Achieve Quality Compliance in the Pharmaceutical Industry with Pharmatech Associates

It means building only the quality infrastructure your program needs at its current stage—clinical, late-stage, or commercial—then expanding it as you advance. A pre-commercial startup shouldn’t carry the same QMS overhead as a full commercial manufacturer. We right-size your systems so you stay compliant without slowing down or overspending, then scale them as your pipeline matures.

We build defensible, auditable, and repeatable processes across your operation, then pressure-test them through audits and assessments so nothing surprises you during an inspection. That includes reviewing your deviation and Corrective and Preventive Action (CAPA) systems, change control, training records, and data integrity controls—the areas regulators scrutinize most closely.

Yes. We manage the full lifecycle—requirements definition, vendor selection, integration oversight, and computer system validation—so your digital quality, laboratory, and manufacturing systems are validated, connected, and audit-ready rather than siloed and manual.

A Contamination Control Strategy is a documented, holistic plan describing how your facility, processes, and pharma manufacturing controls work together to prevent contamination. Regulators increasingly expect one, particularly for sterile and biologic products. We help you develop and implement a strategy tailored to your specific operation and product profile.

Data integrity underpins every compliant quality system. We assess your systems and controls against ALCOA+ principles, close gaps in how data is created, recorded, and retained, and ensure your electronic systems are validated to protect it—so the data behind your filings is trustworthy and your pharmaceutical quality control practices hold up under review.

Yes. Alongside GMP frameworks and ICH guidance, we help clients align their quality management systems with recognized standards such as ISO 9000, ensuring quality control practices meet both regulatory and market expectations across your target geographies.

A gap assessment measures your current systems against regulatory requirements—21 CFR Part 210/211, ICH Q10, and applicable market standards—to show exactly where you fall short before an inspector does. It’s often the fastest way to establish a baseline for quality compliance in the pharmaceutical industry and to prioritize remediation where the risk is highest. We deliver a clear, ranked roadmap, not just a list of findings.

Yes. We conduct FDA mock inspections and mock PAI inspections structured around the FDA Six Systems, so your team practices under realistic conditions. We stress-test your investigations, documentation, and responses the way an agency would—turning inspections from a source of anxiety into a rehearsed, defensible process.

We build risk management into your quality system rather than bolting it on—applying ICH Q10 principles to focus resources where product and patient risk are greatest. This keeps compliance and quality proportionate to your stage, from Phase 2 and 3 drug development through commercial pharma manufacturing, and prevents over-engineering low-risk areas.

Yes. We perform internal audits and supplier audits as part of ongoing audits and assessments, and support supplier due diligence during selection or in-licensing. Strong supplier oversight is central to pharmaceutical compliance—weak links upstream become your findings downstream.

Alongside drug and biologic work, we help clients meet QMSR and ISO 13485 requirements. Whether your foundation is ISO 9000, ISO 13485, or GMP, we align your quality control practices to the standards your markets and products demand.

We’re built to move fast. In many cases, we can begin within days—and we can get you on a call with an expert within hours of connecting with us.