ATTENTION START-UP BIOTECH AND BIOLOGIC COMPANIES:
Retired Regulatory Affairs Executive with 30+ years of experience available for temporary and short-term work assignments
- Specializing in biotechnology/rDNA and biological products
- Preferred stages of development from preclinical to mid-stage (up to and including Phase 3)
- Regulatory expertise in therapeutic and preventative areas includes: oncology, infection, inflammatory, respiratory, cardiovascular, hematologic, metabolic, and neurologic
- Products types include anti-infectives, mammalian and bacterial recombinant-DNA derived products, plasma-derived biologics, vaccines
During these tough economic times…
- Where headcount is shrinking due to hiring freezes or downsizing but the workload is increasing
- Where venture capital money is becoming tighter and budgets are stretched
- Where the regulatory pathway through the FDA or international Health Authorities and government regulators is becoming more complex, uncertain, and slow to respond
- Where companies continue to need programs moving forward as fast and efficiently as possible
I will work with you to tailor a regulatory support plan specific to your needs and budget. I will provide senior level advice and work product without you paying for overhead cost or worrying about cost overruns. Email me at: cbetancourt@asdllc.net to find out how.