888 PHARMACEUTICAL

888 Pharmaceutical is a Global Regulatory Affairs Consulting firm with over 30 years experience in providing regulatory submission support for new and complex post-approval generic applications (ANDAs) and new drug applications (NDAs). We have successfully filed and supported new drug applications for small generic pharmaceutical manufacturers as well as fortune 100 pharmaceutical manufacturers... 888 Pharmaceutical can assist your teaming the development of a filing by employing their eCTD authoring, reviewing, and publishing capabilities. eCTD publishing services provide comprehensive support, from SPL creation and submission to ESG transmissions and account generation. Our team of experts ensures seamless electronic submissions, maintaining the highest standards of data integrity and regulatory compliance... Our compliance auditing services encompass a wide range of standards, including cGMP, ISO, USP-NF, and more. We specialize in gap analyses, document compliance, QMS..

Also known as: 888 Pharmaceutical LLC

Primary location: Boise United States