Understanding the Regulations and How LabVantage Successfully Helps Customers Comply With These Requirements

Pharmaceutical, medical device, food & beverage and other companies in regulated markets are required to comply with government regulations, standards and guidelines that are designed to ensure the safety and quality of the products manufactured, as well as the security and integrity of data supporting such production. The U.S. Food and Drug Administration introduced 21 CFR Part 11 to regulate electronic records and electronic signatures used in several industries, while the European Union’s EudraLex issued Annex 11 to cover computerized systems in pharmaceutical companies producing medicinal products for both human and veterinary use.

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Syngene -Clinical Development

Syngene is a leading Asian CRO that provides a broad range of discovery, development, manufacturing and clinical development solutions to biopharma companies. Syngene's clinical development services span a broad spectrum of activities including human pharmacology, bioanalytical research, central laboratory, clinical operations, medical writing, medical monitoring, safety management, pharmacovigilance, clinical data management & biostatistics and regulatory services supporting early-phase through late-phase clinical development programs.

OTHER WHITEPAPERS
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The Next Generation of Rare Disease Drug Policy

whitePaper | April 7, 2022

The United States defines a rare disease as a condition affecting fewer than 200,000 people in the country or one in which “there is no reasonable expectation” of recovering research and development costs.1 Examples of rare diseases include genetically-linked cancers, cystic fibrosis, and debilitating pediatric conditions like Gaucher disease and spinal muscular atrophy

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2022 Global Life Sciences Outlook

whitePaper | January 3, 2022

While valuations for the life sciences sector in this past year have been mixed, the underlying performance and outlook for the

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Advancing drug development using in silico modeling

whitePaper | June 22, 2022

The technologic and pharmacologic advances that have enabled researchers to take aim at previously untreatable diseases have contributed to an increase in the number of molecules in the development pipeline that are challenging and difficult to manufacture.

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The convergence of the pharmaceutical and medicaldevices industries

whitePaper | May 26, 2022

The medical device and pharmaceutical industries each share in a mission to improve health outcomes, from prevention to intervention. As a result of this shared mission, integration and overlap between these two industries has been taking place for decades.

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How Specialty Pharmacy Can Drive Better Outcomes in Cystic Fibrosis

whitePaper | June 28, 2022

CF is a rare, autosomal recessive disease caused by mutations in the cystic fibrosis transmembrane regulator (CFTR) gene that encodes the CFTR protein, an anion channel normally present in the epithelial membrane.1,2

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A Vision for the Global Generic and Biosimilar Medicines Industry

whitePaper | May 22, 2021

One of the key roles of the generic and biosimilar medicines industry is specifically to promote the widest possible access to affordable medicines with high quality, safety, and efficacy for patients globally by introducing competition into the markets. Despite the many hurdles, the generic medicines companies have clearly lived up to the challenges posed by the pandemic as it is an industry that is quick to adapt and agile in manufacturing scale-up. During the outbreak of COVID-19, this industry was providing most of the medicines needed in Intensive Care Units to ventilate critically ill COVID patients. It is also providing most of the quality medicines dispensed around the world, especially for increasingly prevalent chronic diseases and is therefore a strong contributor to health outcomes globally.

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Spotlight

Syngene -Clinical Development

Syngene is a leading Asian CRO that provides a broad range of discovery, development, manufacturing and clinical development solutions to biopharma companies. Syngene's clinical development services span a broad spectrum of activities including human pharmacology, bioanalytical research, central laboratory, clinical operations, medical writing, medical monitoring, safety management, pharmacovigilance, clinical data management & biostatistics and regulatory services supporting early-phase through late-phase clinical development programs.

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