Preclinical Stage
At this early stage of development, your company may have in vitro and in vivo efficacy data (usually non-GLP), a lab scale manufacturing protocol, a proposed therapeutic indication, and some intellectual property strategy (patents filed).
Establishing an infrastructure with full-time employees for each core competency can be prohibitively expensive to an early stage company. The Atheln team can provide an integrated, virtual product development team so that your company receives the expertise it requires at the appropriate time. Superior planning and execution of your R & D, Manufacturing, Regulatory, and Business Strategies at this stage will lead to time and cost savings as you advance your product to the clinic, as well as increase your probability of success.
The Atheln team starts with a thorough integrated evaluation of your existing information (GAP Assessment) to benchmark your plans against current regulations and practices, as well as market trends and competition. We can assist you in preparing a strategy and executing a plan in multiple areas, including:
- Intellectual Property
- Quality
- Regulatory
- Clinical
- CMC
- Business Development and Licensing
- Preclinical
- Commercial Support
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Detailed offerings are found in the attached PDF.