Accelerate Your Drug Development with
Expert Pharmaceutical Formulation Services

Formulation development plays a critical role during NDA and ANDA drug development. Creating a formulation that is clinically successful, stable, simple, and inexpensive to manufacture requires expertise in a variety of disciplines. Our highly qualified and experienced scientists are trained in all aspects of formulation development:
 
  • Material properties – are the chemical and material properties of both the drug molecule and drug delivery system suitable and coherent?
  • Drug Delivery and Biopharmaceutics – will the active pharmaceutical ingredient (API) and drug delivery mechanism successfully provide clinical benefit to the patient?
  • FDA Regulations – does the formulation meet FDA and regulatory requirements?
  • Manufacturing process development – is the formulation stable to be manufactured for clinical trial material? 
  • Scale-Up – can manufacturing of the formulation be scaled up to commercial volumes?
 
We utilize design of experiment (DOE) concepts to perform rapid formulation optimization studies aimed at developing an effective, stable, and safe formulation that can be easily manufactured.

50+ formulations developed

Good Manufacturing Practice (GMP) Certified

End-to-End
FDA Regulatory Support

Dedicated Quality Assurance (QA)

15+ ANDA submitted and approved

Our Dosage Form Capabilities

  • Oral Solid Dose (OSD): We are experienced in developing formulations including, but not limited to, single layer, multi-layer tablets, coated tablets, enteric tablets or capsules, powder filled capsules, multi-particulate coated bead capsule formulations for controlled release, and mini tablets.
  • Oral Liquid: We can formulate products into solutions or suspensions, depending on the drug load and its solubility.
  • Buccal: This dosage form is sometimes suitable for formulations with API that have poor oral bioavailability.
  • Topical: We can formulate products into creams, ointments, gels, or solutions.
  • Injectable: We can formulate products into solutions, suspensions, or solutions for reconstitution.
  • Ophthalmic: solutions, suspensions, gels, or ointment dosage form.

Formulation Solutions for Faster, Cost-Effective Pharmaceutical Drug Development

Frequently Asked Questions

Do you provide formulation development for early phase clinical trials?

Yes, we perform formulation development for Phase I, Phase IIa, Phase II, and first-in-human clinical trials. Development is performed in small scale to increase speed and decrease cost with the focus of developing an effective formulation that is stable through the length of the clinical trial. As an R&D-focused CDMO, we are able to manufacture small prototype formulation batches that save money and can be manufactured quickly. Typically, we can develop first-in human clinical trial formulations and manufacture cGMP clinical batches in a matter of months.

Our team is connected to a network of certified and approved sourcing vendors around the globe. As experts in analytical method development, testing, and FDA regulatory filings, our team brings this expertise when selecting both active and inactive ingredients to ensure that the formulations we develop comply with all necessary FDA requirements.