Our Team
Empowering Pharma Innovation with Regulatory Expertise
At XFDA Pharma Advisors, our expert team in pharmaceutical development, commercialization, and global regulatory affairs simplifies complex compliance challenges. We help clients accelerate regulatory submissions, strengthen CGMP compliance, enhance inspection readiness, and bring innovative treatments to patients worldwide. Our proven pharmaceutical consulting approach emphasizes data integrity, effective audits, and robust QMS oversight to ensure sustainable success in highly regulated markets.
With a global network of seasoned consultants, we bring together deep regulatory expertise and real‑world industry insight across diverse markets and therapeutic areas. This collaborative model makes us a trusted partner for organizations worldwide.
Whether advancing early‑stage development, preparing for market entry, or addressing complex regulatory challenges, XFDA Pharma Advisors delivers integrated compliance solutions aligned with strategic goals — strengthening CGMP compliance, enhancing inspection readiness, safeguarding data integrity, and streamlining regulatory submissions. Our risk‑based approach reinforces audits and robust QMS oversight, accelerating compliance, reducing risk, and enabling efficient regulatory success.
About Our Founder:
Deyaa Shaheen
Accomplished senior compliance executive with nearly 30 years of global experience across pharmaceuticals, biopharmaceuticals, and regulatory affairs. Former U.S. FDA Drug Investigator (OII/ORA) and CDER Compliance Officer with a proven record of driving FDA/EMA inspection readiness and sustainable CGMP compliance excellence.
Recognized expert in CGMP compliance, inspection readiness, data integrity, and global health authority enforcement (FDA, EMA, MHRA, Health Canada, PMDA, ANVISA, Swissmedic). Led and supported 50+ FDA pre-approval and surveillance inspections and directed audit programs across 100+ global facilities.
Highly skilled in FDA 483 and Warning Letter response strategy, regulatory meeting preparation, and developing long-term remediation and QMS enhancement plans. Strengthens quality systems, reduces compliance risks, and improves operational performance across internal sites and CMO/CDMO networks. Experience includes CMC and data integrity reviews for NDA, ANDA, and BLA submissions.
Passionate about building a culture of quality, accountability, and patient safety — helping companies anticipate regulatory expectations, close compliance gaps with precision, and achieve successful outcomes with confidence.
Dr. Zhongren Wu
Dr. Wu has served at the FDA for nine years, contributing to both the Office of Regulatory Affairs (ORA) and the Center for Biologics Evaluation and Research (CBER). In his role as a drug inspector and reviewer, he has conducted inspections across a wide range of products—including vaccines, cell therapy drugs, monoclonal antibodies, enzymes, sterile and non-sterile small molecule drugs, active pharmaceutical ingredients (APIs), and compounding facilities—both within the United States and internationally. His areas of expertise span CGMP compliance for facilities and equipment, contamination and cross-contamination control, environmental monitoring, aseptic manufacturing operations, in-process testing, risk assessment, equipment qualification, deviation investigations, document control, and data integrity compliance.
Steven Donald A former FDA Expert
Steven is currently working as a consultant and is assessing drug manufacturing facilities and 503A and 503B pharmacy compounding facilities to help ensure compliance with the regulatory requirements. Prior to this, he worked as a Lead Consumer Safety Officer at the FDA, having worked at the agency for 11 years; his main
focus was aseptic manufacturing. To this end, he assessed aseptic fill procedures and aseptic technique as performed by the manufacturer, as well as the maintenance of the required Class 1 environment. He also reviewed terminal sterilization procedures for products requiring such as well as blow-fill-seal technology. Steve started off as a microbiologist, where he reviewed NDA, ANDA and INDs for sterility assurance methodologies, and then moved into a facility inspector role with the Baltimore District Office then later with the elite FDA Foreign Cadre. He was also responsible for providing training to less senior inspectors on how to perform a wide variety of inspection types, including sterile injectable manufacturing facilities.
