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Preclinical Toxicology and Pharmacokinetic (PK) Formulation Services Preclinical Toxicology and Pharmacokinetic (PK) Formulation Services

Preclinical Toxicology and Pharmacokinetic (PK) Formulation Services

Specialized formulation development services enabling accurate, reliable dosing for preclinical toxicology and pharmacokinetic studies

In early drug development, many promising candidates face challenges such as poor solubility, limited stability, and low bioavailability, which can hinder effective dosing and exposure in animal models. Our early-phase formulation development services are specifically designed to overcome these barriers, enabling successful preclinical toxicology and pharmacokinetic (PK) studies for both small molecules and peptides.

Our expert team of scientists have successfully delivered projects in wide range of areas like incomplete dissolution, low solubility, low oral bioavailability and targeted drug delivery through in-depth molecular characterization, various solubilization and enabling technologies.

Our Services for Preclinical Formulation Development

Many hits and lead NCEs get shelved from pharmacological and toxicity screening despite high potency because of poor bioavailability or suboptimal formulation. As a leading CDMO company, we have over a decade of experience in helping our clients overcome these challenges by enabling preclinical and GLP toxicology studies.

Speak to our experts

Our preclinical formulation development approach includes but is not limited to:

Oral Formulations

  • Suspensions
  • Solutions
  • Solid dispersions (including enteric-coated)
  • Lipid-based systems (Emulsion / SMEDDS)
  • Micro-/nano-suspensions

Parenteral Formulations

  • Sterile solutions
  • Lyophilized powders
  • Emulsions
  • Nano-suspensions

Formulations are customized based on routes of administration, animal species, dose requirements, and bioavailability goals.

Enabling Technologies & Expertise

  • Solubilization techniques: pH adjustment, co-solvents, surfactants, cyclodextrins
  • Particle engineering: Micronization, spray drying, nanosuspension technologies
  • In vitro & in vivo correlation: Integrated evaluation with biological models
  • Species-specific design: Rodents (mice, rats) and non-rodents (dogs, rabbits)
  • Preformulation assessments: In vitro precipitation, compatibility, and solubility screening

Analytical & Stability Support

  • Dose Verification: Ensuring content uniformity, homogeneity, and concentration accuracy
  • Stability Testing: Real-time and accelerated studies for GLP compliance
  • In-Use Assessments: Evaluating short-term stability and formulation robustness under dosing conditions

Regulatory and Quality Compliance

  • GLP-compliant formulation preparation and documentation
  • Excipients selected for safety and Phase 1 regulatory acceptability
  • Full traceability and QA oversight across formulation lifecycle

Why Partner with Us?

Proven expertise in early-phase formulation for toxicology and PK studies

Over a decade of experience as a leading CDMO supporting IND-enabling studies

End-to-end integration with bioanalytical, toxicology, and clinical teams

Rapid formulation development and dependable project management

Global quality standards with strong regulatory alignment

Virtual Tour

 

Connect with our scientific experts for your drug discovery, development, and manufacturing needs

We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.

Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.

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