Speed Without Shortcuts
Our Molecule-to-Clinic process typically shaves months off the process used by traditional vendors. We achieve this through the efficient use of the latest scientific methodologies along with coordinated project management and parallel development activities, not by cutting corners on generating the data needed for regulatory compliance. For example, formulation development for tablets typically completes in about two months, with clinical manufacturing, packaging, labeling, and shipment to clinical sites taking approximately four months.
One Partner, Complete Solution
Instead of managing relationships with separate API development, formulation, manufacturing, and regulatory vendors, you work with one integrated team. This eliminates coordination delays and communication gaps that can derail startup timelines.
Startup-Focused Pricing
We understand startup budgets. Our integrated approach actually costs less than coordinating multiple vendors while delivering faster results.
Our Integrated API Development Process
Our first efforts often focus on comprehensive API characterization including solubility, permeability, and stability screening. We also evaluate salt forms and polymorphs using pharmaceutical best practices, then assess critical properties for formulation planning.
FreeThink scientists expertly support development of new chemical entities (NCEs) and 505(b)(2) pathways for repurposed drugs, ensuring comprehensive and efficient process completion.
For challenging APIs requiring enhanced bioavailability, we evaluate such technologies as amorphous solid dispersions (ASDs) using spray drying or hot-melt extrusion, self-emulsifying drug delivery systems (SEDDS), and other solubilization strategies.
We also have extensive experience in controlled release technologies for both oral and injectable applications, including our proprietary OzmoCAP® osmotic controlled-release capsule technology.
As the API form is chosen, we coordinate GMP manufacturing with qualified partners while preparing technology transfer documentation and planning the supply chain for clinical trials.
Preclinical Development That Accelerates Clinical Entry
Formulation Development Using ADAP
Our Accelerated Drug Advancement Process (ADAP) combines rapid formulation screening with our proprietary ASAPprime® stability software. While competitors often carry out excipient compatibility studies and then begin formulation work, our tiered formulation strategy takes the formulation process from months down to weeks, in most cases. This is game-changing for start-ups, allowing drug product manufacturing to begin much earlier and helps us get molecules into clinical trials in a much shorter timeframe.
ASAPprime® studies provide remarkably accurate stability results in as little as four weeks and have successfully been used in many regulatory filings worldwide.
Analytical Method Development
We establish FDA-compliant analytical methods early in development, including release testing procedures, stability-indicating assays, and dissolution methods. This parallel approach eliminates the traditional bottlenecks that delay clinical entry.
Clinical Development Support
Regulatory Strategy
Our regulatory team helps navigate FDA requirements through IND application preparation and submission, clinical protocol development, manufacturing documentation for the CMC section, and FDA meeting preparation and follow-up. We prepare filings and address queries for the FDA, EMA, and other regulatory agencies.
Clinical Manufacturing
We handle GMP production of clinical trial materials, packaging and labeling for clinical sites, supply chain management and distribution, plus all quality documentation and batch records. This end-to-end approach ensures consistency and eliminates vendor coordination headaches.
Why Our ASAPprime® Technology Changes Everything
Traditional stability testing requires 3-12 months of real-time studies. Our proprietary ASAPprime® software provides accurate, regulatory agency-accepted shelf-life determinations in 2-4 weeks using accelerated conditions.
For startups, this breakthrough technology enables faster formulation optimization, earlier manufacturing planning, reduced development costs, and quicker investor milestones. It’s the difference between waiting months for answers and getting them in weeks.
A range of scientifically and statistically designed exposure conditions are used to identify the boundaries of product stability. Using these data points, the software projects long-term storage shelf-life based on short-term data eliminating the need for lengthy package screening studies.
Contract Research Organization Expertise
As a specialized pharmaceutical CRO, we understand the regulatory landscape and quality requirements that can trip up inexperienced teams. Our scientists have developed hundreds of drug products and successfully navigated FDA submissions across multiple therapeutic areas. FreeThink was founded in 2011 by Dr. Kenneth Waterman, an AAPS Fellow and author of over 75 publications and patents, after careers at Pfizer and Polaroid. Our scientific leadership team includes veterans from Pfizer, Boehringer Ingelheim, Thermo Fisher, and other major pharmaceutical organizations.
Getting Started: What to Expect
- The initial consultation in week one includes a feasibility assessment of your drug candidate, development timeline and budget estimation, plus risk identification and mitigation strategies.
- Project initiation in weeks 2-3 involves API shipment and characterization beginning, dedicated project manager assignment, and weekly progress reporting establishment.
- The rapid development phase in months 1-4 features parallel API and formulation development, real-time problem-solving and decision-making, and continuous regulatory consultation.
- Clinical preparation in months 5-9 encompasses GMP manufacturing and quality documentation, IND preparation and submission, and clinical trial logistics coordination.
After a drug product is dosed in clinical trials, FreeThink coordinates the bioanalysis of blood samples to establish pharmacokinetics, including key metabolites and biomarkers where available. In many cases, Phase I can be quickly followed by a Phase II trial, potentially using the same dosage supplies. If the product advances into Phase III and commercialization, we facilitate technology transfer of manufacturing operations to an appropriate CMO.
Small Molecule Development Expertise
We specialize in small molecule development across diverse therapeutic areas including oncology compounds with rapid transition from phase I to commercial, pediatric formulations with palatability requirements, and fixed-dose combinations with stability challenges. Drug products include oral solids (tablets, capsules, powders for suspension) and injectable formulations. FreeThink is licensed to handle controlled substances.
The Bottom Line for Startups
Choosing the right drug development partner can make or break your startup. With limited resources and tight timelines, you need a CRO that combines scientific excellence with startup-friendly speed and pricing.
FreeThink’s integrated Molecule-to-Clinic approach delivers faster timelines compared to traditional multi-vendor approaches, lower costs through vendor consolidation, higher success rates with regulatory submissions, dedicated support from PhD-level scientists, and a proven track record with startup clients.
The biotech industry is challenging enough without adding unnecessary complexity to your development process. Our integrated approach simplifies everything while maintaining the highest scientific standards, giving you the best shot at clinical and commercial success.
Ready to accelerate your drug candidate development? Contact FreeThink to discuss your specific program and timeline requirements.
About FreeThink Technologies
FreeThink Technologies is a contract research organization specializing in accelerated drug development services. Our Molecule-to-Clinic platform integrates API development, preclinical development, clinical manufacturing, and regulatory strategy to help pharmaceutical companies advance drug candidates efficiently.
Founded in 2011, FreeThink’s Branford, Connecticut laboratories conduct experimental work to help companies develop formulations, establish analytical methods, and solve complex problems. FreeThink also develops and licenses ASAPprime®, the leading stability software package for determining shelf life under highly accelerated conditions.
Contact: info@freethinktech.com | +1 860 237 5800 | freethinktech.com
Services: API Development | Drug Development Services | Preclinical Development | Clinical Manufacturing | Pharmaceutical Research | GMP Manufacturing