Experienced experts supporting strategic objectives while strengthening leadership, operations, cultures and reputations.
Addressing Needs and Challenges
Our trusted advisors are recognized authorities in their areas of expertise, many working inside enterprises similar to yours. They’ve sat in your
seat and have known what it’s like to address concerns from inside an organization. We use that experience to work hard to find great solutions that benefit you.
- We communicate frequently and transparently with you and your team about goals and progress.
- Our strategies help leadership and staff to succeed, and to hold themselves accountable for that success.
- We measure and monitor progress regularly and offer reports that let you change course and redirect resources when necessary to eliminate processes that aren’t working and amplify those that are.
- We help you to streamline operations for greater efficiencies that can improve the effectiveness, quality, speed and customer focus of your teams, and so much more. We have expertise in:
- Risk assessment, measurement, and mitigation
- Compliance controls and programs, assessments, and benchmarking
- Information privacy controls, and programs, assessments and benchmarking
- Product development and access, including clinical research, regulatory engagement, coverage, and coding and reimbursement strategy and execution
- Product marketing and promotion
- Professional compensation and relationships
- Customer contracts and relationships
- Interactions with government officials
- Education and educational support
- Charitable donations
- Third party contracted research, manufacturing and sales organizations
- Open payments and transparency
- Mergers and acquisitions
- FDA and notified body regulatory quality system compliance
- Government audits and inquiries
- Internal investigations and audits
- Litigation support
- International business compliance
- Remote, part time, and interim Compliance and Privacy Officer
“With over 100 years of combined leadership experience inside international medical device and biotech companies our team of skilled professionals understand the dynamics of your position, your goals and your challenges, and works closely with you to support your success.”
– from Jeffrey Miller, Director-in-Charge
“It takes years to build a good reputation and 5 minutes to destroy it”
– from Clivetty Martinez, Senior Consultant
“Whether it is watching Dr. Martinez conduct meetings, negotiate with possible speakers, or teach complex materials herself, one has to realize there is a master at work. She has an extremely polished manner at all times. My sense of her extraordinary strength and grace under pressure was only reinforced when I participated in an international Compliance Congress in Sao Paulo in August of 2012, where Dr. Martinez presented to an audience of 500 and also to small groups of 30-40 people. In both she was in command of the topic, used slides in an engaging way, entertained and addressed questions fluidly, and just generally presented herself as a most approachable expert.“
– from a retired professor and director of a major university’s Compliance and Business Ethics Program
Meet the Pharmaceutical Team Leads
Clivetty Martinez, Ph.D., CCEP, CHC, MOT
Clivetty Martinez, Ph.D., CCEP, CHC, MOT, is an internationally recognized, seasoned professional with global compliance and privacy experience in the healthcare, life sciences and consumer products industries. She has designed, built, developed, and led global compliance and privacy programs at several multinational companies across the pharmaceutical, consumer products, medical device, lab services and animal health industries. She has held several positions of increasing responsibilities up to and including Vice President and Chief Compliance Officer in national and global companies including Johnson & Johnson, Myriad Genetics, Akorn Pharmaceuticals, Perrigo, and Wyeth.
Director, Quality Systems and Compliance
Ken Geskes, Director, Quality Systems and Compliance, is an experienced life sciences executive and consultant, who brings more than 40 years of skills and insight to the Quality Systems and Compliance practice group. In addition to having expertise in quality system design, implementation, assessment, and remediation experience, Ken has managed operational activities associated with initial design concept through production, labeling, marketing, distribution, and post-distribution activities. This includes on site experience across the US, Canada, Europe, the Middle East, Latin America, and Asia and includes firsthand experience with both face-to-face and behind the scenes activities associated with regulatory and notified body audits.