Automate with confidence. Scale with intelligence.

From robotics to AI-driven systems, Pinnaql brings regulatory alignment and technical oversight to every step of your automation journey from lab & manufacturing automation to AI-driven compliance solutions

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Smarter systems. Streamlined compliance.

Automation isn’t just about speed—it’s about precision, traceability, and regulatory confidence. Pinnaql delivers automation and digital transformation services that align with FDA, EMA, and global expectations while optimizing process control and operational scalability.

Whether you’re implementing robotics in fill/finish, advanced therapy lab & manufacturing automation, digitizing a batch record process, or rolling out predictive analytics, our cross-functional experts ensure your systems are compliant, validated, and built for long-term performance.

Key benefits of partnering with Pinnaql

We align automation with compliance—so your systems scale smarter, validate faster, and meet global regulatory expectations.

01

Continuous process automation project management

Comprehensive project execution from front-end design through start-up driven by expert automation engineering and lifecycle project management, reducing variability, increasing efficiency, and ensuring compliance.

02

Discrete automation poject management

Engineering-led robust discrete automation solutions from concept to commissioning with detailed project planning, equipment integration, and system delivery aligned to operational goals and GMP standards.

03

Automation validation & regulatory compliance

Turnkey validation strategy development, protocol execution, and documentation fully managed within automation project workflows ensuring audit readiness, GxP compliance, and seamless integration with global pharmaceutical standards.

04

Process automation, robotics & digital transformation

Strategic implementation of digital technologies like advanced robotics, AI, and integrated systems drive innovation, elevate productivity, and enable transformative pharmaceutical manufacturing.

Our automation and digital transformation solutions

Pinnaql supports life sciences teams in planning, deploying, and validating automation systems that meet both operational goals and global regulatory standards.

Sterile manufacturing process monitoring

Overview

From bulk manufacturing to biologics, Pinnaql leads full-lifecycle automation projects for drug substance and drug product operations—ensuring systems are integrated, validated, and regulator-ready.

Program & project management

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What we do

End-to-end project oversight

Planning, design, integration, commissioning, and qualification.

Control system architecture

Design and configuration of PLC, SCADA, and DCS systems aligned with GAMP 5.

Risk & compliance alignment

Perform automation-specific risk assessments and ensure cGMP compliance throughout implementation.

Vendor coordination & FAT/SAT support

Manage technical reviews, documentation, and system handoffs across teams and suppliers.

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Overview

Whether automating filling lines or integrating robotics into packaging and assembly, Pinnaql ensures your discrete automation projects are delivered with compliance, speed, and precision.

Discrete automation project management

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What we do

Deployment planning & execution

Automation strategy for drug product manufacturing, fill/finish, device assembly, and packaging.

System validation & testing

Lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) with full protocol execution.

Cross-functional leadership

Coordinate engineering, QA, and vendors for smooth integration and documentation.

Audit-ready implementation

Ensure every system is backed by traceable validation and regulatory alignment.

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Overview

Validated automation is the foundation of trusted production. Pinnaql builds validation strategies that ensure your automated systems are compliant, reliable, and defensible under global regulatory scrutiny.

Automation validation & regulatory compliance

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What we do

Protocol development & execution:

IQ, OQ, and PQ development tailored to automated platforms and control systems.

Validation and CSV

Apply FMEA and other risk tools and leverage electronic validation platforms to prioritize validation including CSV based on product and patient impact.

Regulatory alignment

Ensure system documentation meets expectations from FDA, EMA, MHRA, and global GxP regulators.

Validation maintenance

Support revalidation and system change control to maintain compliance throughout lifecycle.

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Overview

Digital transformation isn’t optional—it’s strategic. Pinnaql helps life sciences organizations integrate advanced automation, robotics, and AI into validated operations without compromising compliance.

Process automation, robotics & digital transformation

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What we do

Industry 4.0 strategy

Plan and execute digital transformation aligned with GAMP 5 and your product lifecycle.

Ai-driven process control

Implement predictive analytics, real-time monitoring, and adaptive automation systems.

Integrated robotics

Deploy robotic systems in assembly, packaging, and inspection while ensuring traceability and validation.

End-to-end compliance

Align every digital upgrade with FDA, EMA, and global data integrity standards.

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Why Pinnaql for automation & digital transformation

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Cross-functional team with expertise in automation, validation, QA, and data integrity.

Proven success across MES, SCADA, robotics, and AI-enabled systems.

GAMP 5-aligned processes and audit-ready validation documentation.

Trusted by pharma, biotech, CGT, and device manufacturers to bridge compliance and innovation.

Industries we serve

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Pharmaceuticals

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Advanced therapies

(Biotech, Radiopharma, CGT)

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Medical devices

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CDMOs

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Compounding pharmacies

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Ready to leverage advanced technologies to improve operational excellence?

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