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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.

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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

 

 


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