Accelerating analytical method development can significantly shorten drug development timelines and support early process scale-up and validation — but only if high performance and regulatory compliance are maintained. Experic combines deep expertise, advanced technologies, and a QbD-driven approach to deliver robust, phase-appropriate methods that evolve with each program from early development through commercialization.
Navigating the Complexities of Analytical Development
Developing analytical methods that are both robust and adaptable is a cornerstone of pharmaceutical product development, but the process is rarely straightforward. Each method must be tailored to the molecule, the formulation, and the phase of development, with the flexibility to evolve as the program advances from early-phase work to full commercialization. At every step, methods must remain fit-for-purpose while aligning with current regulatory expectations.
In practice, analytical method development must progress in parallel with process development. That synchronicity demands tight coordination between multiple teams, including formulation, production, and quality, and in the case of contract development and manufacturing organizations (CDMOs), between the service provider and its clients. This dynamic can be especially challenging when the client lacks in-house analytical expertise or when formulation changes are still occurring during analytical method validation, potentially introducing delays or requiring reassessment of the method’s suitability.
Layered atop this complexity is the need to meet stringent good manufacturing practice (GMP) requirements for method qualification, validation, and lifecycle management. Method validation today must increasingly incorporate quality-by-design (QbD) principles, which requires defining design space parameters and demonstrating robustness across operating conditions. These evolving regulatory expectations have raised the bar not only for technical rigor but also for documentation.
Documentation can be one of the most significant bottlenecks in analytical development. Industry estimates and internal assessments alike suggest that documentation tasks can consume up to half of an analyst’s time, and any deficiencies can trigger compliance issues or regulatory delays. From method protocols to validation reports and stability data packages, each document must follow specific format and content standards. Even small inconsistencies or omissions can have outsized consequences. As such, managing documentation efficiently while maintaining full compliance is not just a matter of organization — it’s central to avoiding delays and ensuring the overall success of drug development programs.
Faster Methods, Smarter Development
Accelerating analytical method development isn’t just about shaving time off the calendar — it’s about enabling smarter, more agile decision-making at every stage of a drug’s life cycle. When robust methods are developed early and efficiently, they don’t just keep pace with process development, they help guide it.
Streamlined analytical development directly supports earlier process scale-up and validation by ensuring that critical assays are in place when production timelines demand them. In CDMO environments, where production slots are tightly scheduled and revenue is closely tied to on-time delivery, having methods ready for batch release, cleaning verification, and in-process testing is essential. Delays in analytical readiness can quickly cascade into broader project setbacks, jeopardizing client trust and clinical timelines.
Advanced technologies and digital modeling tools dramatically enhance these efficiencies. Faster turnaround of analytical data not only speeds batch disposition but also allows for rapid iteration during formulation or process optimization.
Crucially, accelerated method development also delivers strategic visibility. Early access to well-designed methods enables developers to quickly flag problematic formulations, such as those with poor stability profiles or unexpected degradation pathways, that might otherwise advance too far before issues emerge. This early insight can reduce downstream chemistry, manufacturing, and controls (CMC) risks and avoid costly reformulations or regulatory setbacks late in development.
In this way, speed in analytical development becomes a force multiplier — empowering faster cycles of learning, reducing uncertainty, and enabling more confident decision-making from preclinical studies through commercial readiness.
Building Smarter Methods: QbD and Digital Tools in Action
At Experic, accelerating analytical development isn’t just about working faster; it’s about working smarter. A cornerstone of this approach is the integration of QbD principles into both process and analytical method development. Rather than developing methods through trial-and-error or relying solely on legacy protocols, Experic uses QbD to define a clear design space and systematically evaluate method parameters to ensure robustness, reproducibility, and scalability.
QbD alone isn’t enough; it must be supported by the right digital infrastructure. Experic pairs its QbD-based development with advanced statistical and modeling software that enables rapid design and optimization of analytical methods. Tools such as Fusion QbD software allow the team to simulate and assess the impact of different variables, such as column chemistry, flow rates, or temperature, before conducting physical experiments. This dramatically reduces development timelines and ensures that the methods are not only high-performing but also well-characterized and phase-appropriate from the outset.
In parallel, Experic has invested in streamlining documentation, which is often a hidden time sink in analytical programs. Instead of starting from scratch, analysts use standardized, pre-populated templates for method protocols, validation reports, and stability study documentation. Combined with electronic documentation systems, this strategy reduces human error, increases consistency, and makes review and revision far more efficient, all while maintaining full GMP compliance.
Experic also stays ahead of evolving customer and regulatory needs by continually adopting new instrumentation and analytical technologies. A prime example is the use of ultra-high-performance liquid chromatography (UPLC), which has become a workhorse for high-throughput method development and testing. UPLC enables faster separations with sharper resolution, often cutting assay times from 10 minutes to just one. This is particularly impactful for complex workflows, such as next-generation impactor (NGI) testing of inhaled products, where over 70 samples may be analyzed per run. In such scenarios, switching from high-performance liquid chromatography (HPLC) to UPLC translates into savings of several hours per batch — with downstream benefits for both laboratory throughput and production scheduling.
Experic has also applied UPLC to cleaning verification, where time is especially critical. Faster turnaround in confirming equipment cleanliness allows production teams to proceed confidently with the next manufacturing run, helping to keep the entire operation on track and responsive.
Together, QbD, digital tools, and advanced technologies form the foundation of Experic’s approach to analytical development — one that emphasizes scientific rigor, operational efficiency, and true client partnership.
