Real Ex-FDA Experts.
Practical Solutions.
Sustainable Results.
Who We Are?
Our Story
Our story began with a passion for helping pharmaceutical and medical device companies navigate the complexities of compliance—differentiating ourselves from large consulting firms by offering a more personalized and hands-on approach. Recognizing the need for specialized expertise, our founder set out to build a company where real ex-FDA experts work directly with clients to craft proactive compliance strategies and deliver sustainable remediation solutions. At PHARMASURE, we prioritize direct, one-on-one interactions, ensuring that every client benefits from the deep, firsthand regulatory knowledge that only former FDA professionals can provide. This unique approach allows us to offer practical, results-driven solutions tailored to each client’s specific needs—delivering the kind of guidance that large, impersonal consulting groups simply can’t match
Founder - Jay Jariwala
Jay Jariwala is a former FDA executive and ex-diplomat with extensive experience in regulatory compliance and enforcement. Prior to founding PHARMASURE, he worked at the U.S. Food and Drug Administration (FDA), where he led over 40 warning letters, 30 import alerts, and numerous regulatory meetings. His tenure at the FDA also included a diplomatic assignment in New Delhi, India, where he managed inspections and policy matters, further enhancing his global perspective on regulatory affairs.
This combination of regulatory expertise and international experience formed the foundation for his subsequent role at Sidley Austin LLP, where Jay helped clients navigate complex regulatory landscapes. His ability to align regulatory compliance with business strategy was critical in developing effective regulatory approaches for companies in the healthcare sector.
Jay is widely recognized for his leadership, strategic vision, and dedication to advancing regulatory practices in the healthcare and life sciences industries. His career has made a lasting impact on shaping compliance frameworks, and he remains a respected figure in the field.
Why PHARMASURE?
At PHARMASURE, we believe that the key to effective compliance and regulatory solutions lies in direct access to real ex-FDA experts. We offer direct interaction with the very person performing the task—someone who has firsthand experience navigating the FDA’s regulatory landscape.
Our approach is built on personalized attention and tailored solutions. We understand that every client’s needs are unique, so we don’t rely on one-size-fits-all strategies. Instead, we work closely with you to develop practical, sustainable compliance plans that are directly aligned with your goals.
At PHARMASURE, you're not just another account—you’re a partner. And when it comes to navigating the complexities of regulatory compliance, there's no substitute for the hands-on expertise and dedicated support of those who have been there themselves.
Ex-FDA Level III Drug Investigator
Ex-FDA Medical Device and Combination Product Investigator
Ex-FDA Level III Drug Investigator
A seasoned pharmaceutical compliance expert, this Ex-FDA Level III Drug Investigator brings over 25 years of experience in FDA oversight. With a Doctor of Pharmacy degree and Level III FDA investigator certification, he has conducted approximately 250 inspections worldwide across sterile, non-sterile, and biotechnology manufacturing facilities. Formerly serving as a Senior Compliance Officer at the FDA, he specializes in pharmaceutical quality auditing, regulatory responses, and inspection readiness. Board Certified in Sterile Compounding, he has also presented internationally on topics related to pharmaceutical regulation.
Ex-FDA/Ex-OMQ Compliance Officer
Ex-FDA Medical Device and Combination Product Investigator
Ex-FDA Level III Drug Investigator
With nearly three decades of federal service, including 24 years with the U.S. Food and Drug Administration (FDA), this consultant brings deep expertise in regulatory compliance, microbiology, and sterile drug manufacturing. Their career spans roles as a Compliance Officer in both the FDA’s Office of Regulatory Affairs and the Center for Drug Evaluation and Research's (CDER) Office of Manufaturing Quality (OMQ), as well as hands-on experience as a microbiologist.
They have led and authored regulatory actions such as warning letters, import alerts, and injunctions, with a focus on high-risk sterile products including parenterals, ophthalmics, and homeopathic drugs. Their technical background covers aseptic processing, sterility assurance, environmental monitoring, water systems, and laboratory operations. Internationally experienced, they participated in inspections across multiple continents and have presented on regulatory microbiology at industry conferences and FDA training events.
