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Molecule to Clinic

FreeThink Technologies is your drug development partner, offering integrated CDMO services that accelerate your small molecule compound from early development through first-in-human studies, with precision and regulatory confidence.

Why Work With FreeThink?

Science-Driven Drug Development

At FreeThink Technologies, speed isn’t just a goal—it’s our way of working. From the moment your project begins, every step is coordinated by our dedicated project management team to ensure clear communication and rapid execution, while meeting all regulatory requirements. Our scientists move with urgency and precision, applying world-class expertise to advance your drug into the clinic.

We don’t work in isolation: FreeThink partners seamlessly with trusted collaborators who share our commitment to speed and quality— delivering your molecule into clinical trials with confidence.

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Molecule to Clinic

 

Molecule to Clinic

API

Drug
Development

Drug Product
Manufacturing

Regulatory +
Clinical Operations

Molecule to Clinic

API

Drug Development

Drug Product Manufacturing

Regulatory + Clinical Operations

API Services

FreeThink scientists expertly support development of new chemical entities (NCEs) and 505(b)(2) pathways for repurposed drugs, ensuring comprehensive and efficient process completion.

  • Pre-formulation studies: Measure key data including solubility, permeability, and pKa
  • Salt form and polymorph screening: Customized to meet the specific requirements of each active pharmaceutical ingredient (API)
  • Solubilization expertise: Specialized in amorphous dispersions (e.g., HME, SDD) for APIs requiring enhanced solubility
  • API scale-up: Seamlessly transition API synthesis from lab to pilot scale with processes scalable commercial use
  • GMP manufacturing: Coordinate the production of API supplies in compliance with GMP standards

Click here to watch a video demonstration of ASAPdesign™.

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Drug Development

 

Our team expertly formulates APIs into drug products for clinical and eventual commercial use.

  • Analytical method development: Establish and validate methods for purity, potency, dissolution, and stability
  •  Formulation development: Design dosage forms tailored to the Target Product Profile (TPP) using FreeThink’s Accelerated Drug Advancement Process (ADAP) in close collaboration with clients
  • Rapid shelf-life determination: Utilize ASAPprime® software, where FreeThink is a global leader, for accurate shelf-life assessment
  • Preclinical assessment: Conduct animal testing as needed to evaluate drug product performance before clinical trials

Click to view: “What is ASAPprime®?”

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Drug Product Manufacturing

FreeThink specialists produce clinical trial materials with uncompromising quality and rigorous controls.

  • Process development: Adapt formulations and procedures from laboratory to clinical manufacturing scale
  • GMP production: Manufacture clinical supplies with strict quality controls under GMP standards
  • Packaging and distribution: Package, label, and ship dosages to clinical sites using quality systems
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Regulatory and Clinical Operations

FreeThink assures regulatory acceptability based on the agreed strategy and organizes clinical operations for efficient Phase I clinical trial execution.

  • Clinical trial strategy: Develop strategies for conducting clinical trials and hold regulatory meetings with appropriate health authorities
  • Regulatory documentation: Prepare filings and address queries for the FDA, EMA, and other regulatory agencies
  • Clinical site management: Identify sites and clinicians, managing contracts and logistics
  • Bioanalytical and pharmacokinetic analysis: Identify labs for drug, metabolite, and biomarker analyses, with modeling as needed
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FAQs

Q: What types of products do you develop?

A: FreeThink’s services focus primarily on drug products requiring clinical trials, including new active pharmaceutical ingredients (APIs), generics, and existing drugs with novel delivery systems (e.g., extended release, pediatric dosage forms) or new indications (under 505(b)(2) processes). Drug products include oral solids (tablets, capsules, powders for suspension) and injectable formulations. We are licensed to handle controlled substances.

Q: How do you decide which aspects of development are done at FreeThink’s facilities and which things are handled by partner companies?

A: For each step of the development process, clinical manufacturing, and clinical operations, we strategically select resources that best meet product needs, deliver timely results, and provide cost-effective solutions. While in many cases our internal resources are a good option, certain processes and specialized equipment requirements are optimally managed through strategic partnerships.

Q: What happens after a product goes into the clinic?

A: After a drug product is dosed in clinical trials, FreeThink will coordinate the bioanalysis of blood samples to establish the pharmacokinetics and will issue a report including adverse event reports and any relevant notes. If available, this analysis will include key metabolites and any biomarkers. In many cases, the first clinical trial (Phase I) can be quickly followed up with a Phase IIa trial, potentially using the same dosage supplies from the Phase I material. If the product continues to advance into Phase III and commercial, we will facilitate technology transfer of manufacturing operations to an appropriate CMO.

Q: What are typical timelines for taking a molecule to the clinic?

A: Formulation development for tablets typically is completed in about two months. Clinical manufacturing, packaging/labeling, and shipment to clinical sites takes about four months. For simple dosing to healthy volunteers in Phase I clinical trials, the process is generally complete in about three months.

Q: Can we gain additional IP as part of the development process?

A: Gaining patent protection for formulations or manufacturing processes requires a challenge with a nonobvious solution. FreeThink has successfully developed formulations and dosage forms that address critical challenges including drug stability, solubility, patient compliance, and controlled release. In some cases, sponsor companies have been able to successfully leverage these developments into patent protection.

Q: Does FreeThink develop fixed dose combination (FDC) products?

A: We have extensive experience in rapidly solving the analytical and formulation challenges involved in FDC development. Among such challenges is stability, an area where we are a global leader.

Q: Does FreeThink coordinate clinical research unit (CRU) testing of drugs?

A: In some cases, we will promote the use of CRUs to reduce timelines to human trials; however, this involves discussions about the risks involved in development. We can develop the process and compounding instructions as needed.

Q: What types of enabling technologies does FreeThink employ to solve issues with drug candidates?

A: We apply advanced solubilization strategies to challenging drugs. We have particular expertise in amorphous solid dispersions prepared by spray drying (SDD) or hot melt extrusion (HME), as well as self-emulsifying drug delivery systems (SEDDS). We also have extensive experience in controlled release technologies for both oral and injectable technologies. Osmotic drug delivery systems represent an area of specialized expertise, exemplified by our proprietary OzmoCAP® technology.