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Quality Assurance Without Compromise

Get tailored, phase-appropriate quality assurance solutions, no matter how complex your project. Always supporting global regulatory compliance, always transparent—no excuses.
Let’s Talk Quality

Rigorous, Robust, and Designed for You

Quality is non-negotiable. Our unwavering commitment to exceeding cGMP requirements through continuous monitoring and process improvement enables us to meet tomorrow's challenges today.

Pii: Where Quality is a Well-Oiled Machine

Custom-engineered quality processes—because no two projects are the same.

Processes that work as hard as we do, optimized for peak efficiency. We know the stakes are too high for wasted time or effort.

Fix it fast, fix it for good. Every issue solved, every recurrence stopped in its tracks—because quality doesn’t compromise.

We don’t rest on “good enough.” Ongoing audits and inspections keep our standards high and your products on point.

Confidence built in. From cGMP to global standards, we deliver compliance you can count on at every phase.

A diagram depicting how Pii quality is a well-oiled machine with the controls and levers colorfully highlighted suggesting a tailored approach.
A diagram depicting how Pii quality is a well-oiled machine with the dials and indicators colorfully highlighted reinforcing process performance.
A diagram depicting how Pii quality is a well-oiled machine with the robot arms and wrenches colorfully highlighted referring to fixing it fast and for good.
A diagram depicting how Pii quality is a well-oiled machine with the conveyor belts colorfully highlighted reflecting Pii's continuous improvement.
A diagram depicting how Pii quality is a well-oiled machine with a 'QC Passed' indicator light and a box labeled 'Pii approved' colorfully highlighted reflecting Pii's regulatory compliance.

Quality Management Systems You Can Trust

Your project is in safe hands. Our integrated electronic quality management software (eQMS)—fully 21 CFR Part 11 and Annex 11 compliant—automates and streamlines quality management. The result? Uncompromising transparency, efficiency, and quality.

MasterControl

MasterControl puts you in control. From document and procedure management to training, this eQMS boosts efficiency with built-in safeguards for seamless process automation and optimization.

TrackWise

Track it all with TrackWise. From deviations to CAPAs, complaints to audits, this agile eQMS enables comprehensive quality oversight with precision, ensuring nothing slips through the cracks.

Pharmaceuticals International Inc President and CEO John Fowler.

“We understand customer requirements and meet those in addition to FDA requirements—we go above and beyond simple compliance.”

Mitch Tse

Head of Quality

100%

FDA Licensed to Produce Commercial Products

4

cGMP Centers of Excellence

70+

GMP suites equipped for precision

2

FEIs for oral and aseptic manufacturing

Where Quality Lives

Beaver Court

80,000 Sq Ft

R&D

Manufacturing

Gilroy Road

72,000 Sq Ft

R&D

Manufacturing

Beaver Dam

52,500 Sq Ft

Raw Materials

Analytical Services

Golden West

72,000 Sq Ft

Analytical Services

Packaging

Beaver Court
103 Beaver Court, Hunt Valley, MD 21030

+1 410-584-0001

A dual-purpose facility specializing in aseptic manufacturing, oral solid dose production, and boasting DEA-compliant vaults to handle controlled substances.
Gilroy Road
10819 Gilroy Road, Hunt Valley, MD 21031

+1 410-584-0001

Dedicated to oral research, development, and manufacturing, this site is well-equipped to produce, warehouse, and ship complex and DEA-controlled oral drugs.
Beaver Dam
10950 Beaver Dam Road, Hunt Valley, MD 21031

+1 410-584-0001

Focused on research and development, this building drives innovation with cutting-edge analytical and quality control labs.
Golden West
10947 Golden West Drive, Hunt Valley, MD 21031

+1 410-584-0001

The hub for packaging, labeling, serialization, and kitting, ensuring product integrity and full traceability from start to finish.
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