Our Team

Daniel Dooley

Director of GxP services / Senior Consultant

He is a dedicated and results-driven Quality Expert with over 40 years of experience in the pharmaceutical industry. He has a proven track record of growing business units while successfully implementing and maintaining high standards. Known for his excellent communication skills, he interacts effectively with personnel at all levels across the organization. He possesses a range of skills, including excellent communication, punctuality, reliability, adaptability, attention to detail, and strong team leadership. He holds a National Diploma in Chemical Technology – Applied Chemistry from Cork. His achievements include leading Chemtech Trainers Ltd. and serving as the lead contact for regulatory inspections. His career highlights include over 30 years as Quality Director at Pfizer, 8 years as Global Audit Manager at NorthStar (a McKesson - Fortune 10 US company), and serving as Managing Director of Chemtech Trainers Ltd. As a Quality and Responsible Sourcing (Social Accountability/Supplier Sustainability) auditor, he extensively travelled to several countries and played a key role in improving sites' CGMP and Responsible Sourcing practices. In his role as a Global Audit Manager at NorthStar Healthcare, he conducted cGMP Quality and Responsible Sourcing audits of several hundred supplier sites globally, including in Europe, the United States, Canada, China, and India. He audited various dosage forms, such as oral solid doses, over-the-counter medicines, creams, liquids, ointments, medical devices, and hormonal treatments. He collaborated with CMOs to ensure compliance with the latest FDA guidelines and regulations, provided advice on remediation CAPA for inspection and audit observations, and managed Quality/Technical Agreements.

Dr John Folan

Qualified Person (EU) / Senior Consultant

A highly motivated and accomplished former Senior Director of Quality/Qualified Person (QP) with extensive experience in sterile manufacturing (>25 years), regulatory compliance, and quality management systems. Renowned for exceptional communication and interpersonal skills, adept at fostering effective collaborations both internally and externally. Demonstrates a robust understanding of quality management principles, lean philosophy, analytical thinking, and commercial awareness, driving continuous improvement to ensure the production of high-quality products. He holds a Post Graduate Diploma in Pharmaceutical Manufacturing Technology (QP course) from Trinity college and a PhD degree in Biochemistry from National University, Galway. Boasting significant experience in hosting sterile site audits by major regulatory bodies, including the US FDA, Anvisa, and HPRA, as well as ISO 13485/MDD inspections by notified bodies and certified approximately a thousand batches for sterile dosage forms for the EU and US. Exhibits exemplary project management abilities, successfully overseeing multiple projects simultaneously and ensuring timely completion. Proficient in new facility design, validation, and new product introduction. With a distinguished career spanning various senior roles across leading pharmaceutical companies, excels in designing, maintaining, and enhancing site quality management systems, leading cross- functional teams, and navigating complex regulatory landscapes. A proactive problem solver committed to driving quality excellence and operational efficiency through strong leadership, strategic vision, and comprehensive quality management practices.

Puneet Kumar

Qualified person (U.K.) / Senior Consultant

With over 40 years of extensive experience in the pharmaceutical industry, he has established himself as a highly qualified and recognized expert in various functional areas. As a Qualified Person under the permanent provisions of 2001/83/EC (MHRA Person Number 2443205), he has a deep understanding of pharmaceutical sciences and compliance monitoring. Throughout his career, he has successfully overseen MHRA GMP inspections, hosted US FDA inspections, and certified over 3,000 batches for various dosage forms across more than 55 countries. He has performed over 140 audits globally and serves as a Compliance Monitor (CM) in the MHRA’s pilot Compliance Monitor programme for GMP/GDP remediation supervision. His expertise spans GMP and GDP auditing, batch certification, parallel import procedures, and mentoring and training individuals in the industry. He holds a Post Graduate Diploma with Merit in Industrial Pharmaceutical Studies from the University of Brighton and has received extensive training and certifications from esteemed institutions such as University College London and Hammersmith Medicines Research London. His work experience includes serving as a Head of Quality and Qualified Person for several renowned pharmaceutical companies, including Esteve Pharmaceuticals Limited and Waymade PLC. He is also a Principal Consultant and Contract QP at QNAV Limited, where he provides specialist pharma consultancy services, including global GMP/GDP auditing, batch certification, GMDP training, and project management. As a dedicated professional, he is committed to ensuring the highest standards of quality and compliance in the pharmaceutical industry.

QA & Regulatory Specialists

Our QA & Regulatory specialists specialized in Quality Assurance (QA), Regulatory Affairs (RA), and Responsible Sourcing for the pharmaceutical industry. Our experts ensure compliance with EMA, FDA, MHRA, and ICH guidelines, conducting GMP audits, regulatory submissions, supplier qualification, QMS implementation, and CAPA management. We support batch record reviews, APQR preparation and review, stability studies review, and post-marketing surveillance across biologics, sterile injectables, and other dosage forms. Additionally, we promote ethical and sustainable sourcing by ensuring supply chain transparency, GDP compliance, ESG adherence, and counterfeit prevention. Partner with us to uphold regulatory excellence and responsible procurement in the pharmaceutical industry.