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Molecule to Clinic

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

Why Work With FreeThink?

For Clinical Trial Drug Development

Science-Driven Drug Development

At FreeThink Technologies, speed drives everything we do. From day one, our project management team coordinates every phase of drug development, ensuring clear communication, rapid execution, and regulatory compliance.

Our scientists apply world-class expertise to advance your small molecule candidate from preclinical development to first-in-human studies and beyond.

We partner with trusted collaborators who share our commitment to quality and speed, delivering your molecule into clinical trials with confidence.

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Clinical Drug Development

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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 Development Services

Fast-track your pipeline with FreeThink’s end-to-end API development services. Our scientists expertly guide API programs for new chemical entities (NCEs) and 505(b)(2) repurposed drug pathways. From early-stage characterization to GMP-compliant supply, we deliver integrated drug formulation development support that reduces timelines and de-risks your program.

  • Pre-formulation studies: Establish foundational API characterization through precise measurement of solubility, permeability, and pKa parameters
  • Salt form and polymorph screening: Execute rigorous pharmaceutical salt screening and solid-state analysis customized for your API
  • Solubilization expertise: Leverage our specialized capabilities in amorphous solid dispersions, including hot-melt extrusion (HME) and spray-dried dispersions (SDD), to overcome bioavailability challenges
  • API scale-up: Partner with our team for seamless API synthesis scale-up from lab through pilot scale, with clear pathways to commercial production
  • GMP manufacturing: Coordinate reliable GMP API supply through our established manufacturing network, ensuring regulatory compliance at every stage

Click here to watch a video demonstration of ASAPdesign™.

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Drug Development

Preclinical Evaluation, Formulation & CMC Expertise

De-risk and accelerate your drug development program with FreeThink’s comprehensive formulation development and CMC services. Our scientists transform APIs into optimized drug products, guiding your compound through preclinical development with enabling technologies.

  • Analytical method development: Establish and validate methods for purity, potency, dissolution, and stability as essential CMC services for regulatory submissions
  • Formulation development: Efficiently design dosage forms aligned with the Target Product Profile (TPP) using FreeThink’s Accelerated Drug Advancement Process (ADAP) in close collaboration with clients to accelerate drug product development
  • Rapid shelf-life determination: Leverage ASAPprime® software for accurate drug product development timelines and predictive stability data for regulatory filings
  • Preclinical assessment: Execute preclinical development studies, including solubility and stability, to assess appropriate drug product development paths forward

Click to view: “What is ASAPprime®?”

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Drug Product Manufacturing

cGMP Clinical Manufacturing Services

FreeThink specialists deliver drug product manufacturing with uncompromising quality and rigorous controls. From process development through clinical manufacturing and distribution, every stage operates under current GMP standards to produce clinical trial materials with confidence.

     

  • Process development: Adapt formulations and procedures from laboratory to clinical manufacturing scale, ensuring reproducibility across oral solid and injectable dosage forms
  • GMP production: Manufacture drug product clinical supplies, including tablets, capsules, and injectable formulations, with strict quality systems and cGMP manufacturing oversight
  • Packaging and distribution: Package, label, and ship drug product dosages to clinical sites using validated quality systems and controlled logistics, coordinated by dedicated project management
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Regulatory and Clinical Development Services

FreeThink assures regulatory acceptability based on the agreed strategy and organizes clinical operations for efficient first in human (Phase I) clinical trial execution. As your drug development partner, we coordinate every regulatory and clinical milestone to keep your drug development program on track.

 

  • Clinical trial services and strategy: Develop comprehensive strategies for conducting clinical trials, including first in human studies, and hold regulatory meetings with appropriate health authorities to align on the path forward
  • Regulatory documentation: Prepare filings and address queries for the FDA, EMA, and other regulatory agencies, supporting your drug development services with thorough, submission-ready documentation
  • Clinical site management: Identify sites and clinicians, managing contracts and logistics to ensure seamless clinical development operations from activation through closeout
  • Bioanalytical and pharmacokinetic analysis: Identify labs for drug, metabolite, and biomarker analyses, with modeling as needed to support data-driven drug development decisions
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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 drug 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 clinical trials?

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 clinical trial?

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.