Reguliance provides comprehensive US regulatory affairs consulting, project management and US Agent services for the pharmaceutical and biotech industry.
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US Pharmaceutical Regulatory Consulting - Reguliance LLC | dev.reguliance.com Reviews
https://dev.reguliance.com
Reguliance provides comprehensive US regulatory affairs consulting, project management and US Agent services for the pharmaceutical and biotech industry.
dev.reguliance.com
Regulatory Due Diligence - Reguliance LLC
http://dev.reguliance.com/regulatory-due-diligence
US Regulatory Affairs Support. Regulatory Assistance for Startups. Regulatory Due Diligence for Licensing and Acquisition. Reguliance provides regulatory due diligence services to pharmaceutical and biotech companies, investment banks, legal firms, and other consulting firms. Areas of expertise include:. Overall development plans and regulatory strategy. Chemistry, manufacturing, and controls, including proposed changes to CMC. IND, NDA and BLA regulatory evaluation. Areas of specialty include:.
Pharmaceutical Regulatory Assistance for Startups - Reguliance LLC
http://dev.reguliance.com/regulatory-assistance-for-startups
US Regulatory Affairs Support. Regulatory Assistance for Startups. Regulatory Assistance for Startups. Specialized Regulatory Assistance for Startups and Early Development Companies. Reguliance can help address the following questions for your specific development project:. Is there any benefit to filing FDA submissions or meeting with the FDA? What are the activities and timelines for FDA submissions and meetings with the FDA and how does this integrate with our other development activities? US Regulato...
US Regulatory Affairs Support - Reguliance LLC
http://dev.reguliance.com/us-regulatory-affairs
US Regulatory Affairs Support. Regulatory Assistance for Startups. US Regulatory Affairs Support. US Regulatory Affairs Support for Pharmaceutical and Biopharmaceutical Companies. Working with the FDA. Meeting with the FDA. End of Phase I/ II (EOP I or II) meetings. Pre-NDA or Pre-BLA meetings. Documentation for the FDA. Reguliance can assist you in preparing, reviewing, and submitting FDA required documentation including:. Orphan Drug Designation Requests. Investigational New Drug Applications (IND).
US Agent Services for Foreign Firms - Reguliance LLC
http://dev.reguliance.com/us-agent-services
US Regulatory Affairs Support. Regulatory Assistance for Startups. US Agent Services for Foreign Firms. Foreign firms are required by FDA regulation to use a registered US Agent for many interactions with the FDA. Reguliance has extensive experience in providing US Agent representation to small- and medium-size foreign companies. As your US Agent, Reguliance is your primary contact in all dealings with the FDA. Reguliance will work with your organization to:. US Regulatory Affairs Support.
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US Pharmaceutical Regulatory Consulting - Reguliance LLC
US Regulatory Affairs Support. Regulatory Assistance for Startups. Is our slogan for a reason - our goal is to help you achieve your regulatory development objectives and get your products to the market faster. Is the US Agent for a number of foreign pharmaceutical and biopharmaceutical companies providing representation for US orphan drug applications, IND applications, drug and biologic master files (DMFs), and facilities registrations. Has expertise in the following areas:.
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