Regulatory Strategy · Clinical Development · Medical Affairs
Across the Product Lifecycle One Accountable Expert
Twenty-plus years of in-house pharmaceutical leadership applied to regulatory strategy,
clinical development, and medical affairs, with compliance, commercial
analytics, and market research support when your program calls for it.
EKEric R. Kinzler, PhDFounder & Principal Consultant
Pellucid Advantage was founded more than a decade ago by Eric R. Kinzler, PhD,
who leads the firm today as its principal consultant. Eric holds a doctorate in Cellular and
Molecular Biology from UW–Madison and brings more than two decades of in-house leadership and
consulting across branded, generic, and investigational products.
Eric has served as Vice President of Medical & Regulatory Affairs, Head of Quality, Study Director at
GLP/CLIA/CAP-accredited laboratories, and scientific lead at FDA Advisory Committee meetings —
including providing expert testimony. He has helped drive numerous drug approvals and
end-to-end product launches, contributing to several approved applications, class-wide REMS
programs, and quality management systems built from the ground up.
Healthcare compliance is a discipline of its own, and one Eric has worked in for many years.
He served as an Independent Board Member overseeing a company's obligations under an OIG Corporate
Integrity Agreement, and today is a key member of the compliance committee for a commercial-stage
specialty pharmaceutical company, contributing across its compliance program: policies and SOPs,
training, promotional and field-force oversight, HCP interactions and transparency reporting,
monitoring and auditing, and the review of concerns as they arise.
Today that experience extends into the commercial organization. Eric built and runs a
sales analytics and reporting platform and a prescriber market research program for specialty
pharmaceutical clients, giving field teams and executives timely, decision-ready insight,
built by someone who knows exactly what the data can and cannot be used for.
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Years of pharma leadership & consulting
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Principal on every engagement, start to finish
PhD
Cellular & Molecular Biology, UW–Madison
VP+
Executive roles across medical, regulatory, quality & compliance
Services
What we do
Three practices, one point of accountability. Most clients start with one and find the others close at hand.
Executive-level expertise on demand for branded and generic manufacturers, from your first Agency meeting through launch, post-marketing commitments, and the day-to-day compliance of a commercial organization.
Clinical & Regulatory Strategy
Pre-IND through NDA/ANDA strategy, FDA meeting preparation and facilitation, Advisory Committee support including expert testimony, clinical data analysis and interpretation, and regulatory document development.
Generic Drug (ANDA) Support
Regulatory strategy and FDA communications for generic manufacturers: controlled correspondence, responses to deficiency letters and information requests, labeling and shared-system REMS questions, and post-approval changes.
Precommercial Planning & Launch
End-to-end launch readiness: go-to-market strategy, medical affairs build-out, payer value proposition development, access and reimbursement planning, Scientific Advisory Boards, publication strategy, and promotional material review.
Regulatory & Promotional Compliance
Advertising and promotion strategy, medical-legal-regulatory (MLR) review committee design and facilitation, REMS program management, FDA 483 response, CAPA implementation, and post-marketing commitment oversight.
Healthcare Compliance
Building and supporting compliance programs aligned with OIG guidance: compliance officer and committee structure, policies and SOPs, training, field-force and promotional oversight, Anti-Kickback and fair-market-value review, Open Payments and state transparency reporting, PhRMA Code alignment, auditing and monitoring, and investigations — including ongoing compliance committee support.
Quality Management Systems & SOPs
Design, implementation, and management of QMS aligned with cGMP requirements. Policy and SOP development, compliance training programs, and audit readiness — including FDA and pharmacovigilance inspection support.
Medical Affairs Strategy
Medical information and pharmacovigilance operations, MSL program design, Advisory Board execution, KOL development, scientific communications, and cross-functional support for field teams and strategic partners.
Transactions & Transitions
Due diligence support, co-promote structuring, product divestitures, and transfers to new ownership — including supply chain transition, REMS transfers, and regulatory notifications required at change of ownership.
Abuse-Deterrent Product Testing
Study protocol design, laboratory oversight, data analysis and interpretation, and regulatory submissions for abuse-deterrent formulations — including Category 1–4 testing reports aligned with FDA guidance.
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Commercial Analytics
Sales and prescribing analytics for your field team and leadership, delivered as a managed service. We take in your prescription, call-activity, payer, and territory data and deliver finished, decision-ready reports every week, with compliance rules built in.
Field & Territory Reporting
Weekly territory and representative reports delivered through secure links built for phones and tablets: trends, top prescribers, call coverage, and opportunity, refreshed automatically when new data lands.
