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In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
Munger, Tolles, & Olson LLP (MTO) is an American law firm founded in 1962 with offices in Los Angeles, San Francisco, and Washington D.C. The firm is known for handling litigation and corporate matters across multiple industries, including entertainment, technology, energy, healthcare, and financial services.
Manatt, Phelps & Phillips, LLP is a Los Angeles-based law firm of more than 450 attorneys and other professionals founded in 1965. The firm earned revenues of $316.9 million in 2017. Donna L. Wilson is the firm's Chief Executive and Managing Partner.
Sheppard, Mullin, Richter & Hampton LLP, often abbreviated as Sheppard Mullin, is an international law firm headquartered in Los Angeles, California. The firm has over 1,000 [8] [9] attorneys located in North America, Europe, and Asia. Founded in 1927, the firm includes 10 major practice areas ranging from Antitrust to Tax, and also industry ...
List of largest law firms by revenue; List of largest United States-based law firms by profits per partner; List of largest United Kingdom-based law firms by revenue; List of largest Canada-based law firms by revenue; List of largest Europe-based law firms by revenue; List of largest Japan-based law firms by head count
Morrison & Foerster LLP; Headquarters: 425 Market Street San Francisco: No. of offices 17 (2019) [1] No. of attorneys 750 - 1000 (2019) [1] Major practice areas: Mergers and acquisitions, litigation and arbitration, corporate finance, corporate restructuring, securities, banking, project finance, energy and infrastructure, antitrust, tax, intellectual property, life sciences
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Cooley LLP is an American international law firm, headquartered in Palo Alto, California, with offices worldwide.The firm's practice areas include corporate, litigation, intellectual property, fund formation, public markets, employment, life sciences, clean technology, real estate, financial services, retail, regulatory and energy.