Consultwing

From assessing to staff augmentation: We have you covered

Translating complex regulatory requirements into business centric solutions….

With over 35 plus years of global experience in Medical Devices, Pharmaceuticals, Biotech and Combination products, we understand your needs and resource challenges to provide sustainable solutions

Consultants consult, we resolve: By understanding your areas of opportunities, collaboration on alignment of risks and prioritization of improvement areas; we develop the action plan and engagement of the organization for complete resolution.

Regulatoy Compliance and Quality Systems
We focus on developing an integrated process approach for all elements of your Quality System, including providing IT solutions to meet the current and future needs of your organization. Learn more
Patient Safety and Risk Management
We take a process approach; understanding risk management and that protecting the patient is the best way to protect your bottom line. Learn more
Product Life-cycle Management
We specialize in Total Product Life-cycle system development: Concept, Development, Technical Transfer from R&D into Manufacturing, Production, Post-Market Support. Establishing a process approach for proper communications and hand-offs. Learn more
Organizational Agility: Coaching and Mentoring
Over 200 Quality and Regulatory professional through training and provided mentoring oversight to over a dozen Vice President level professionals to enhance their quality, management and process effectiveness skills.

Feedback from customers, who trust in our services

Exceeding customers expectations, delivering sustaining solution

Paul is an excellent resource for Quality Systems (Medical Device and Pharma) knowledge and experience. He has the ability to evaluate a quality system holistically; identifying gaps and providing customer driven solutions in system interactions to improve the robustness of the entire Quality System. His working knowledge of customer interactions, risk management and Pharmacovigilance enables him to translate field issues into solutions, whether at the manufacturing sites or changes in instructions for use. His expertise in design control and in various design control elements has helped improve the design control process for medical device and pharmaceutical products, resulting in expedient product launches. During my tenure with Paul, I have learned that he has great interpersonal skills and works well with people at all levels with the organization, including regulatory agencies.

Rubik

It has been my great pleasure to work with Paul on several critical projects and to get to know him personally. Paul has a deep understanding of quality systems, global regulations, and the medical device development process. He is my “go to” resident expert and his leadership, expertise, and sense of humor are invaluable to quickly resolve challenging issues. Paul is a thoughtful and strategic leader, with a comprehensive view of the organization. Paul leverages his broad business perspective and quality process knowledge to identify gaps and work across organizational boundaries providing solutions to achieve success for the company. This is an incredible strength to bring to any organization.

Elizabeth

I would like to recommend Paul for his outstanding ability to understand pharmacovigilance and quality assurance. Having a background in both areas, he is able to create interfaces between the two groups that work really well, from an operational perspective (which is challenging, given the different nature and objectives of the organizations) and from a scientific perspective in mining pharmacovigilance data to generate meaningful insights into pharmaceutical quality and vice versa (which is even more challenging). I have worked with Paul while at Amgen on a number of interface issues between PV and QA and found him to be not only a very capable scientist and manager but also a very collegial and charming person. His engagement in preparing a pharmacovigilance inspection was critical to the success of this effort, as far as the PV-QC interface was concerned. He did set p a reporting process that aligned the needs of safety and quality and built strong relationships with the safety scientists to evaluate signals in the PV-QC interface. I am happy to provide additional information on the successful collaboration with Paul and would recommend him without reservation for his outstanding professional and personal characteristics.

Peter