Solutions for pharma, biotech, and medical device leaders

Elevating Compliance. Empowering Innovation.

We work alongside pharma, biotech, and medical device companies to navigate lab and manufacturing challenges with precision, speed, and unwavering compliance. Pinnaql delivers reliable results—so you can stay focused on driving innovation, pursuing growth and improving patient lives.

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Glass beakers with clear liquid on a lab bench

The life sciences industry is complex. We simplify it.

The life sciences industry operates in one of the world's most complex and regulated environments, where GxP standards like GMP, GLP, and GEP are non-negotiable. Companies need a partner who understands the science and the systems as the industry evolves with automation, advanced therapies, and increasing regulatory scrutiny. Pinnaql brings deep expertise across pharmaceuticals, biotech, radiopharma, CGT, medical devices, CDMOs, and compounding pharmacies—ensuring quality, accelerating timelines, and driving innovation at every product lifecycle stage.

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Stages in the life of the science industry

Let's transform complexity into confidence

Partner with Pinnaql to navigate the intricate path from development to commercialization with precision and speed. Whether scaling operations, responding to regulatory demands, or modernizing critical systems, our embedded experts deliver the technical and compliance solutions you need—exactly when you need them.

Enhance quality & compliance

Meet rigorous regulatory standards while improving product consistency and audit readiness.

Optimize efficiency

Streamline technical processes, reduce costs, and accelerate your path to market.

Drive innovation

Integrate automation, digital tools, and a culture of continuous improvement.

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Industries served

We provide specialized expertise for every phase of the life sciences journey

Pinnaql delivers hands-on, specialized support across every critical stage of your product lifecycle—from quality systems development and laboratory operations to validation, automation, and manufacturing execution. Our technical experts integrate seamlessly with your team, solving complex regulatory and operational challenges.

Quality systems & lifecycle solutions

Build a foundation of compliance with tailored Quality Management Systems that streamline operations while satisfying regulatory requirements.

Core services:

QMS Development & Implementation.
Regulatory Compliance & Audit Support.
Electronic Quality Management Systems (eQMS).
Expert Witness Services.

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Quality operations & assurance

Transform quality from a compliance exercise into a strategic advantage with robust operational controls and validation frameworks.

Core services:

Change Management Solutions.
SOPs, CAPA, & Deviation Management.
Commissioning, Qualification, and Validation (CQV).
Computer System Validation (CSV) & Digital Validation.

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Lab technical operations & lifecycle services

Maximize laboratory efficiency while ensuring data integrity and compliance across all analytical systems and instruments.

Core services:

Equipment Management & Validation (HPLC, Centrifuges, Chromatography, etc.).
Business Process Outsourcing (BPO) for Lab Management & Compliance.
LIMS Support & Data Integrity Compliance.
CSV & 21 CFR Part 11 Compliance.

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Manufacturing technical operations & lifecycle services

Accelerate manufacturing readiness and maintain cGMP compliance through specialized engineering and validation support.

Core services:

Program & Project Management.
Engineering, Process, Equipment & Lifecycle Management.
CQV, Process, Cleaning, & Equipment Validation.
Automation, Robotics, & Digital Transformation.

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From lab development to manufacturing

Across the life science industry, Pinnaql delivers solutions that span the most critical steps of your product lifecycle from lab operations to tech transfer and manufacturing support.

Development & Formulation

Scale-Up & Tech Transfer

Manufacturing Optimization

Quality Systems & Validation

Post-Approval & Continuous Improvement

End-to-end expertise across your product lifecycle.

Our experienced team provides immediate and impactful solutions by leveraging our extensive expertise in project management, quality systems, compliance, lab asset lifecycle management, automation, and manufacturing engineering/validation.

Partner with Pinnaql to:

Enhance Quality and Compliance: Meet stringent regulatory requirements and ensure product quality.
Optimize Efficiency: Streamline processes, reduce costs, and accelerate time-to-market.
Drive Innovation: Foster a culture of continuous improvement and innovation.

We build quality and compliance into your foundation, managing laboratory environments through comprehensive asset lifecycle management. Our experts handle everything from strategic laboratory start-ups & relocations to equipment installation, qualification and validation, computer system validation, periodic reviews, and change management allowing your scientists to focus on innovation.

We help navigate the critical transition from lab to production, minimizing risk through specialized process and analytical Transfer expertise. Our technical teams ensure scalability, compliance readiness, and documentation integrity at every step, preventing costly delays and regulatory concerns so you can meet your product launch and market demands.

We optimize your production environment with specialized Engineering and Compliance Support, ensuring cGMP alignment through expert Commissioning, Qualification, Validation (CQV), Automation, and Project Management. Our integrated approach protects product quality while maximizing operational efficiency.

Comprehensive lifecycle solutions for each stage of development and manufacturing

Ready to solve compliance challenges? Let's talk.

Our experts are ready to discuss your specific challenges-whether you're navigating a critical launch, modernizing your systems, or streamlining your quality systems.

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Industries served

Industries we serve

Pharmaceuticals

Advanced therapies

Medical Devices

CDMOs

Compounding pharmacies

Pharmaceuticals

Advanced therapies

Medical Devices

CDMOs

Compounding pharmacies

Comprehensive support for small and large molecule manufacturing, including aseptic processing, packaging, and serialization—built for regulatory rigor and operational excellence.

Specialized solutions for Biotech, Radiopharma, and CGT, supporting complex development, sterile production, and evolving GMP compliance standards.

Automated assembly, cleanroom packaging, and combination product validation to meet the highest standards in device manufacturing and FDA/EU compliance.

From formulation to scale-up, we empower CDMOs with integrated lab, engineering, and compliance expertise to accelerate development and ensure GMP readiness.

Tailored services for 503A and 503B facilities, including QMS development, sterile compounding guidance, and full FDA CGMP compliance support.

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The Pinnaql advantage

Integrated expertise delivering cross-functional solutions that are technically sound, inspection-ready, and practical to implement.

Services

Engineering Excellence

Equipment optimization, automation solutions, process validation, and utility systems designed with compliance in mind.

Scientific Expertise

Analytical method development, laboratory system implementation, and seamless technology transfer expertise.

Quality Assurance

Comprehensive regulatory strategy, QMS design, audit preparation, and effective CAPA implementation to ensure compliance.

Integrated Solutions

Our cross-functional teams collaborate to create solutions that are technically sound, compliant, and scalable for your growing business.

Let’s streamline, scale, and solve—together.

Whether you're navigating a system implementation, preparing for an audit, or scaling operations, our team is ready to help. Share a few details, and we’ll connect you with the right experts.