Phone: (281) 367-3949
- Early phase development activities
- GCP audits
- GXP training
- Regulatory submissions
Quality. Integrity. Professionalism.
Regulatory Outsource Consulting, Inc. (ROC) is an independent consulting company that provides regulatory and quality assurance consulting services to biotechnology, pharmaceutical and medical device companies.
We are experienced in the development of gene therapy, recombinant protein biologics, and small molecule drugs in the biotechnology and pharmaceutical industries. Our experience includes, but is not limited to, the following therapeutic areas: oncology, immune deficiency, dermatology, neuromuscular disorders, cardiovascular disorders and gastrointestinal and metabolic disorders.
We are dedicated to assisting companies in taking their product candidates from the research and development stage through clinical trials and into the market. We help our clients meet U.S. and International regulatory, quality and clinical study requirements.
Our goals are to provide:
- High quality and timely deliverables
- Attention to detail
- Service tailored to the specific needs of our clients