This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
The biggest enticement that large pharmacy benefit managers offer to the employers that hire them is drug rebates — a steady stream of money sent back to their clients, a tangible symbol of the discounts that PBMs are able to wrangle out of pharmaceuticalcompanies. Continue to STAT+ to read the full story…
A pharmaceuticalcompany and its chief executive — who once defended Martin Shkreli for raising drug prices to controversial heights — agreed to pay up to $50 million to settle allegations of purposely underpaying Medicaid rebates. Department of Justice.
By offering comprehensive and audit-proof documentation, the platform aims to simplify regulatory approvals and reduce time-to-market for pharmaceuticalcompanies. It contains revision dates, test results, certifications, and regulatory documentation.
In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceuticalcompany for such lapses.
Drug patents are a form of intellectual property protection that grants pharmaceuticalcompanies exclusive rights to manufacture, sell, and profit from their innovations for a set period. This exclusivity is the lifeblood of the industry, allowing companies to recoup their substantial R&D investments and fund future discoveries.
Pharmaceuticalcompanies that obtain a certificate can then use the document to satisfy customers — such as government agencies — that are increasingly incorporating environmental metrics in purchase agreements.
Here are seven key compliance challenges that Indian pharmaceuticalcompanies often face: 1. Labour law compliance across states Pharmaceuticalcompanies operate large plants and labs across multiple states, often employing a mix of permanent, temporary, and contract workers.
Quality Documentation and Manufacturing Expertise CDMOs are experienced in generating high-quality documentation required for regulatory submissions and have extensive expertise in drug development and manufacturing.
Jayakumar also spoke about the detailed procedures and SOPs needed for investigating market complaints and how these systems should be integrated into a companys overall quality management system.
So grab that cup of stimulation — our flavor today is butter pecan, a household favorite — and get started. Meanwhile, do keep us in mind if you hear anything interesting. We hope you have a simply smashing day and emerge unscathed. And the SEC wants to know whether Inotiv complied with the U.S.
Challenge Syner-G was contracted by a US PharmaceuticalCompany to help improve the quality of submission documentation generated during the manufacture of a Drug Substance intended for Phase II trials. Results Syner-G reviewed each documentation and provided suggestions/comments/guidance to the CDMO to bridge the gaps observed.
Discover the leading patient adherence pharmaceuticalcompanies. Pharmaceutical Technology has listed the top patient adherence pharmaceuticalcompanies based on our intel, insights and decades-long expertise in the sector. Patient adherence.
These developments are influencing pharmaceutical operations by improving research and development (R&D), manufacturing processes, and regulatory compliance. GenAI is being applied to multiple functions in pharmaceuticalcompanies.
According to internal documents obtained by the Observer , Novo Nordisk wanted “data from the Department for Work and Pensions” to “ help profile those who are most likely to return to the labour market”. These individuals could then be targeted with Wegovy, the brand name for the company’s weight-loss drug semaglutide.
Patent term extension is a regulatory mechanism that allows pharmaceuticalcompanies to extend the patent term of their products by up to 5 years. PTE is essential for pharmaceuticalcompanies to maintain market exclusivity and protect their investments. What is Patent Term Extension?
According to the Janssen PharmaceuticalCompanies of Johnson & Johnson and NICE, DVCd is recommended for the rare bone marrow disorder, only if daratumumab is stopped after 24 cycles of treatment, or earlier if the condition progresses.
In India, pharmaceuticalcompanies responded to global environmental concerns and government mandates by adopting greener manufacturing techniques. Indian companies will need to enhance their quality control mechanisms, data management systems, and documentation practices to comply with these demanding standards.
Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. This includes: Preclinical studies Clinical trials Regulatory approval Manufacturing and marketing Throughout this process, pharmaceuticalcompanies seek to protect their investments through patents.
Some pharmaceuticalcompanies are increasing their R&D spending to increase product numbers. With major pharmaceuticalcompanies implementing these approaches, this is a major contributing factor to rapid growth of this sector. Also noted in the report was the shift towards cloud-based systems.
Officer-Executive-Production (API) -B.Sc (Chemistry) with 2 to 5 years of relevant experience in API Production of pharmaceuticalCompany. Should have exposure to regulatory requirement of documentation. Should have exposure in handling reactors, centrifuges and clean room equipment with sound knowledge in cGMP and SOPs.
In a document outlining the charges against Shafat Quadri, of North Potomac, Maryland the US Department of Justice (DoJ) referred only to “one of the largest pharmaceuticalcompanies in the world” based in New Jersey.
