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Regulatory Compliance Initiatives, Inc. is a health care consulting firm that is committed to assisting domestic and international companies with US FDA and international regulatory agency GMP, GCP and GLP requirements for drug substances, drug products, nutritional products, medical devices and medical foods.

Services include:

• Writing, assembly and submission of electronic INDs, NDAs, ANDAs, and Drug Master Files (DMFs) all in common technical document (CTD) format; 510(k)s; PMAs; applications for Orphan Drug designation; and citizen petitions;
• Clinical trial setup and management, including site qualification; training/initiation; monitoring; study audits; and sourcing contractors for testing, materials, manufacturing, packaging, and labeling;
• Installation of CAPA programs;
• Quality System/Good Manufacturing Practice Audits;
• Preparation for FDA Pre-Approval Inspections;
• Due Diligence audits for product and company acquisitions;
• Establishing Quality Systems; and
• FDA and DEA training programs.

We work with multinationals on global issues and assist companies and start ups in North America, Europe, China, India, Japan, South America, Mid-East, and Africa with the drug development process as well as getting to and beyond your first IND or ANDA. Our worldwide experience and client base provides assurance that we know your culture and your needs. Our team is fluent in English, Spanish, French, Mandarin, Japanese, Dutch and German.