Executive Reporting
Weekly executive summaries and slide-ready decks with written commentary, quarter-to-date pacing against goals, payer and pharmacy dynamics, and the exceptions that need attention.
Incentive Compensation
Plan design support and back-testing, then period-by-period calculation and publishing of results, reconciled to the same data the field sees every week.
Targeting & Segmentation
Prescriber segmentation, target and call-plan lists, growth and decline monitoring, and payer-mix grading, with PDRP opt-outs and other restrictions applied automatically.
AI & Automation
A secure, client-specific AI assistant that answers plain-English questions about your own data, plus practical AI consulting for regulated organizations: workflow automation, document review, and responsible deployment.
Data Operations
Intake and validation of syndicated prescription, specialty pharmacy, co-pay, and CRM feeds; vendor restatement handling; territory alignment; and quality checks, so the numbers hold up.
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Market Research
Prescriber and stakeholder research designed to stand up to compliance review, from the first contact to the final payment.
Study Design & Interviews
Research objectives, discussion guides, and one-on-one interviews conducted by a senior pharmaceutical professional, with findings reported in aggregate.
Compliant Recruitment & Scheduling
Selection criteria documented before any contact, invitations respondents choose to answer themselves, secure self-scheduling, and a complete audit trail. Field teams never learn who took part.
Honoraria & Transparency
Fair-market-value honoraria by credential, written consulting agreements, and support for Open Payments (Sunshine Act) reporting.
Research firewall. Information shared by research participants is used only for the research.
It is never joined to individual prescribing data and never used for sales targeting, field reporting, or incentive compensation.
How We Work
One accountable expert. The right bench behind it.
Every engagement is led personally by Eric, from scoping and strategy through the final work product.
Clients get senior judgment from the first call, not a hand-off to junior staff.
When a program needs more hands or specialized depth, Eric brings in trusted colleagues he has worked
with for years — regulatory writers and counsel, biostatisticians, pharmacovigilance and medical
information professionals, quality and compliance specialists, and data engineers — and manages them
as one team under a single engagement.
Principal-led
Eric owns the strategy and signs off on every deliverable.
Scaled to the work
Specialists join when the program calls for them, and only then.
One point of accountability
One contract, one contact, one standard of quality.
Track Record
Selected accomplishments
Category 1 abuse-deterrent testing for nearly every FDA-approved abuse-deterrent product on the market.
Expert testimony and full sponsor presentations at FDA Advisory Committee meetings.
Authored key sections of multiple approved NDAs.
Hosted FDA and pharmacovigilance inspections; led Form 483 responses and CAPAs.
Built medical information, pharmacovigilance, and quality systems for multiple branded launches.
Independent Board Member under an OIG Corporate Integrity Agreement, and compliance committee member overseeing regulatory and healthcare compliance for multiple specialty pharmaceutical companies.
Get in Touch
Let's talk about your program
Whether you're preparing for a regulatory milestone, building out medical affairs, strengthening your compliance program, standing up
commercial reporting for a launch, or planning prescriber research — we'd welcome an
introductory conversation.
Engagements are structured to fit your needs: project-based, retainer, managed service, or
fractional executive support. Confidential. No long-term commitments required to get started.
And if we aren't the right fit for your challenge, we'll tell you so and point you toward someone who is.
Pellucid Advantage LLC (“Pellucid,” “we,” “us”) is a pharmaceutical consulting firm. This policy explains what personal information we collect, how we use it, who we share it with, and the choices you have.
The short version
Our public website sets no cookies. We use privacy-friendly, cookieless analytics on our website and portals that do not identify you.
We do not sell personal information or share it for advertising.
Information from market research participants is used only for the research. It is never used for sales or promotion.
You can ask us what we hold about you, or ask us to correct or delete it, by emailing info@pellucidadvantage.com.
What This Policy Covers
This policy applies to:
our website, www.pellucidadvantage.com;
client portals and tools we operate on pellucidadvantage.com addresses, such as reporting and analytics portals and AI-assisted tools;
market research studies we conduct, including invitation and scheduling pages at research.pellucidadvantage.com;
electronic signature at sign.pellucidadvantage.com; and
email and other communications with us.
When we process information on behalf of a client under an engagement agreement, for example a client’s sales or prescription data in a reporting portal, we act as that client’s service provider. That information is handled under our agreement with the client and the client’s own privacy policy, and requests about it are best directed to the client.
