Early-Stage Development
Accelerating Discovery Through Smart, Strategic Development
At MedPharm, our Early-Stage Services are designed to build a strong foundation for success—guiding drug candidates from initial discovery through preclinical and Phase I development. We bring deep expertise in formulation science, process development, and analytical testing to help innovators de-risk early development, optimize their products, and accelerate progress toward clinical milestones.
With specialized focus on non-oral, non-invasive delivery routes, we offer comprehensive, phase-appropriate strategies that align scientific innovation with regulatory readiness, ensuring a seamless path from molecule to first-in-human studies.
Our Early-Stage Capabilities Include:
Pre-Formulation & API Characterization
- Solubility, stability, and degradation studies
- Excipient compatibility and selection
- Physicochemical property evaluation to optimize formulation strategies
Formulation Development & Prototype Preparation
- Development of multiple formulation prototypes (creams, gels, foams, sprays)
- Short-term stability screening to identify optimal candidates
- Selection and optimization of lead formulations
Early Process Development & Preliminary Scale-Up
- Initial process characterization to ensure scalability
- Identification of critical process parameters (CPPs) and risk mitigation strategies
In Vitro Testing & Early Analytical Support
- In vitro release (IVRT) and permeation (IVPT) testing
- Early method development and qualification for regulatory submissions
- Stability studies to predict shelf life and support preclinical filings
Regulatory and IND-Enabling Support
- Preparation of CMC (Chemistry, Manufacturing, and Controls) documentation
- Integrated support for IND and early-stage regulatory submissions
Why Choose MedPharm for Early-Stage Development?
- Deep expertise in topical, mucosal, ophthalmic, and transdermal product development
- Customizable programs tailored to molecule characteristics and business goals
- Integrated scientific, regulatory, and manufacturing expertise under one roof
- Accelerated timelines driven by advanced analytics and proprietary technologies
