STAT

JANUARY 19, 2023

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 pharmaceutical company for such lapses.

Documentation 96

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 96

European Pharmaceutical Review

JULY 18, 2023

Some pharmaceutical companies are increasing their R&D spending to increase product numbers. With major pharmaceutical companies 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.

Documentation 94

Documentation Pharmaceutical Companies Pharmaceutical Companies 94

STAT

JUNE 5, 2023

Pharmaceutical companies 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.

Documentation 86

Documentation Pharmaceutical Companies Pharmaceutical Companies 86

pharmaphorum

JANUARY 18, 2021

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 pharmaceutical companies in the world” based in New Jersey.

Documentation 87

Documentation Immunization Pharmaceutical Companies Pharmaceutical Companies 87

pharmaphorum

MARCH 26, 2021

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.

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies 59

STAT

AUGUST 16, 2023

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.

Research Laboratories 89

Research Laboratories Documentation Pharmaceutical Companies Pharmaceutical Companies 89

pharmaphorum

OCTOBER 12, 2022

Prior to selling drugs or medical products in any country, pharmaceutical companies 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.

Documentation 101

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 101

pharmaphorum

AUGUST 17, 2021

Sponsors and developers of AIs – including pharmaceutical companies – should set up governance structures to oversee algorithms and AI deployments that are closely linked to the benefit/risk of a medicinal product.

Documentation 116

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 116

The Checkup by Singlecare

APRIL 5, 2024

“Commonly, BCBS requires proof of a diagnosis of Type 2 diabetes and documentation that the patient has not adequately responded to other diabetes medications before approving Ozempic,” he says. When BCBS covers Ozempic, the out-of-pocket costs will vary based on the drug tier it falls in.

Insurance 78

Insurance Documentation Insurance Coverage FDA 78

European Pharmaceutical Review

JULY 5, 2023

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 pharmaceutical companies.

Packaging 75

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 75

Pharmaceutical Technology

SEPTEMBER 5, 2022

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. Selecting the best pharmaceutical wholesalers. Temperature control facilities and supply solutions. Warehousing and logistics services.

Documentation 52

Documentation Packaging Labelling Pharmaceutical Companies 52

Pharmaceutical Technology

JULY 19, 2022

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.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 98

European Pharmaceutical Review

SEPTEMBER 2, 2022

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.

Adverse Reactions 76

Adverse Reactions Documentation Medical Schools Packaging 76

Hospital Pharmacy Europe

AUGUST 17, 2023

GoCART aims to promote patient access to novel cellular therapies, bringing together different stakeholders, including healthcare professionals, health authorities, pharmaceutical companies, patient representatives, health technology assessment bodies, reimbursement agencies and medical non-profit organisations.

Hospitals 98

Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

Impact Pharmaceutical Services

AUGUST 9, 2022

As a result of repeat business, IMPACT (now part of Syner-G BioPharma Group) was contracted by a large, global pharmaceutical company to author the CSRs and accompanying submission documents to support a simultaneous US and EU submission for a combination respiratory product. and 2.7.2), and the Clinical Overview (Module 2.5).

Documentation 40

Documentation Pharmaceutical Companies Pharmaceutical Companies 40

European Pharmaceutical Review

NOVEMBER 15, 2022

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.”

Documentation 86

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 86

Pharmaceutical Technology

SEPTEMBER 15, 2022

The surge in diseases is spurring demand for constructive treatment solutions, which is expected to boost the sales of injectable pharmaceutical companies. The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies Communication 52

ISPE

JULY 7, 2023

He is currently co-leading the team working on an ISPE guidance document addressing Pharma 4.0™. We developed recipe management and manufacturing software which controlled and documented these processes.” After the reunification of Germany, many pharmaceutical companies were being built.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

SEPTEMBER 20, 2022

Contract marketing companies support pharmaceutical companies in creating, improving, and maintaining their brand, as well as reducing risk, and ensuring better product placement in the market. Identifying the top commercial dose (non-sterile) companies in contract marketing.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies hold permission to market their products directly to consumers. The direct-to-consumer marketing companies for pharmaceuticals are increasingly moving online as it supports the digitisation of information, enabling patients to take control of their health.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Communication Documentation 52

Pharmaceutical Technology

JULY 12, 2022

In total, the frequency of sentences related to digitalization between July 2021 and June 2022 was 400% 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 1,091 sentences, eight (0.7%) referred to digitalization.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

JUNE 28, 2022

In total, the frequency of sentences related to robotics between April 2021 and March 2022 was as frequent as 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, six (0.4%) referred to robotics.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 52

