Clinical Development
As the development pathway continues and you have passed a key inflection point, your company is ready to embark on Phase 2 or 3 clinical studies. By now your understanding of the product and the process is deeper. Before embarking on costly clinical studies, it is essential to validate the competitiveness of your product profile to increase the probability that the clinical studies will address the needs of your multiple target audiences. At the same time, your regulatory strategy needs to support your commercial strategy. This is the time to optimize the manufacturing processes to achieve sustainable yields while maintaining or improving product quality, potency and safety. Analytical methods and validation of these methods provide a higher degree of confidence in the results obtained and should be optimized at this stage. The historical data available needs to be considered to set release criteria that are achievable while complying with applicable regulatory standards. Also, additional animal studies for Pharm/Tox/Carcinogenicity may be required as clinical development progresses.
The Atheln team can assist you in multiple areas including:
- Regulatory
- Clinical
- CMC (including process validation, analytical method validation, stability study design, optimizing release specifications, etc.)
- Business Development/Licensing support
- Preclinical
- Commercial Support
- Quality
|
|
|
|
|
|
|
|
|
|
|
Detailed offerings are found in the attached PDF.