-of-evidence considerations, is a good indicator of where European authorities are likely focusing their limited resources in the context of CLP enforcement. Currently, the CLP is aligned with the seventh revised edition of the GHS.

Packaging 40

Packaging Regulations Compliance Production 40

Perficient: Drug Development

NOVEMBER 10, 2023

In this simple example, a content package is deployed with the aio aem:rde :install command. There are many commands available to use with the RDE including login, installation , deletion of bundles and packages , status, and even resetting or restarting the RDE.

Packaging 105

Packaging Licensing Licensing International 105

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 40

Clinical Trials Trials Compliance FDA 40

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 57

FDA Regulations Packaging Compliance 57

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 40

Regulations Packaging Compliance Production 40

Advarra

SEPTEMBER 8, 2022

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. Electronic records aren’t just limited to documents – they can be records in a database such as electronic case report forms (eCRFs).

Compliance 52

Compliance Regulations Clinical Trials Packaging 52

Agency IQ

NOVEMBER 20, 2023

readability of package leaflet, patient engagement). Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. The report recognized the potential for an electronic format for Product Information (i.e.,

Production 40

Production Packaging Hospitals Regulations 40

Perficient: Drug Development

AUGUST 9, 2023

You can download it from the official Redis website or use package managers like apt or brew. You can use the redis package available via npm: npm install redis Now, in your Node.js Useful Links: Node Official Site: [link] Redis Official Documentation: [link] Github Code: [link] Setup: Ensure you have Node.js Redis and Node.js

Packaging 96

Packaging Engineering 96

The Open Targets Blog

OCTOBER 24, 2023

  Together with Ray Kamalika, a research bioinformatician at OMass Therapeutics, he developed Otargen , an R package offering a suite of functions to facilitate the retrieval and analysis of Open Targets Genetics data, including specialised plotting functions to help visualise the information.   Have you used Otargen?

Bioinformatics 64

Bioinformatics Packaging Pharmaceutical Companies Pharma Companies 64

Perficient: Drug Development

MAY 1, 2024

Note : Content Search API will require CORS policy to be able to work, to read more about the configurations, please refer to this document for details. Just installing the packages and it’s enough for most cases. You also have to reindex the site after installation. Just like others, this approach also has props and cons.

Packaging 105

Packaging Production 105

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 40

Compliance Regulations Packaging Production 40

Drug Target Review

AUGUST 7, 2024

Packaging is typically the patient’s first interaction with a product, and it is critical for communicating safety and benefit-risk information. High quality artwork ensures that the product packaging conveys reliability and professionalism to foster trust within the product.

Drug Development 59

Drug Development Clinical Pharmacology Clinical Trials Packaging 59

Practical Cheminformatics

JANUARY 3, 2022

In order to make my life, and perhaps yours, a little easier, I put together a Python package called " useful_rdkit_utils ". One interesting component in the library is a REOS class that encapsulates the functionality in the rd_filters package I released a few years ago. I made the package easy to install.

Packaging 40

Packaging Science 40

Perficient: Drug Development

NOVEMBER 7, 2023

The framework is equipped with both Python and JavaScript packages. Here are some of the key applications of LangChain: Document Analysis and Summarization Chatbots: Employing LangChain to develop interactive and natural language-based chatbots for customer support, appointment scheduling, and client inquiries. How does langChain work?

Packaging 52

Packaging Engineering Research 52

Agency IQ

SEPTEMBER 15, 2023

In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging. PHGs are nonregulatory limits of a contaminant in drinking water that is not expected to pose a risk to public health.

Regulations 40

Regulations Packaging Production Organic Chemistry 40

Perficient: Drug Development

FEBRUARY 19, 2024

Document-less servers, like Eureka Server, are known. The details appear as follows when we publish several instances of various microservices to an R&D server like Eureka Server. Diagram: – Eureka Server Internal Structure. To put it another way, the server does not contain any XML or JSON files.

Packaging 101

Packaging International 101

Perficient: Drug Development

AUGUST 14, 2023

Document all actions taken in Google Optimize. Documentation Checklist should include: A/B testing results Personalization campaigns Goals and Metrics setup Google Analytics audience setup Development workflows and troubleshooting documentation 2. Remember, the best tool for you depends on your specific needs and context.