Ex-FDA Medical Device and Combination Product Investigator
Ex-FDA Medical Device and Combination Product Investigator
Ex-FDA Medical Device and Combination Product Investigator
A former FDA investigator with specialized experience in medical device inspections, this expert brings a robust regulatory and quality background spanning pharmaceuticals, medical devices, and combination products. Their FDA tenure included oversight of compliance with 21 CFR Parts 210/211, 820, and Part 4, with a focus on QSR and GMP inspections for high-risk products. In industry, they have led global inspection readiness initiatives for a top pharmaceutical company, ensuring successful FDA engagement for complex combination products. With expertise in design controls, risk management, regulatory submissions (IND, NDA, 510(k)), and CAPA systems, they provide strategic compliance support across the full product lifecycle.
Our Services
Inspection Readiness and Unannounced Inspection Simulation
At PHARMASURE, we ensure your company is fully prepared for FDA inspections. Led by ex-FDA experts, our service includes facility audits, document reviews, and mock inspections to identify gaps and develop corrective actions.
Our team is uniquely capable of executing and simulating unannounced inspections in most countries including India and China.
We provide targeted training to help your team navigate inspections smoothly, minimizing risk and ensuring compliance. With PHARMASURE, you’ll approach FDA inspections with confidence.
483 & Warning Letter Response and Remediation Strategy
At PHARMASURE, we specialize in crafting comprehensive responses to FDA 483s and Warning Letters, ensuring not only immediate compliance but also long-term, systemic remediation. Led by ex-FDA experts, our approach goes beyond surface-level fixes—we work closely with your team to identify root causes, implement effective corrective actions, and develop sustainable solutions that address underlying systemic issues. Our goal is to restore compliance and build robust systems that prevent recurrence, helping your organization maintain long-term regulatory readiness and minimize future risk.
Sterile Manufacturing and Aseptic Fill-Finish Assessment
At PHARMASURE, we offer specialized assessments for sterile manufacturing and aseptic fill-finish processes to ensure compliance with FDA standards. Our team of ex-FDA experts conducts thorough evaluations of your facilities, procedures, and equipment, identifying potential risks and areas for improvement. We provide actionable recommendations to enhance sterility assurance, optimize processes, and maintain the highest quality standards.
Contamination Control Strategy (CCS / Annex I)
At PHARMASURE, we provide expert guidance in developing and implementing effective Contamination Control Strategies (CCS) that align with EU Annex I requirements. Our team of ex-FDA experts helps assess your facilities, processes, and systems to identify risks and ensure compliance with the current regulatory standards for sterile product manufacturing. We work with you to create tailored, practical CCS plans that enhance product safety and minimize contamination risks, ensuring both regulatory compliance and operational efficiency.
Visual Inspection
At PHARMASURE, we provide a comprehensive end-to-end assessment of your visual inspection processes to ensure full compliance with USP <790> standards, including for difficult-to-inspect products. Our team of ex-FDA experts evaluates every aspect of your systems, procedures, visual inspection equipment, qualification, and training, with a focus on challenging products that require specialized inspection techniques.
Data Integrity Assessment and Remediation
At PHARMASURE, we specialize in Data Integrity assessments that ensure your systems and processes adhere to the highest regulatory standards, including ALCOA++ principles. Our team of ex-FDA experts conducts a comprehensive review of your data management practices, identifying risks and compliance gaps, especially in areas such as electronic records and data security. We then implement tailored remediation strategies to align your operations with ALCOA++—ensuring data is Accurate, Legible, Contemporaneous, Original, and Attributable, along with the additional principles of ALCOA++
Training
At PHARMASURE, we offer comprehensive CGMP (Current Good Manufacturing Practice) training that goes beyond basic compliance to cover critical areas like Data Integrity, Investigations, Visual Inspection, and Out of Specification (OOS) Handling. Delivered by ex-FDA experts, our training is tailored to your team’s needs, ensuring they understand and apply CGMP principles across all aspects of manufacturing, quality control, and compliance.
Expert Witness
At PHARMASURE, we provide expert witness services during arbitration and other legal matters, Led by ex-FDA experts, we deliver objective, in-depth analysis and testimony on complex regulatory issues, including data integrity. Our team’s real-world experience helps clarify technical details, strengthen your case, and support your legal team in navigating disputes.