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Clinical Research Opportunities in China and the Path to USFDA Approval - Whitepaper

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星期二, 十月 25, 2022
MAH, Cell, Clinical trial, Drug development, CTA, Marketing, FDi Magazine, USFDA, GlobalData, FIH, Cros, Lists of people executed in the United States, Asia-Pacific, CRO, Research, Plasma protein binding, NDA, Gene, Ownership, AU, Fine chemical, Pharmaceutical industry, Medical device, IND

The report was prepared for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China, and the relevant processes required for USFDA approvals.

Key Points: 
  • The report was prepared for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China, and the relevant processes required for USFDA approvals.
  • Novotech's Vice President, Global Head of Clinical Services Dr. Yooni Kim said: "China presents exceptional clinical opportunities with vast populations and word-class research facilities and KOLs.
  • This concise analysis of the pathway to USFDA approval expertly informs clinical stage biotechs about the China research benefits and how to manage any challenges.
  • The report details the regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful USFDA approval pathway.

The Biotech Landscape Webinar: Market Trends, Priorities, Predictions, and Pathways to FDA Approval

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星期一, 十月 17, 2022
Cros, Therapy, Cell, Drug development, Gene, Entrepreneurship, Senior, Goldman Sachs, Regulatory affairs, Turning Point, CEO, News, Clinical trial, AU, FDA, Ownership, CRO, Fine chemical, Asia-Pacific

SYDNEY, AU, Oct 17, 2022 - (ACN Newswire) - Novotech, the leading Asia Pacific biotech specialist CRO, and Endpoints News present a webinar for biotechs considering the clinical research opportunities in Asia Pacific and the regulatory pathways to achieving FDA approval.

Key Points: 
  • SYDNEY, AU, Oct 17, 2022 - (ACN Newswire) - Novotech, the leading Asia Pacific biotech specialist CRO, and Endpoints News present a webinar for biotechs considering the clinical research opportunities in Asia Pacific and the regulatory pathways to achieving FDA approval.
  • Novotech has operations across Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late phase biotech clinical research.
  • Consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution.
  • Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases.

Novotech India Recognised as "Best Workplaces for Women 2022" by Global Work Standards Authority

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星期三, 十月 12, 2022
People, Female, Culture, Cros, Life, Woman, Organization, Cell, 100 Best Workplaces in Europe, Drug development, Gene, Parity, Human, Gender parity, Certification, Great Places, Health, Workplace, AU, CRO, Leadership, Medicine, Management, Fine chemical, Asia-Pacific

To identify India's Best Workplaces for Women 2022, Great Place to Work India studied 1122 organizations that had:

Key Points: 
  • To identify India's Best Workplaces for Women 2022, Great Place to Work India studied 1122 organizations that had:
    According to Great Place to Work India: "We have observed that the Best Workplaces have gone above and beyond to create and sustain aspirational organizations.
  • We congratulate Novotech for being a role-model in India by fostering an equal and equitable workplace culture."
  • Novotech CEO Dr. John Moller said: "As a leading employer of women in India we are extremely pleased to be ranked among the top companies in India as a Best Workplaces for Women 2022.
  • Novotech's Chief People Officer Angela Edwardson said: "We are delighted that Novotech India has been recognized as a leading employer for women.