Steve has performed at least 65 foreign and domestic inspections, with the majority being aseptic processing or terminal sterilization inspections. He has issued 483 observations and performed follow-up inspections to ensure compliance with warning letter notifications. During team inspections as a lead inspector, he would distribute the
workload for the inspection and quality check other inspectors’ reports.
Before joining the FDA, he gained his understanding of small-scale manufacturing including chemical synthesis, separation technologies and aseptic processing in a basic research laboratory when working as a research biologist. As a professor of microbiology, Steve gained transferable skills in management by lecturing, coaching and developing students by giving constructive feedback.
Dr. Constance Fears, Ph.D. A former FDA Expert
Accomplished Quality and Regulatory professional with extensive experience in FDA, CGMP, GLP, GCP, CLIA, CAP, and ISO compliance across biologics, medical devices, IVDs, and biopharmaceuticals. Proven expertise in quality systems management, regulatory inspection readiness, supplier qualification, data integrity, and risk management.
Strong record of leading multi-site QA/QC operations, developing and validating laboratory protocols, and maintaining compliance with FDA, EU, and ISO standards. Skilled in audit management, CAPA execution, training, QMS/eQMS administration, and regulatory submissions.
Technical background includes advanced proficiency in LC/MS, GC/MS, immunoassays, and analytical validation, supported by a Ph.D. in Pharmaceutical Sciences and a Postdoctoral Fellowship in Onco-metabolomics from MD Anderson Cancer Center.
Recognized for driving inspection readiness, continuous improvement, and global regulatory compliance in complex manufacturing and laboratory environments. Certified ASQ Quality Auditor and Toxicological Chemist with nearly a decade of leadership in GxP compliance, laboratory quality, and regulatory oversight.
Joe Brady, PhD
Passionate and capable bioprocess scientist. Proficiency in design, specification, testing,
operation, and upgrading of process, facility, utility, laboratory, and business systems/
computerised applications. Highly experienced tech transfer consultant, and in process
validation and quality assurance. Qualified and highly experienced pharmaceutical auditor
for CGMP and GDP activities. Advocate of efficient and lean implementation of traceable
science and risk-based design, development, specification, testing, and operational practices
across the product and manufacturing system lifecycles.
Nagesh Voleti
Seasoned pharmaceutical quality and operations leader with over 30 years of global experience driving regulatory compliance, manufacturing excellence, and strategic process improvement. Proven success with top-tier organizations including GSK, Dr. Reddy’s Laboratories, Abbott, Sun Pharma, and Baxter, consistently enhancing product quality, operational efficiency, and regulatory alignment. Skilled in global regulatory audits and compliance (US FDA, MHRA, TGA, ANVISA, MCC), remediation following warning letters and import alerts, quality management system optimization, and performance metrics improvement. Recognized for developing high-performing teams, fostering a culture of continuous improvement, and aligning technical rigor with business strategy to achieve sustainable results. Now seeking to leverage this extensive industry expertise in a senior consulting or leadership role focused on operational transformation, quality excellence, and global compliance.
Manoj Munjal
CGMP Auditor & Pharmaceutical Quality Consultant A highly experienced CGMP auditor and trainer with over 18 years of expertise in pharmaceutical manufacturing (Formulation and API). Specializes in third-party, internal, and gap audits, CGMP training, and implementation of robust Quality Systems for contract manufacturers.
Demonstrated success in ensuring regulatory compliance with USFDA, MHRA, EDQM, WHO, and EU-CGMP requirements through effective audit readiness programs, quality oversight, and investigation management (OOS, OOT, deviations, CAPA). Skilled in data integrity assessments, CSV, and vendor qualification.
Proven track record in project management and digital quality transformation, including deployment of systems such as Labware LIMS, Trackwise, e-DMS, and SAP. Adept at instrument qualification, quality risk management, and continuous improvement initiatives (PDCA, DMAIC).
Recognized for strong analytical ability, regulatory insight, and leadership in driving quality culture and compliance excellence across multiple global sites.
