A Pharmaceutical Regulatory Strategy Consulting Firm Providing Expert, Professional Services in Risk Assessment and Management of Drugs in Development
We provide consulting services on development of regulatory strategy for US, EU or global pharmaceutical products using current regulations and/or guidance documents. We can review existing development plans (gap analysis) and provide guidance where needed. We also assist clients with regulatory agency interactions.
For clients in the study execution stage, we design studies, monitor at CROs and analyse data as needed. Our scope of services include efficacy and toxicology studies. We also manage and monitor human clinical studies. We develop risk assessment, mitigation and management strategies.
Services literature review, scientific writing, report wiriting, for proposal development in response to RFPs and grants.
Drug Development and Technology Transfer Services
You can find us at our new location below or you
can send us a message via our contact page.
11207-A Lockwood Drive, Silver Spring, MD 20901
Phone: 1.240.565.8933 Email: info@kandih.com