Product planning including goals, market conditions, regulatory paths and costs
The development of your product from conceptual- ization to FDA approval
Preparation of NDA's, 505(b)(2)'s, ANDA's, CBE 30's, IRBs, etc
Audits and inspections of GMP facilities and clinics to comply with FDA standards
Search and transference of API or the transference of abandoned products
The RRI Group of Companies is based near Charlotte, NC. We are a privately owned Pharmaceutical Regulatory and Management company, currently in the business of overseeing total product development projects (NDA's and ANDA's for example) for small to medium sized pharmaceutical companies, including specialty pharmaceutical companies and contract manufacturers and distributors.