Wim Vanderaerden
Wim Vanderaerden brings over two decades of pharmaceutical manufacturing, operations leadership, and technical quality expertise to his consulting practice. Based in Leuven, Belgium, he has led large-scale sites and multidisciplinary teams across Europe and Russia, overseeing the production of oral solid dosage forms, sterile products, and monoclonal antibodies.
Wim began his career in sterile manufacturing at MSD, advancing through roles in validation, operations, and quality before being appointed Plant Director of the Liquid, Ointment, and Crème facility—managing an annual output of 90 million units along with multimillion-euro budgets and capital projects. Later, as Plant Manager at R-Pharm, he led more than 550 professionals in strategic partnerships with Roche, BMS, MSD, and UCB.
Since 2018, Wim has worked as an independent consultant, advising organizations on manufacturing optimization, regulatory compliance, and operational excellence. Known for his pragmatic and results-driven approach, he integrates technical rigor with leadership insight to enhance quality systems and production efficiency.
Outside of work, Wim enjoys travel, cultural exploration, and time in the Flemish countryside. He is passionate about mentoring future life sciences leaders and advancing global pharmaceutical manufacturing standards.
Joshua O'Daniels
Accomplished scientific leader and Quality Assurance expert with over a decade of experience driving compliance, laboratory excellence, and FDA remediation across global pharmaceutical and biotechnology organizations. Proven success in leading cross-functional teams to implement CGMP, QC, and Lean Six Sigma initiatives that enhance quality, efficiency, and regulatory readiness. Recognized for analytical acumen, strategic problem-solving, and ability to translate complex scientific data into actionable insights for business and regulatory stakeholders. Skilled in chromatographic analysis, data integrity, laboratory operations, and quality systems management across biologics, sterile manufacturing, and small molecule environments.
Carolina Camargo
Regulatory Compliance & Quality Leader | GxP Audit Expert | RAPS Certified
Carolina Camargo is a Regulatory Compliance and Quality Lead with more than 12 years of experience supporting pharmaceutical and biopharmaceutical organisations worldwide. She has successfully led GxP audit programs, strengthened quality management systems, and ensured global inspection readiness with leading health authorities including Swissmedic, FDA, ANVISA, Health Canada, and China NMPA.
Throughout her career, Carolina has held key compliance and quality roles at global companies such as Smith & Nephew, Merck, and KBI Biopharma, where she managed high-profile audits, cross-functional risk programs, and supplier qualification initiatives. She has extensive customer-facing experience in quality agreement negotiation and audit scheduling, ensuring strong partnerships and transparent communication between clients, supplier and regulatory bodies. Her expertise spans both clinical and commercial manufacturing environments, consistently ensuring alignment with international regulatory expectations.
As part of the XFDA consulting team, Carolina brings a pragmatic, solution-driven, and globally minded approach to achieving sustainable compliance and inspection success.
Josette Miceli
Josette Miceli brings 25+ years of pharmaceutical quality leadership with regulatory inspection readiness across FDA, EMA, and MHRA jurisdictions. She specializes in transforming quality organizations from reactive compliance functions into strategic business enablers, delivering measurable outcomes including zero-finding inspections, measurable reductions in deviations, and improved process times. Her expertise spans clinical and commercial pharmaceutical operations, where she has successfully scaled quality systems during periods of exponential growth while maintaining flawless regulatory compliance.
Organizations engage Josette when they need inspection readiness, quality system transformations that reduce costs while improving compliance, or interim executive leadership that bridges technical quality expertise with strategic business acumen. Whether providing strategic guidance to C-suite executives, serving as fractional quality leadership, or rolling up her sleeves to write SOPs, review deviations, lead CAPAs, or conduct gap assessments, Josette adapts her engagement to match organizational needs. She excels at building scalable quality infrastructure and positioning regulatory excellence as competitive advantage, which is particularly valuable for small and mid-sized companies competing through reliability rather than scale.
