Pinnaql strengthens scientific and manufacturing expertise with PRG acquisition.

Engineering compliance. Delivering confidence.

From program strategy to validation and automation, Pinnaql powers your manufacturing operations with technical precision and regulatory clarity.

Manufacturing support that scales with you

In life sciences, manufacturing operations must do more than function; they must prove compliance, adapt to change and protect product quality. As life sciences manufacturing becomes more complex with the increase in therapies and connected devices, collaborating with a partner that can help you navigate these complexities is essential. Pinnaql helps you plan, launch, and manage manufacturing systems that align with global regulations and scale with your production goals.

We bring together engineering, validation, automation, and digital compliance to support the full product lifecycle—from tech transfer to commercial production. Whether you're upgrading equipment, building a new line, or validating MES systems, Pinnaql delivers the structure to ensure SISPQ: Safety, Identity, Strength, Purity, and Quality.

Quality control inspection

End-to-end support for compliant, efficient pharma manufacturing

Our high-value manufacturing solutions drive operational excellence, regulatory readiness, and control across the product lifecycle to deliver safe, effective therapies faster.

01

Program & project management

Expert execution from concept to completion. Accelerate timelines, reduce complexity, and deliver compliant projects with strategic oversight and cross-functional alignment.

02

Engineering & equipment lifecycle

Reliability from design through decommission. Maximize equipment uptime, ensure lifecycle compliance, and reduce total cost of ownership with our engineering-driven approach.

03

CQV & process validation

Validated processes. Confident production. Speed up readiness and stay inspection-ready with risk-based validiation master planning, CQV, and PV solutions.

04

CSV & data integrity compliance

Audit-ready systems built on trust. Mitigate regulatory risk with end-to-end CSV services and robust data integrity aligned to 21 CFR Part 11 and ALCOA+ standards.

Our manufacturing tech operations and lifecycle solutions

Pinnaql supports manufacturing operations with validation, engineering, automation, and project leadership—so you can scale with speed and compliance.
Scientific team meeting

Overview

Strategic manufacturing success starts with disciplined planning and expert oversight. Pinnaql partners with life sciences facilities to lead capital and production initiatives—ensuring regulatory alignment, operational readiness, and flawless execution from initial design through full lifecycle management.

Program & project management

/01

What we do

Capital planning & site strategy

Long-term master planning for infrastructure, investment, and site master planning

Throughput & capacity analysis

Identify bottlenecks and scale production with confidence

Workforce & operational readiness

Align staffing, tech transfer, and training to meet production timelines

Specialized project management

Execution support for drug manufacturing, aseptic fill/finish, combination products, radiopharma, and CGT
Automated vial production

Overview

Manufacturing systems must deliver more than output—they must sustain safety, quality, and adaptability. Pinnaql provides full-spectrum engineering support, helping you manage assets and processes across their lifecycle with regulatory precision and operational foresight.

Engineering, process & equipment lifecycle

/02

What we do

Equipment design & lifecycle management

Custom design, procurement, qualification, and ongoing support for GxP systems

Change management & CAPA

Engineering-led evaluation and execution using TrackWise, MasterControl, and other validated platforms

Investigations & remediation

Root cause analysis, CAPA strategy, and system improvements to reduce compliance risk

Process optimization

Continuous improvement projects using Lean Six Sigma and FMEA to boost efficiency and reduce waste
Pharmaceutical manufacturing equipment

Overview

Pinnaql delivers end-to-end Commissioning, Qualification, and Validation (CQV) services to ensure your facilities, equipment, and processes meet cGMP expectations—efficiently, thoroughly, and in full alignment with FDA, GAMP, and ICHQ standards.

CQV, cleaning & process validation

/03

What we do

Validation master planning

Define scope, timelines, protocols (IQ/OQ/PQ), and documentation strategy.

Cleaning validation

Risk-based validation of CIP/SIP systems and product contact surfaces.

Process validation

Full lifecycle support for aseptic, sterile, and non-sterile manufacturing environments.

Periodic review & requalification

Maintain validated state with structured requalification and documentation updates.
Laboratory quality control operations

Overview

Your digital systems are central to manufacturing and under constant regulatory scrutiny. Pinnaql ensures your MES, SCADA, BAS, and data platforms meet FDA expectations for data integrity, audit trails, and system validation.

CSV, data integrity & 21 CFR Part 11 compliance

/04

What we do

System validation planning & execution

Validation strategies for MES, SCADA, BAS, and other GxP systems—including URS, testing, and reports

ALCOA+ compliance

Ensure records are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available

Audit trail & access controls

Implement secure user roles, electronic signatures, and real-time traceability

Ongoing compliance assurance

Support upgrades, integrations, and revalidation to keep systems inspection-ready

Why Pinnaql for manufacturing operations

Integrated team of engineers, QA, validation, and automation experts.

Deep experience in large molecule, small molecule, and advanced therapies.

Proven experience across batch, continuous, aseptic, and device manufacturing environments.

Scalable support from pilot runs to full commercial production.

Industries we serve

Pharmaceuticals

Advanced therapies

(Biotech, Radiopharma, CGT)

Medical devices

Compounding pharmacies

Ready to optimize your tech operations?

Let’s build compliant, sustainable systems tailored to your lab or manufacturing environment.

Visit us

101 Lindenwood Drive, Suite 225, Malvern, PA 19355

Visit us

9800 Crosspoint Blvd, Suite 200, Indianapolis, IN 46256

Get in touch

(484) 321-3339