Moving Fast, Staying Right: Safeguarding Quality While Accelerating
At Experic, speed is never pursued at the expense of precision. Every strategy implemented to accelerate analytical method development is designed with an uncompromising focus on performance, compliance, and risk mitigation.
One of the simplest but most powerful tools in maintaining this balance is the use of structured documentation systems. By linking pre-populated templates to digital data management platforms, Experic minimizes opportunities for error while dramatically improving the efficiency and consistency of method execution and review. These templates embed key parameters and procedural steps, guiding analysts through complex methods while ensuring that all GMP requirements are met.
Recognizing that even the most skilled professionals are not immune to error, Experic designs its systems and workflows to support — rather than strain — human performance. Analytical protocols are crafted to be as intuitive and user-friendly as possible, and instrumentation software is chosen not just for its power but also for its usability. This attention to ergonomics reduces the likelihood of costly mistakes, particularly during routine but critical activities like setting instrument parameters or documenting results.
But risk mitigation at Experic goes beyond tools; it's embedded in the team culture. Analysts receive continuous training on the latest techniques, technologies, and regulatory expectations. Every new method or protocol is thoroughly reviewed before execution, and analysts are encouraged to fully understand the rationale behind each step, not simply follow instructions.
One particularly effective safeguard is Experic’s policy of peer review prior to running an analysis. Before any major analytical procedure is initiated, a second trained analyst reviews the setup, verifying critical parameters like column temperature, flow rate, and injection volume. This brief but essential step has prevented countless issues, from simple typos to misconfigured instruments, that could otherwise lead to deviations, rework, or failed runs.
By combining intelligent systems with expert teams and a culture of diligence, Experic ensures that accelerated timelines do not introduce avoidable risks and that quality remains a shared, daily commitment.
Phase-Appropriate, Tailored Development
Analytical method development is never one-size-fits-all. To be effective, methods must be calibrated to the specific needs of the development phase — flexible and efficient in early stages but increasingly rigorous as the program advances toward regulatory submission and commercialization. Achieving this balance demands not only technical skill but also strategic foresight and a deep understanding of the molecule and formulation involved.
At Experic, every analytical development effort begins with a phase-appropriate mindset. Methods are designed with the candidate’s future in view: adaptable enough to evolve, but robust enough to yield high-confidence data from the start. Because different stages of development carry different regulatory expectations and CMC risk profiles, each project requires a custom-built strategy that integrates formulation stability, release testing needs, and validation readiness.
Drawing on broad experience across dosage forms and modalities, including complex formulations and inhalation products, Experic’s team can quickly determine the most effective starting point for each program. This accelerates development by avoiding unnecessary reinvention and allowing the team to leverage established best practices.
Just as important as technical experience is the culture of collaboration that fuels ongoing innovation. Analysts at Experic regularly share insights from their active projects, including challenges encountered and solutions developed. Through internal forums and presentations, lessons learned by one team member are passed on to others, even those not directly involved. This shared learning environment ensures that the entire analytical group continually evolves, builds institutional knowledge, and applies collective expertise to new problems.
The diversity of Experic’s analytical team is another strategic advantage. Each analyst brings unique training, industry background, and scientific strengths, whether in method innovation, troubleshooting, or repeatable QC execution. Projects are matched to analysts based not only on availability, but on alignment with the technical and interpersonal demands of the work. Some clients require development of novel analytical methods from the ground up; others need targeted support for verification, specification-setting, or stability studies. Some come with highly specific analytical requirements; others look to Experic for scientific and regulatory guidance throughout the program.
This flexibility is central to Experic’s model. Rather than forcing clients into a rigid framework, the team adapts to each sponsor’s capabilities and needs. Whether acting as a hands-on partner in method development or as a seamless extension of the client’s internal team, Experic ensures that every analytical strategy is tuned to both the product and the people behind it.
Transparency as a Tool for Acceleration
At Experic, we believe that successful analytical development is built on a foundation of clear, continuous communication, both within our organization and with our clients. In a complex, fast-moving project environment, staying aligned isn’t a one-time event; it’s a structured, ongoing discipline.
The process begins internally. Before a client conversation ever takes place, cross-functional teams — including formulation, production, quality, and analytics — meet to align on the project’s needs, timelines, and technical approach. This upfront coordination ensures that any plan brought to the client reflects a cohesive and well-considered strategy.
Client discussions follow, focusing on surfacing gaps, clarifying expectations, and tailoring the strategy to the sponsor’s goals. Once feedback is received, Experic reconvenes internally to revise and fine-tune the plan. This iterative approach prevents misalignment, reduces rework, and builds mutual trust from day one.
That alignment isn’t static. In early-phase development especially, change is inevitable, as new clinical data, formulation shifts, or regulatory considerations can all alter analytical priorities. Maintaining continuous contact with the client allows Experic to adapt in real time, ensuring that method development, validation, and specification-setting evolve alongside the product.
Importantly, this communication is not limited to formal updates. Experic’s organizational structure enables clients to easily reach anyone involved in their project, including top management. This accessibility fosters transparency, responsiveness, and a shared sense of ownership. When questions arise or adjustments are needed, answers are never far away.
Equally essential is the understanding that clients often hold data and insights, such as clinical outcomes or evolving target product profiles, to which Experic may not initially have access. Without close collaboration, these critical inputs risk being overlooked. Through regular check-ins, joint problem-solving, and mutual information sharing, Experic ensures that analytical strategies remain aligned with the full picture of the product’s development journey.
This open, proactive model of communication is more than good project management — it’s a competitive advantage. It allows Experic to move faster, respond smarter, and consistently deliver analytical solutions that are both scientifically sound and operationally aligned.