CONSULTING SERVICES

With over 35 years’ experience in both the pharmaceutical and biologics industries, I am determined to provide you with the best pharmaceutical consulting services available, that are tailored to your company’s needs. Drawing on a wealth of industry experience, regulatory awareness, and ambition to help organizations improve their performance, my degree of flexibility can provide a tested means of addressing regulatory issues, correcting operating inefficiencies and activating quality systems. My solutions are practical and sustainable while ensuring compliance and costs eases including business growth.

As a leading pharmaceutical consultant, my role is to work together with quality units, operations, and organizations to spot risk, reduce risk, and create improved processes with resilient quality systems that will be able to pass any kind of regulatory audit. I know that each business has its specificity, and it is possible that what is good for one company is not good for another company, so my pharmaceutical consulting company is highly tailored. My objective is not only to address today’s problems, but also to establish a lasting culture of quality system and a model for future achievement.

Areas of Expertise

Quality Systems Auditing & Remediation: Reliable quality systems are the basis of compliance. I perform cGMP audits and assess the current state and practices to source out causes of non-compliance through intense quality systems consulting. As well as develop and implement corrective and preventive actions (CAPAs) that effectively comply with FDA, EMA, and globally accepted standards. I provide assurance that your organization not only corrects deficiencies but has also established durable systems to facilitate continual improvement.

Interim Controls: When companies are faced with consent decrees, warning letters, or import prohibitions, there is no time to be lost. A part of my pharmaceutical consulting work is to set up interim controls to allow companies to retain market access as corrective actions are being taken. These involve batch record checks, deviation reviews, backlog elimination, and shop floor control. With a competent pharmaceutical consultant at the helm, businesses under regulatory scrutiny can level out operations even as they strive towards long-term compliance.

Retrospective Reviews of Deviations and OOS’s: Closed deviations and out-of-specification (OOS) findings can indicate risk patterns that need to be corrected. With quality systems consulting, I help companies conduct retrospective reviews to identify compliance risks and determine what improvements can be made. Companies can take those lessons learned in prior investigations and utilize that information to improve their overall compliance position and reduce the likelihood of experiencing the same issues again.

Risk Management & Crisis Resolution: In a highly regulated landscape such as the pharmaceutical industry, crises can develop at any moment and range from product recalls to regulatory investigations. I grounded my practice in risk-based decision-making to address these issues, which provides companies with an opportunity to remediate existing issues while being able to manage long-term impacts and the reality of the issue. Understanding that the uncertainty in crises can have devastating effects on pharmaceutical companies, crisis management capabilities are a large part of my pharmaceutical consulting practice and allows companies to operate with certainty and stability, when it matters the most.

Supply Chain Oversight: A compliant supply chain is required to ensure product quality and patient safety. With pharmaceutical consulting experience, I provide oversight of the entire supply chain, which includes APIs, excipients, raw materials, and third-party manufacturing. I ensure that through auditing and oversight processes cross-organizations can recognize vulnerabilities and vendor compliance and therefore safeguard the supply chain through sound quality systems consulting.

Operational Excellence: Apart from compliance, and have a great culture of quality if they wish to stay competitive. I work with teams to streamline the processes, reduce waste, and create a culture of accountability and continuous improvement. My pharmaceutical consulting services improves compliance, but also prepares organisations for success and continuous excellence from an operational and regulatory perspective.

Why Partner with Me?

Choosing the appropriate pharmaceutical consultant could be the difference between patching up and true transformation. My experience as a subject-matter expert in the pharmaceutical and biologics industries spans decades, which means I have both subject-matter expertise and practical experience. I work with your team closely, never in isolation to ensure solutions are actionable, measurable, and contextualized to your objectives.

By hiring my pharmaceutical consulting services, organizations get an ally who is familiar with the complexity of regulatory frameworks but also has awareness of operational imperatives. Clients value not only the technical deliverables of my services but also the enduring improvement in culture, effectiveness, and regulatory confidence.

Whether you require high-level quality systems consulting to improve compliance; crisis management to help address an FDA issue; or full-service assistance to improve the monitoring of your supply chain, I am aligned with you and create results that last.