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