01 2025 May
Hidden Hurdles: Six Pitfalls to Regulatory Approval for a New Drug Application
Bringing a new drug to market is a long, complex, and costly journey. For biotech and pharmaceutical companies, the New Drug Application (NDA) submission is...
Read More17 2025 April
Characteristics of an Effective Leader in Drug Development
Drug development is a complex, high-stakes field where science, regulations, and business intersect. From early discovery to regulatory approval and market launch, drug development is...
Read More14 2025 April
Ensuring Safety In Drug Development
Pharmacovigilance (PV) is the science and activities related to detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. In the rapidly evolving...
Read More08 2025 April
The Value of a Fractional Chief Medical Officer
In the rapidly evolving world of biotechnology, the need for experienced leadership to guide companies through clinical trials, and product development is paramount. However, hiring...
Read More03 2025 March
The Value of Understanding Global Regulatory Agencies in Global Drug Development Consulting
In global drug development consulting, having significant regulatory expertise is a critical differentiator. Navigating the FDA, EMA, and other global regulatory agencies isn’t simply a...
Read More14 2025 February
What Makes an Effective Drug Development Consultant?
Biotech and pharma industries move on tight timelines. This reality is made even more difficult due to complex and cross-border regulatory landscapes. Finding the right...
Read More24 2025 January
Essential Steps for Hiring Drug Development Advisory in Biopharma Startups
Biopharma startups often need senior-level expertise as they navigate the drug development process. However, hiring a full-time executive can be financially out of reach. These...
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Julie Rosenberg, MD is a senior life sciences consultant with a proven track record of success in leading global drug development and pharmacovigilance programs.
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