Packaging 98

Packaging Marketing Trials Production 98

Agency IQ

SEPTEMBER 6, 2023

But as a new guidance document clarifies, the FDA need to receive certain information from companies to make this meeting type work, and its not in a rush to receive requests, either. That draft guidance document, Post-Warning Letter Meetings Under GDUFA , has just been published. What should the meeting request package include?

FDA 40

FDA Packaging Drugs Pharmaceuticals 40

Perficient: Drug Development

FEBRUARY 29, 2024

All the mutable scala collections will be under this package – scala.collection.mutable. Mutable Collections (from scala.collection.mutable package): Scala provides various other mutable collections like ArrayBuffer, HashMap, Queue, LinkedList, etc. Let’s explore some mutable data structures.

Packaging 52

Packaging 52

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. Key Takeaways Our Premier Consulting regulatory experts help biopharma clients stay abreast of evolving FDA guidance documents and their importance to sponsors in 2023 and beyond.

FDA 52

FDA Compliance Regulations Production 52

Olympian Clinical Research

JUNE 27, 2023

Typically, it’s wise to avoid: Dairy products and their alternatives (cow’s milk, cheese, butter) Gluten-containing grains (wheat, barley, rye) High-sugar foods and refined carbohydrates (sugary treats, sodas, processed snacks) Processed and packaged foods with additives, preservatives, and artificial ingredients.

Clinical Research 52

Clinical Research Packaging Doctors Production 52

Perficient: Drug Development

OCTOBER 30, 2023

I accidentally had my max depth set at 0 and only got one document. Document Extractors ( Part 4 ) As mentioned in this article, there are three types of document extractors. A document extractor can have multiple extractors. I’ll cover advanced document extractors in a future post. CSS, Xpath and JS.

Production 52

Production Packaging 52

FDA Law Blog: Biosimilars

JULY 10, 2023

In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). When referencing documents within the AI response, cite location within the 510(k) supplement (e.g., Attachment number) and document name or description as appropriate.

FDA 75

FDA Packaging Laboratories Engineering 75

Advarra

JULY 19, 2022

A: For all vendors, having documented qualifications prior to use is important. For GMP vendors, documented reviews of records such as analytical testing and batch records, is also important. The auditor prepares by reviewing relevant information, such as contracts, as well as select QMS documents and records.

Packaging 52

Packaging FDA Trials Regulations 52

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 44

Packaging Compliance FDA Production 44

The ChEMBL-og

MAY 5, 2021

The recipe builds and automatically uploads the library to Julia's general package registry. Having an installable version of the MinimalLib from Julia's package registry made the work of writing the wrappers much nicer. Some documentation is also available here.

Packaging 52

Packaging 52

Perficient: Drug Development

NOVEMBER 21, 2024

Install Vue and Vue-Property-Decorator To start, open your terminal and run the following command to install Vue and the vue-property-decorator package, which we’ll use to leverage TypeScript decorators: Step 1.2: For further reading on event handling in Vue.js , check out the official Vue documentation on event handling.

Packaging 52

Packaging 52

The Premier Consulting Blog

APRIL 15, 2024

It is critical that the nonclinical program outlined in the PIND briefing document is presented in a manner that allows FDA to provide relevant input on the required IND-enabling studies. For example, if the nonclinical data presented in the PIND briefing document lacks information on the potential toxicity profile of the drug (e.g.,

FDA 52

FDA Pharmacokinetics Laboratories FDA Approval 52

Agency IQ

JULY 26, 2024

FDA finalizes guidance on electronic submissions for OTC products FDA has fulfilled its commitment under the Over-the-Counter Monograph Drug User Fee (OMUFA) program to issue final guidance on how sponsors can electronically submit monographs and other documents. What should be submitted to which portal? FDA-2022-D-2059

FDA 40

FDA Production Packaging Regulations 40

Perficient: Drug Development

FEBRUARY 14, 2024

In the past, deploying UI updates has required packaging them alongside OSGi bundles and HTL-driven components. Setting Up AEM Cloud Service Sites For this test drive, I followed the steps laid out in the AEM Quick Site Creation Journey documentation. They may not require all the features of a local AEM environment or maintaining one.

Packaging 52

Packaging Production 52

The Premier Consulting Blog

MAY 4, 2023

The new guidance provides detailed information to applicants and manufacturers regarding compliance with the requirements in 21 CFR Part 4 for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. Contact us to learn how we can support you in applying these guidance documents to your development program.

FDA 52

FDA Packaging Compliance Regulations 52