Whether you are a small company focused on the development of a single new molecular entity or managing a large pipeline of pharmaceutical and biotech products, there may come a time when some extra resources could help you avoid costly delays.
Focal Point Medical Consulting has deep experience managing research and development programs for small molecule and biologic drug products, including manufacturing planning in an environment compliant with FDA Current Good Manufacturing Practices (21 CFR parts 210/211 and aseptic processing for sterile drug products). We provide solutions customized to your specific needs so that you get what you need, and only what you need, to stay on track to success.
Translational Science & Market Research
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Clinical Disease State Reviews and Competitive Intelligence
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Pharmacology-Toxicology Reviews
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Preclinical Study Support
Product and Process Development
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Target Product Profile Development Support
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ICH Q10 Quality System Implementation & Support