Advance Small Molecule Drug Development with Pharmatech Associates

It runs from selection and API development through formulation, analytical method development, scale-up, validation, and filing. Each stage produces decisions that constrain the next. The synthetic route determines your impurity profile. Your impurity profile determines your specifications. Your specifications determine what you can defend at review and what your manufacturing process has to deliver every batch. Programs that treat these as one connected strategy move faster than programs that treat them as sequential handoffs.

Earlier than most teams expect. Route, material sourcing, and analytical decisions made in early development determine what you can defend later. Bringing strategy in early costs far less than reworking a program after a filing stalls. If you’re already further along, a focused gap analysis will tell you where you stand and what has to close before your next milestone.

Yes. We support generic sponsors and 505(b)(2) applicants on CMC strategy, bioequivalence documentation, specification justification, and the data package that has to hold up under review. We also help sponsors understand which pathway their program actually fits before they commit to one.

Ex-US programs often need meaningful adaptation before they’re ready for US submission—differences in specification expectations, impurity qualification, stability design, and data presentation are common. We assess your existing package against FDA expectations, identify what has to be generated or reworked, and build the submission strategy from there.

We start with the synthetic route, because that’s where the impurity profile originates. From there we work through identification, qualification, and control—including genotoxic and elemental impurities—and build specifications you can justify with data rather than defend with argument. Impurity strategy is one of the most common sources of late-stage findings in small molecule programs, and one of the most preventable.

Yes. We investigate root cause, design corrective actions that satisfy regulators, and help you return to stable supply. In one case, a client losing 10 percent of batches annually to dissolution failures had root cause identified within six weeks and the product back on market after an 18-month absence.

We manage the technical risk, not just the logistics. That includes gap analysis, risk assessments, protocol and batch record authoring, method transfer, comparability planning, and oversight of readiness activities at the receiving site. We’ve transferred programs across sites and organizations without losing regulatory alignment or schedule.

Yes. Supplier and data integrity issues surface at the worst possible times—during inspection, or after a filing is already under review. We support supplier qualification, technical oversight, audit readiness, and data integrity assessment across your external network.

In silico modeling uses computational simulation to predict how your process will behave under different conditions. It helps you define design spaces, identify critical process parameters, and predict performance—often replacing experiments that would consume months of lab time and material. It’s especially useful in process development, scale-up, and investigating manufacturing performance problems.

A well-built control strategy anticipates change. We help you plan and justify post-approval changes, manage comparability, and implement process improvements without disrupting supply or triggering avoidable regulatory burden.

Both. Our teams cover small molecules, biologics and TIDES, cell and gene therapies, and combination products. We match the right expertise to your product rather than applying a single template.