Kiel Laboratories helps you move your product forward — faster, smarter, and without wasting budget. Our team knows firsthand how to get to approval, and when you partner with us, you gain direct access to our experts. Through strategic insight and transparent communication, we anticipate and resolve drug product development issues early to keep your timeline on track. Kiel offers flexible non-GMP services to guide you through drug product development with clarity and agility.
Drug Product Services That Move You Forward
We understand every drug product development decision has a downstream impact. Kiel identifies risks early and adjusts when needed to pave a smoother path forward. With support across strategy, formulation, testing, and IP, we help you turn complex development into confident progress.
Product Concept & Strategy
We start by evaluating the viability of your product idea from both a scientific and commercial standpoint. Our team identifies potential risks early and offers proactive solutions so you don’t waste time or money:
- Product concept evaluation: Early checks for feasibility, regulatory challenges, and patient acceptability, including taste and delivery format
- Product development strategy: A flexible development plan with clear go/no-go points and the ability to pivot if issues arise
Formulation & Sourcing
Once we’ve determined the ideal development strategy, we move into the hands-on work of creating a viable, stable formulation:
- Formulation feasibility: Early-stage experiments to test solubility, pH, taste, and potential delivery methods
- Formulation development & stability: Iterative formulation work using real-world and accelerated stability testing protocols to ensure long-term product integrity
- API/excipient sourcing: Vendor vetting based on quality, availability, cost, and future manufacturing needs
Analytical Support
With a working formulation in place, we develop and apply the right testing methods to assess and prepare your product for scale-up, leveraging AI-enabled technologies to adapt more efficiently to necessary changes. Our non-GMP environment allows for quick method development, optimization, and qualification, streamlining method transfer to a cGMP lab for final validation:
- Analytical development: In-house analytical method development services to evaluate potency, impurities, and physical properties
- Analytical testing/assessment: Comprehensive drug stability testing, freeze/thaw studies, light exposure, extractable/leachable, and in-use simulations to uncover issues before clinical or commercial stages
- Compatibility & characterization studies: Assess excipient compatibility, container-closure integrity, and delivery system performance to ensure product reliability
Patent & IP Strategy
We help protect your investment by integrating intellectual property considerations throughout drug product development:
- Patent strategy: Evaluating ways to differentiate your formulation for strong IP positioning
- Landscape search: Conducting FDA filing research to understand what is already on the market
- Freedom to operate assessment: Ensuring you’re not blocked by existing pharmaceutical patent law or exclusivity claims, integrating AI to streamline the process
- Patent drafting: Collaborating closely with patent attorneys to translate technical data into legally sound claims that support your long-term goals
Drug Product Development FAQs
Get clear answers to common questions about drug product development, from early feasibility through formulation, testing, and scale-up.
Drug product development typically progresses through several key stages, each building on the last to reduce risk and prepare for approval:
- Concept evaluation & feasibility: Assess scientific viability, regulatory considerations, and patient acceptability
- Development strategy: Define the regulatory pathway, target product profile, and key milestones
- Formulation development: Create and refine a stable, effective drug product
- Analytical development & testing: Develop methods to assess potency, impurities, and product performance
- Stability & compatibility studies: Evaluate product performance under various storage conditions over time to support shelf-life and packaging decisions
- Scale-up & tech transfer preparation: Prepare for manufacturing and transfer to cGMP environments
Formulation development is central to drug product success because it directly impacts stability, bioavailability, patient acceptability, and manufacturability. Even a promising active ingredient can fail if the formulation does not support consistent delivery or long-term stability. Early formulation decisions also influence analytical requirements, regulatory expectations, and commercial scalability, making this phase essential for reducing risk and avoiding costly rework later in development.
Feasibility evaluation involves assessing whether a product idea is scientifically viable, commercially realistic, and aligned with regulatory expectations. This includes assessing solubility, stability, and delivery options, as well as identifying potential formulation challenges and patient considerations such as taste or ease of use. A strong feasibility assessment also considers the regulatory pathway and potential development risks, helping teams establish clear go/no-go decisions early in the process.
| Challenge | How it can be addressed |
|---|---|
| Formulation instability or poor solubility | Conduct early feasibility studies and iterative formulation development to identify stable compositions |
| Unclear regulatory pathway | Define regulatory strategy early to align development activities with FDA expectations |
| Analytical method limitations | Develop and optimize analytical methods early to ensure accurate, reliable data |
| Scale-up and tech transfer issues | Plan for manufacturability during development to reduce risk during scale-up and transfer to cGMP environments |
| API or excipient sourcing constraints | Vet suppliers early for quality, consistency, and long-term availability |
| Late-stage quality or compliance gaps | Implement phase-appropriate quality systems from the start |
See how Kiel Laboratories’ problem-solving capabilities in action.
Analytical testing during drug product development is used to evaluate the safety, quality, and performance of a formulation.
This typically includes:
- Potency and impurity testing
- Physical characterization
- Stability studies
Additional studies, such as extractables and leachables, compatibility testing, and in-use simulations, help identify potential risks before clinical or commercial stages and ensure the product is ready for cGMP scale-up and regulatory submission.
Kiel helps accelerate timelines by identifying and addressing potential issues early, before they lead to delays or rework. Through integrated support across strategy, formulation, analytical development, and regulatory considerations, the team ensures that decisions made during development align with downstream requirements. Kiel’s flexible, non-GMP environment also allows for rapid method development and iteration, helping clients move efficiently from concept through preparation for cGMP scale-up and regulatory submission.
Leverage Our Pharmaceutical Experience
Whether you’re evaluating a new concept or preparing to scale, Kiel brings practical drug product development experience and insight to help you move forward with fewer surprises and more confidence.