Perhaps you have recently identified and synthesized a new chemical compound that may treat unmet medical needs or is a superior improvement upon currently marketed medicines. You may now be wondering what the next steps are towards conducting clinical trials and FDA approval. Here are three benefits of utilizing the services of a professional clinical pharmacology consulting company that can do early-phase nonGLP pharmacokinetics research to help you with your unique chemical compound.
Consulting
One of the main benefits of utilizing the services of an experienced professional consultant is that they will advise on the most efficient next steps towards regulatory approval to start clinical testing or regulatory approval for commercialization. This means the trials’ design to generate useful data to drive regulatory interactions, scientific and regulatory writing in support of regulatory interactions, advise on the next set of research studies based on data from past research, and more.
In house Research Capabilities
Most consultants don’t come with their research lab. Another benefit of seeking assistance from a professional clinical pharmacology/pharmacokinetic consulting company with contract research services is that they can design and conduct your early nonGLP discovery pharmacokinetics and bioanalytical studies and take the data generated and model and simulate the exposure to develop the next set of nonclinical studies.
Working with a professional drug developer with extensive modeling and simulation capabilities will enhance early model-based drug design and provide you with high-quality, expert development advice.
Regulatory Experience and Compliance
Ensuring regulatory compliance standards can be overwhelming. Knowing that your consultants are experienced and well-versed in the ever-changing and expanding international, national requirements from GLP/GCP/CDISC and animal and human ethical research requirements provide for peace of mind.
Leading Industry Experts
Perhaps you are convinced that your consultants should bring more to the table than just past experience and are now searching for a company that offers clinical pharmacology consulting and contract research. If so, contact Xyzagen. They are a company located in North Carolina, near the Research Triangle Park. They offer their pharmacology and pharmacokinetics expertise and are leading industry experts in drug discovery and regulatory development. Call or visit today.
