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Brochure

Formulation Development Solutions

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Accelerating your molecule from discovery to clinic, our integrated formulation services support everything from preformulation to FIH (First-in-Human) and GMP clinical manufacturing. With co-located teams and deep NCE expertise, we deliver clinic-ready drug products with speed, science, and scale.

Proof of Performance

What We Do (End to End)

Preformulation & Developability (Preclinical)
  • Physicochemical & solid-state profiling
  • Salt/co-crystal screening, polymorph selection
  • Scalable crystallization (PAT-enabled)
  • Bio-relevant solubility mapping
  • Risk-based developability assessments
Toxicology & PK Enabling Formulations (All Routes)
  • Fit for purpose suspensions, solutions, and powder
  • Enabling technologies: spray dried dispersions, particle engineering (micro and nano sizing), lipid-based and complexation-based systems to address poor solubility/bioavailability
  • Drug delivery systems: micro /nano emulsions, nanosuspensions, liposomes, in situ gels, microparticles/LAI, LNPs, concepts where
    appropriate
Clinical Formulation Development (Phase Appropriate)
  • DS/DP integration: from API to final dosage
  • Phase-appropriate specs, stress testing & bridging strategies
  • CMC DP strategy: DIC/DIB liquids, tablets, capsules (incl. neat, blend, pellets), select parenteral approaches
  • QbD-driven development & analytical
    validation
Clinical Manufacturing & Supply (GMP)
  • Solid orals (GMP): immediate and modified release tablets (incl. mini tablets), DiC, DiB, film coated tablets,
    capsule filling (neat, blend, pellets)
  • Enabling oral formats: SDD powder (as blend/capsule/tablet), micronized API fills, Nano-sizing technologies
  • Select parenteral/ophthalmic formats at R&D scale; tech transfer options as needed
  • Integrated services: labelling/packaging, IMP/clinical supply, and stability per ICH where applicable

 

Quality, Compliance & Documentation
  • Phase appropriate GMP and QA oversight
  • Global audit readiness
  • Method validation aligned to development phase
  • ICH stability and clinical supply packages
  • Robust CMC documentation to support IND/IMPD
    filings
Flexible Engagement Models
  • Standalone or integrated DS/DP programs
  • FFS or FTE, scaled to your needs
  • Flexible tech transfer and scale-up options; transparent governance and PMO

 

Why Aragen

  • 20+ years of NCE expertise: Preformulation and clinical development
  • Co-located functions: Chemistry, biology, DMPK, materials science, formulation, analytics, and GMP
    clinical manufacturing
  • Speed + Science + Scale: Rigorous science, accelerated timelines, and scalable solutions