Regulatory Affairs Services
Clinical Trials India (CTI) is a Clinical Research Organization (CRO) helping Clinical Trials to obtain pharmaceutical product approval from regulatory affairs authorities and conducting clinical trials in an ethical manner comply with the GCP, federal, state and local government laws and regulations. We follow codes of conduct established for all employees.
Our Regulatory Affairs services are focused to end up with the success of the drug, keeping in mind the ethics concerned with the human health and life. The process begins with filing of application for new drug approval, continuing with the dossier preparation and submissions, dealing with the hurdles and finally ending up with the approval for conducting the clinical trials. We have under hand experience in the field of Clinical Research and Pharmaceutical Regulatory Affairs for almost two decades now. We assist the regulatory functions of world's leading pharmaceutical and biotech companies from development to market and beyond.
Our consultants are expert Regulatory Affairs professionals deeply focused to enable your access to all available resources. We provide you services tailored to fit your needs, complying with the standards and norms of the government. Besides taking the approval for new drug Clinical Trials India services for Regulatory Affairs include
- Dossier submissions
- Regulatory development
- Regulatory training program like clinical quality assurance
- SOP writing
- Clinical compliance support
- Adverse event reporting
The consulting services support you on regulatory concepts and strategies for submissions, technical development and registration of drugs, and pre clinical and clinical testing of biotech products. The regulatory affairs have been categorized into two divisions, namely,
The fundamental services for both the divisions remain the same except for the paper work.
