Elevate your quality systems. Ensure lifecycle compliance.

We develop and maintain effective Quality Management System frameworks to reduce compliance risks and navigate regulatory complexities throughout your product lifecycle.

GxP compliance for pharma/med device quality excellence

We provide strategic guidance through the intricate landscape of GxP regulations, assisting pharmaceutical and medical device companies in ensuring quality and compliance throughout the product lifecycle. Our cross-functional teams, consisting of quality consultants, engineers, and scientists, possess extensive regulatory knowledge and technical expertise. We focus on the development, implementation, and optimization of quality systems that are not only ready for inspections but also effective in operation.
Medical staff organizing supplies

Key benefits of partnering with Pinnaql

We help life sciences organizations build and maintain strong, compliant quality systems across the product lifecycle.

01

Strategic QMS development

Develop and deploy compliant QMS frameworks that support product safety, efficacy, and consistency.

02

Compliance risk mitigation

Ensure readiness with qualified instruments, validated software, and documented procedures aligned with GLP, GMP, and 21 CFR Part 11.

03

Data integrity & traceability

Maintain reliable operations with consistent equipment and system performance, supported by robust,
audit-ready documentation.

04

Streamlined audit preparation

Present organized, defensible quality records to simplify inspections and reduce regulatory risk.

Our quality systems and lifecycle solutions

Our quality systems solutions are built to align with global regulations while supporting scalability, traceability, and long-term success.
Pharmacist counting prescription pills

Overview

A robust QMS is more than a requirement—it’s essential for product safety, consistency, and compliance. Pinnaql works with pharmaceutical and medical device companies to develop frameworks that align with ISO 13485, cGMP, GLP, and FDA expectations—reducing compliance risk, improving audit outcomes, and strengthening quality across the product lifecycle.

QMS development & implementation

/01

What we do

Tailored QMS design & rollout:

We build frameworks that align with ISO and FDA expectations and support rollout through documentation, training, and team alignment.

Integrated, practical execution

Our systems are grounded in engineering and scientific input to ensure they’re functional across lab and manufacturing.

Ongoing optimization

We support continuous improvement to keep your QMS scalable, compliant, and inspection-ready.
Scientists conducting lab research

Overview

Maintaining compliance in life sciences is complex, with evolving regulations and high stakes. Pinnaql equips your team with proactive compliance strategies and hands-on support during regulatory challenges—strengthening inspection outcomes, preventing future issues, and embedding continuous compliance into your operations.

Regulatory compliance & audit support

/02

What we do

Mock inspections & gap assessments

Identify vulnerabilities through simulated audits and readiness reviews

Compliance program development

Design scalable frameworks for monitoring, training, and quality oversight

Regulatory intelligence & risk mitigation

Monitor regulatory shifts and implement early response strategies

Workforce preparedness

Train staff in compliance expectations and audit protocols

Regulatory response & remediation

Develop strategic responses to FDA 483s, Warning Letters, and enforcement actions, including CAPA plans and SME-guided technical resolution
Futuristic medical technology interface

Overview

Modern quality systems demand digital infrastructure that drives compliance, efficiency, and insight. Pinnaql helps organizations implement eQMS platforms that are compliant, practical, and seamlessly integrated across operations—improving traceability, reducing manual work, and ensuring your compliance infrastructure scales with growth.

Electronic quality management systems (eQMS)

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What we do

System selection & planning

Match eQMS platforms to your operational and regulatory needs, including workflow mapping and vendor evaluation.

Implementation & configuration

Deploy modules for document control, training, CAPA, audit trails, and compliance dashboards—configured for scalability and ease of use.

Data integrity & integration

Ensure 21 CFR Part 11 and GxP alignment through secure system configuration, access control, and audit trail validation.

Cross-functional integration

Align eQMS systems with lab and manufacturing workflows to ensure operational continuity.

Scalability & sustainability

Implement flexible platforms that support continuous improvement and grow with your business.
Scientists analyzing lab data

Overview

When regulatory issues escalate into legal matters, expert insight is critical. Pinnaql provides experienced consultants to serve as expert witnesses and technical advisors. Our experts bring deep industry knowledge and regulatory expertise, ensuring that legal teams and organizations are equipped to handle FDA-related matters effectively. With the backing of experienced engineers and scientists, we offer unique insights that bridge the gap between regulatory compliance and technical feasibility.

Expert witness services

/04

What we do

Expert testimony

Provide objective, credible insight into FDA compliance, regulatory strategy, and industry norms.

Regulatory case analysis

Evaluate records, audit trails, and enforcement actions to support
case development.

Litigation & defense support

Assist with document review, opinion development, and response strategy.

Technical remediation strategy:

Advise on risk mitigation and compliance improvement in response to legal findings.

Why Pinnaql for quality systems & lifecycle solutions

Cross-functional teams of engineers, scientists, and quality consultants

Risk-based strategies tailored for pharma and med device environments

Deep expertise in cGMP, GLP, GEP, ISO 13485, and FDA requirements

Inspection-ready systems built for real-world lab and manufacturing operations

Industries we serve

Pharmaceuticals

Advanced therapies

(Biotech, Radiopharma, CGT)

Medical devices

Compounding pharmacies

Ready to optimize your quality systems?

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