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Ethical drugs addressing unmet medical need
Regulatory Affairs
New product development planning
Patent strategy
Pre-clinical and Clinical development
Project valuation
Consulting, start-up, investment rounds.
Assess patent landscape
Regulatory strategy
Comprehensive development plan to NDA filing
Market research (prescribers and payers)
MISSIONSProvide clinical value to prescribers
The project stages:
- After targeting a specific indication and identifying potential drugs, the company’s associates assess the patent landscape and draft a regulatory strategy such as 505 (b)(1) or 505(b)(2).
- A tentative development plan is prepared relying on FDA’s guidelines when available.
- Preclinical and Clinical development experts are hired to audit and validate the tentative plan.
- Specific market and economic researches help define the target product profile most likely to convince CMS and PBM (third party payers) to cover the drug’s cost once approved by FDA
- A patenting strategy is defined and becomes part of the development plan.
- When requested by the client, a briefing package is prepared for a Type B pre-IND meeting at FDA.
EXAMPLESLS Research projects
Hormonal intra vaginal ring
The ring elutes a hormonal substance to treat vulvovaginal atrophy.
Topical opioid
To relieve neuropathic pain
Oral route drug
That induces reversible aspermia for contraceptive use
Innovative 5-ASA rectal formulation
To treat ulcerative colitis.
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