Sponsors and developers of AIs – including pharmaceuticalcompanies – should set up governance structures to oversee algorithms and AI deployments that are closely linked to the benefit/risk of a medicinal product.
In total, the frequency of sentences related to cloud computing between April 2021 and March 2022 was 133% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,422 sentences, 19 (1.3%) referred to cloud computing.
Apply Now Job Description Bharat Parenterals Limited is a Gujarat based pharmaceuticalCompany , established in 1992 by Mr. Ramesh Desai, who started the Company with a vision of making world class affordable medicines in Gujarat. Review of the dossiers, DMF & Technical documents.
a Specialty PharmaceuticalCompany engaged in Development, Manufacturing and Marketing of quality finished dosages in domestic and International markets is looking for suitable candidates for its formulation facility at Dahej, Bharuch, Gujarat. Ajanta Pharma Ltd.-Walk-In Job Description. Ajanta Pharma Ltd. , Maintain social Distancing.
As a Contract Development and Manufacturing Organisation (CDMO), companies such as Bachem play a crucial role in supplying Active Pharmaceutical Ingredients (APIs) to biotech and pharmaceuticalcompanies, with responsibilities including raw materials management, process development and validation, production, purification, and delivery.
Prior to selling drugs or medical products in any country, pharmaceuticalcompanies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. Remaining compliant is imperative to the life sciences industry, so adhering to regulatory requirements is mandatory.
pharmaceuticalcompany to oversee a 6 month, DS manufacturing as Person-In- Plant (PIP) and assist with preparation of associated submission documents related to Phase III clinical trial batches. pharmaceuticalcompany achieve on time for Phase III clinical trials appeared first on SYNER-G.
According the PDA, the standardised quality criteria in TR 43 are intended as a guidance overview for container manufacturers and for incoming container acceptance inspection at pharmaceuticalcompanies.
is an integrated global pharmaceuticalcompany, committed to providing affordable and innovative medicines for healthier lives. Through its three business-Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products. Reddy’s Laboratories Ltd.-Walk-In Job Description. Dr. Reddy’s Laboratories Ltd.
UK-based pharmaceuticalcompany AstraZeneca has announced that is it voluntarily withdrawing its COVID-19 vaccine Vaxzevria due to a drop in global demand. The withdrawal also comes after AstraZeneca admitted in court documents that the vaccine can cause thrombosis with thrombocytopenia syndrome (TTS).
The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.
Comms company Envision Pharma Group has acquired doDOC Corp, a document collaborative review, editing and authoring firm. doDOC enables simultaneous collaboration in the review, editing, and authoring of documents among multiple users.
The pandemic has triggered a change in how pharmaceuticalcompanies are engaging with healthcare professionals. When IQVIA polled non COVID-19 treating Italian HCPs in March when the crisis was at its worst, it asked HCPs if they still welcomed pharmaceuticalcompany engagement during the crisis. The answer was yes.
Pharmaceuticalcompanies will need new standard operating procedures (SOP) to cover activities such as collaborative working, and new documentation to reflect changes in language. There may be a bit of a frenzy over the next few months as teams adapt to new concepts, language, new documents, SOPs, and clause numbers.
Should have exposure to regulatory requirement of documentation. Executive The incumbent should be B.Sc/ M.Sc (Chemistry) with 3 to 6 years of relevant experience (Pharmaceutical Only) in analyse the Raw Materials, In -Process and intermediates finished product and Stability samples. Quality Control (API): Executive/ Sr.
Emcure Pharmaceuticals- Openings for ITI Fitter/ Electrical Technician/ Electrical Engineer/ Instrument Engineer-Apply Now. Emcure Pharmaceuticals, We are a fast-growing Indian Pharmaceuticalcompany engaged in developing, manufacturing, and marketing a broad range of biopharmaceutical products globally. Job Description.
Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”
Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Most of the information is submitted in the form of unstructured PDF documents, with data embedded into them. Submission status quo.
Brand Authority: By appearing at the top of search engine results, pharmaceuticalcompanies increase brand credibility among HCPs. Use a mix of: Branded Keywords: Drug names, pharmaceuticalcompanies, or treatment-specific terms. Competitive Keywords: Terms related to rival brands, helping capture market share.
Pharmaceuticalcompanies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. In 2014 Keith was fortunate to become a full-time salaried patient research ambassador at Liverpool Heart and Chest Hospital Trust.
Pharmaceuticalcompanies regularly transfer databases as they shift to new systems or change service providers in pursuit of higher quality and increased efficiency. Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon.
There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceuticalcompanies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.
We organize all of the trending information in your field so you don't have to. Join 11,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content