Pharmaceutical Technology

AUGUST 9, 2022

In total, the frequency of sentences related to artificial intelligence between July 2021 and June 2022 was 400% 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 2,465 sentences, 24 (1%) referred to artificial intelligence.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

JULY 5, 2022

Mentions of the future of work within the filings of companies in the pharmaceutical industry were 373% higher between April 2021 and March 2022 than in 2016, according to the latest analysis of data from GlobalData. Of the document's 1,725 sentences, seven (0.4%) referred to the future of work.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Fossil Remedies

OCTOBER 16, 2022

In a pharma business, you have a distribution network like a pharma manufacturing company, pharma marketing company, C&F agents, wholesalers/distributors/stockiest, retailers, and pharmacies. But apart from that, you need to put the effort into completing the documentation also. In the end, there are patients or customers.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

SEPTEMBER 26, 2023

Pharmaceutical companies 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.

Documentation 94

Documentation Data Entry Pharmaceutical Companies Pharmaceutical Companies 94

Pharmaceutical Technology

SEPTEMBER 8, 2022

Pharmaceutical compounding companies are expanding geographically and launching innovative products according to customer requirements to get a better foothold in the market. The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

Compounding 52

Compounding Compounding Pharmacies Sterile Compounds Dosage 52

ISPE

MARCH 16, 2023

The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. Automated systems offer a range of options for pharmaceutical companies. Environmental monitoring is another important aspect of Annex 1.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation Dosage 98

pharmaphorum

FEBRUARY 10, 2021

Pharmaceutical companies 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.

Documentation 111

Documentation Pharmaceutical Companies Pharmaceutical Companies 111

STAT

NOVEMBER 18, 2022

… Pharmaceutical companies could be made to disclose prices and deals for products they make to fight future global health emergencies, under new rules that would govern a World Health Organization-backed pandemic accord , Reuters reports.  A Or you may want to take stock of your life. But be safe. Enjoy, and see you soon.

FDA 89

FDA Documentation Compounding Pharmaceutical Companies 89

Impact Pharmaceutical Services

SEPTEMBER 20, 2023

Repurposing also offers an opportunity for smaller companies and universities to address areas of unmet need, which may not be in the competitive space of larger pharmaceutical companies. These indications could fall under the category of Orphan Drug Status and if successful, would be eligible for extended patent protection.

Documentation 59

Documentation Packaging Dosage Pharmaceutical Companies 59

Pharmaceutical Technology

SEPTEMBER 20, 2022

The increasing investment in pharmaceutical research and development, and the growing adoption of contract manufacturing and marketing practices are driving the demand for clinical trial contract packaging solutions. Finding the best clinical trial packaging services providers. Clinical trial packaging and labelling solutions.

Packaging 40

Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 40

Impact Pharmaceutical Services

AUGUST 21, 2022

In 2009, IMPACT (now part of Syner-G BioPharma Group) was contracted by a mid-size global pharmaceutical company to prepare 2 Phase 3 clinical study reports (CSRs) for a biologic agent for the treatment of Crohn’s disease. Download a PDF of this case study. Establishment of a Long-Term Medical Writing Partnership.

Documentation 40

Documentation Pharmaceutical Companies Pharmaceutical Companies 40

Pharmaceutical Technology

AUGUST 26, 2022

Earlier this month, the World Health Organisation (WHO) released a new guidance document with a strategic plan to counter TB on a national level. Sequella is a US-based pharmaceutical company that develops antibiotics to address drug resistant infections. Sequella is developing SQ-109 for the treatment of pulmonary tuberculosis.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation 98

Pharmaceutical Technology

SEPTEMBER 14, 2022

Prospects of clinical dose companies in contract marketing. The demand for contract clinical dose marketing services from the pharmaceutical industry is on the rise as pharmaceutical companies are concentrating more on saving their money and time as well as reducing the management burden by outsourcing marketing activities.

Communication 40

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 40

pharmaphorum

APRIL 28, 2021

A group of industry experts is set to explore how medical device, clinical trial and pharmaceutical companies can proactively manage labeling risk. Yet no matter the size of company, the principles of validation are the same. Experts to come together for compliance event . Wokingham, United Kingdom —?27?April?2021?—

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Pharma Marketing Network

MAY 3, 2023

Pharmaceutical advertisements play a significant role in shaping the industry as a whole, influencing both consumer behavior and healthcare provider practices. For example, advertisements can increase demand for certain medications, leading to increased sales and profits for pharmaceutical companies. Steinman, M. Landefeld, C.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52