Puerto Rico When life sciences companies decide to transfer the production of new drug to Puerto Rico, extend an existing production line, or simply sustain existing operations, they can count on the support of a vast network of service providers with unmatched expertise in quality and regulatory compliance, from premarket approval (PMA)…
India In a context where even well-established, multi-billion-dollar domestic companies have received warning letters from the US FDA, quality compliance has clearly become strategically important across all layers of Indian organizations, including formulation and API companies as well as both B2B and B2C players. My approach is extremely simple: quality…
India One issue grinding the gears of the Indian pharmaceutical industry over recent years has been quality compliance. With a number of pharma manufacturers the recipients of warning letters from the US FDA, increased regulatory scrutiny has caused some consternation, but also progress in quality standards across the board. “I see…
Ukraine Vladimir Sayenko, founding partner, and Anzhela Makhinova, counsel, of the leading Ukrainian law firm Sayenko Kharenko, give an overview on the Ukrainian pharmaceutical industry in 2017 and explain the expansion of the firm into new practices in order to further respond to the needs of its clients. What has changed…
Hong Kong Joyce Wong, managing director for APAC at compliance solutions provider Polaris in Hong Kong, describes the company’s innovative solutions for its clients in the life sciences, the significance of basing its regional headquarters in Hong Kong, and increasing compliance across the industry. It is very atypical for a senior executive…
Mexico Alberto Wicker, CEO at Signufarma, explains how patient compliance programs can enhance the national healthcare system through reducing the cost of treatment as well as improving patients’ quality of life and showcases the added value of Signufarma’s business solutions to enhance the medical compliance of Mexican patients. Could you please…
pharma Escalate Sciences is a Puerto Rican specialized science-based consulting firm focused on R&D, tech transfer, process design & improvement, analytical development and characterization. The company also serves different aspects of the life-sciences industry including project management, validation, qualification, statistical analysis, facility start-up, regulatory & compliance, reformulation and testing services. Its…
pharma The director of MRA Regulatory Consultants, Henriette Vienings reveals the important role they play in helping pharmaceutical companies navigate South Africa’s regulatory environment, as well as the importance of the technological advancements in the sector. She also illustrates the various success factors that have allowed MRA Regulatory Consultants to remain…
regulation The Indian joint secretary for commerce and industry, interviewed at CPhI Worldwide 2014 in Paris, discusses India’s place in the global pharmaceutical landscape, and emphasizes the country’s contribution to the world’s health. India has gone to great lengths at this CPhI conference to brand itself and show the world…
compliance The president of CETIFARMA, the council created by the pharmaceutical industry in Mexico for ethics and transparency, discusses the tireless effort it has made to professionalize the compliance function in the industry as well as the growing importance of transparency and ethics in its relation with physicians and patients. …
maintenance Mr. O’Neill, you have been managing director of this company for 17 years. How have you evolved the business over that period? ESS was founded in 1991, and I joined the business in 1996. The company’s initial vision was to provide flexibility to the maintenance market in Ireland and its…
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