JD Quiskeya Enterprises
Validation Engineering & Compliance Consulting Service
JDQE is a specialized consulting firm providing contract services to the pharmaceutical and medical device manufacturing industries regulated by the FDA. Led by a seasoned Senior Consultant with proven expertise in validation, technology transfer, and quality assurance, including Investigations, Supplier Quality and CAPA coordination. JDQE is ready to support projects of all sizes. Our services include staffing projects for the implementation of manufacturing processes, risk analysis, process optimization, and remediation initiatives.
Our Services
Comprehensive support for Pharmaceutical and Medical Device industries, led by a Senior Consultant with proven experience.
Equipment Qualification
- We provide comprehensive equipment qualification services including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Our team develops and executes protocols, implements risk-based validation approaches, and ensures your equipment meets regulatory standards. We also offer requalification strategies and gap assessments to maintain ongoing compliance.
Remediation Activities
- Our remediation services support quality remedial endeavours for regulatory agency audits and responses. We address data integrity, provide audit support, and ensure regulatory inspection readiness. Our team helps update legacy system documentation, close CAPAs, and remediate quality systems to keep your organization inspection-ready and compliant with the latest standards.
Engineering Support
- We offer engineering support for commissioning and qualification (C&Q), project-based contractor deployment, FAT/SAT coordination, and vendor documentation reviews. Our team ensures seamless integration and validation of new and existing equipment and systems.
Quality Assurance Services
- Our QA services include SOP development and revision, QA/QC audit support, change control, deviation investigation, and validation master planning (VMP). We help you build and maintain robust quality systems that support compliance and operational excellence.
About Us
JD Quiskeya Enterprises, Inc. (JDQE) is a specialized consulting partner for the Pharmaceutical and Medical Device industries, led by a Senior Consultant with deep sector expertise.
We provide tailored solutions in Engineering Validation, Compliance, and Project Management, scaling our team to meet your evolving needs. Our experience covers equipment qualification, risk assessments, process validation, technology transfer, investigations, CAPAs, and remediation. We are committed to professionalism, partnership, and delivering results that drive your success.
Serving Critical Sectors
Tailored solutions for the demanding requirements of the pharmaceutical and medical device industries.
Pharmaceuticals
From API manufacturing to finished dosage forms, we ensure the qualification and integrity of your production and laboratory equipment.
- Biologics
- Generics
- Sterile Manufacturing
Medical Devices
Ensuring the compliance and performance of manufacturing, testing, and packaging equipment for all classes of medical devices.
- Class I, II, III Devices
- IVD
- Combination Products
Your Partner for Uncompromising Quality
Experience the difference our specialized approach makes for your critical operations.
Accelerated Compliance
Streamline your validation processes and achieve timely compliance
Reduced Risk
Mitigate regulatory risks and ensure data integrity with our proven methodologies.
Operational Efficiency
Optimize equipment performance and minimize downtime for greater productivity.
Cost Optimization
Strategic remediation and qualification planning to manage your budget effectively.
Expertise & Focus
Leverage deep domain knowledge specific to pharma and med device environments.
Project Management Excellence
End-to-end project management for seamless execution and delivery of validation and compliance initiatives.
Let's Discuss Your Project
We're ready to help you achieve your compliance and operational goals. Reach out for a personalized consultation. Service of Interest Equipment and CSV Qualification/ Remediation/ Investigations/Automation
Join Our Expert Team
Build a rewarding career at the forefront of pharmaceutical and medical device compliance.
We foster a supportive environment where expertise is valued, learning is continuous, and every team member contributes to our clients' success. If you're passionate about quality, compliance, and making a difference, we'd love to hear from you. Reach out to discuss current opportunities or submit your resume for future consideration.
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