Injecting Precision into Aseptic Clinical Trial Manufacturing Services

At Pii, we thrive where others hesitate, with sterile clinical trial manufacturing services built to handle complex and niche aseptic projects. With proven expertise and an unwavering commitment to solving the unsolvable, we deliver the sterility and quality your clinical trial materials call for—no ifs or buts.

Breakthroughs Start Here

Our Clinical Trial Manufacturing Services

Benefits

Capabilities

Team up with Pii for:

Regulatory Excellence: Our sterile clinical trial manufacturing experts stay ahead of regulatory hurdles.
Tackling Complexity: From complex formulations to DEA-controlled substances, we specialize in tackling what others can’t.
Precision Perfected: Our Quality by Design (QbD) approach ensures manufacturing excellence—always accurate and on time.
End-to-End Support: We deliver robust process development and seamless tech transfer, driving success from preclinical through commercial.

Our comprehensive clinical trial manufacturing services leave nothing to chance. Partner with us for:

Specialized Product Handling: Light-sensitive, oxygen-sensitive, highly-potent, or just difficult to make? We have it covered.
Guaranteed Sterility: Product safety is at our core, from aseptic handling to terminal sterilization.
CMC Support: Transparent, expert guidance to ensure smooth submissions and faster progress for your complex aseptic products.
The Whole Package: Including formulation, manufacturing, and compliant packaging and labeling.

Quality Without Compromise

The stakes are too high for anything less than top-notch quality, so you can trust that your aseptic project is in safe, experienced hands. From on-site analytical testing to robotic filling, our QbD approach ensures your clinical trial manufacturing is done right.

Our Quality Assurance

US-based facilities, including 70+ GMP suites.

Inspected and approved by the FDA, EMA, and other regulatory bodies.

DEA-controlled substances and
Safebridge® (OEB 1-4) certified.

Focused on exceeding cGMP standards at every stage.

30+

years of experience in clinical trial manufacturing services

300+

highly trained scientists and support staff

90%

of clients agree we delivered effective solutions

Small Batches for Big Breakthroughs

We manage every stage of sterile clinical trial manufacturing with precision, no matter how unique your project. From pre-formulation studies and formulation development to manufacturing scale-up, pilot batches, and registration studies, you’re in safe hands.

Equipped with specialized fill-finish technology for small trial batches, validated storage, and a QbD approach, we ensure quality across analytical method development, API/excipient testing, and stability studies—all delivered on time, every time.

Mechanical Precision for Aseptic Filling

Don’t waste a drop with our state-of-the-art filling technology. These high-speed, high-precision systems handle vials, syringes, and cartridges, providing on-point aseptic fill-finish for clinical trial manufacturing.

M&O Perry

AST GENiSYS® R20

Complex Challenges, Comprehensive Solutions

Get clinical trial manufacturing services you can count on—always efficient, safe, and tailored to your project.

Complex Formulations: Expert handling of viscous, potent, sensitive, and controlled-release products.
Injectable Expertise: Diverse delivery systems supported by automated aseptic filling—no batch too big or small.
Drug Product Optimization: Processes that enhance stability and bioavailability, including lyophilization, spray drying, particle milling, and vacuum homogenization.

Got Questions?

We have the answers! Transparency is our foundation. Reach out—we’re always happy to tackle your complex and unique aseptic needs.

Let’s Talk

Tech Transfer Done Right

When it comes to aseptic clinical trial manufacturing services, synchronizing production with study timelines is non-negotiable. So, in an industry where timelines shift, and regulations evolve, flexibility is our superpower.

We make tech transfer seamless—starting with a deep understanding of your product and ensuring a headache-free transition to our GMP-certified facilities.

With a knack for tackling what others can’t and a non-negotiable stance on quality, we deliver the precision, sterility, and expertise your clinical trial demands.