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- Determining study feasibility
- Liaising with all regulatory bodies
- Study design
- Selection of a Clinical Research Organisation (CRO)
- Managing clinical study activities
- Analyzing study data
- Interpreting study results
- Submissions
HT Pharmaceuticals has the technical understanding and experience to design, manage and run Phase I-III Clinical Studies in collaboration with a CRO. With 15 years diverse experience in the pharmaceutical industry, HT Pharmaceuticals can take your generic compound and determine the number of studies required, design the bioavailability/bioequivalence of a pharmacokinetics study, select a suitable CRO and work closely with the CRO to produce a complete dossier for submission to a regulatory body.
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Many small pharmaceutical companies world-wide do not have the biopharmaceutics expertise to handle this aspect of their study. There are also medium to large size pharmaceutical and biotechnology companies that have too much work in-house and need to contract out some of the biopharmaceutics or other aspects of a study. Follow the link to Who We Can Assist to determine if any of the scenarios described relate to your situation/need. If so, HT Pharmaceuticals may be the consultancy to assist you.
Further information about HT Pharmaceuticals
For further details and other activities of HT Pharmaceuticals, please follow the link to Services. For a full presentation about HT Pharmaceuticals, please follow the link to Presentation. To determine how HT Pharmaceuticals may help address your specific needs, please follow this link Request for Information. To contact HT Pharmaceuticals, please follow this link Contact Us.