Information We Collect
Information you give us
When you email us or contact us, we receive your name, email address, and whatever you choose to include. Please do not send confidential or proprietary information until a confidentiality agreement or engagement is in place.
Website and portal visits
We measure traffic on our website, portals, and research pages with analytics software that we host ourselves and that uses no cookies and no cross-site tracking. It records the pages viewed, the referring site, browser, operating system, device type, and an approximate country or region. Your IP address is used to estimate location and, combined with your browser details, to create an anonymous identifier that resets every day. Your IP address is not stored in our analytics. Personal link codes and identifiers, such as the code in an invitation or report link or a National Provider Identifier, are removed from page addresses before anything is recorded, and page titles are not recorded for those pages. If your browser sends a Do Not Track signal, no analytics data is collected. Like any website, our web servers also keep standard technical logs (such as IP address, time, and page requested), which we use only for security and troubleshooting and keep for a limited period.
Client portals and tools
If you are given access to a client portal, we collect your name and email address, sign-in records (such as time, IP address, and browser), and your activity in the portal, including questions you submit to AI-assisted tools. Portal access is provided at the direction of our client, your employer or organization.
Market research participants
See Market Research below.
Electronic signatures
When you sign a document through our signing service, it records your name, email address, signature, the date and time of signing, your IP address, and an audit trail of the signing steps, so the signed document can be verified later.
Market Research
We conduct market research studies, including interviews with healthcare professionals, on behalf of pharmaceutical companies. The study sponsor is named in the invitation.
What we collect. To invite you, we use your name, professional credential, specialty, city and state, and National Provider Identifier (NPI), all of which are professional details listed in public directories. If you agree to be contacted, we also keep the email address you give us, a record of your consent (the date and the wording you agreed to), your interview booking, and what you tell us during the interview. Visits to invitation pages are counted only in the anonymous analytics described above, with the personal link code removed.
Research use only. Information you provide as a research participant is used only for the research. It is not shared with sales representatives, and it is not used for sales targeting, sales reporting, sales compensation, or promotion.
How results are reported. We report findings to the sponsor in aggregate, without your name. We do not attribute comments to you by name without your permission.
Honoraria. Where an honorarium is offered, it is paid by the sponsor under an agreement you sign with the sponsor. The sponsor collects any tax form (such as an IRS Form W-9) directly through its own system; Pellucid does not collect your taxpayer identification number. Under the federal Open Payments program, the sponsor may be required to report the payment to the Centers for Medicare & Medicaid Services (CMS), which publishes those reports.
Your choice. Taking part is voluntary. You can decline or withdraw at any time using the link in our emails or by emailing us.
How We Use Information
To provide our website, portals, and services, and to keep them secure.
To respond to you and communicate with you about our services or an engagement.
To conduct the market research studies described above.
To understand, in aggregate, how our website is used and improve it.
To meet legal obligations, enforce our agreements, and protect our rights.
Cookies
Our public website sets no cookies. Our client portals and signing service use only cookies that are strictly necessary to sign you in, keep your session secure, and remember settings you choose. We do not use advertising cookies, social media pixels, or cross-site tracking.
How We Share Information
We do not sell personal information, and we do not share it for targeted advertising. We share it only as follows:
Service providers that help us operate, under obligations to protect it: Microsoft (email, calendar, Microsoft Teams, and cloud backup), Anthropic (an AI model provider that processes questions submitted to our AI-assisted tools, under commercial terms that do not permit using that data to train its models), and Brevo (delivery of signing-service email).
Our clients, for information we process on their behalf, and research sponsors as described under Market Research.
Legal and safety: when required by law or valid legal process, or to protect the rights, property, or safety of Pellucid or others.
Business transfers: in connection with a merger, acquisition, or sale of assets, subject to this policy.
Where Information Is Stored
Our services run on servers we operate in the United States, and information is processed in the United States. If you contact us from outside the United States, your information will be transferred to and processed in the United States.
How Long We Keep Information
Website analytics are anonymous and kept in aggregate.
Server and sign-in logs are kept for a limited period for security and troubleshooting.
Portal accounts are kept while access is active and for a reasonable period afterward, or as our client agreement requires.
Market research records are kept for the duration of the study and as long as needed to document consent and support the sponsor’s legal reporting obligations, and are then deleted.
Signed documents and their audit trails are kept as long as the agreement and applicable law require.
Security
We protect personal information with access controls, protected sign-in for portals and administrative tools, and encrypted connections (HTTPS). No method of transmission or storage is completely secure, so we cannot guarantee absolute security.
Your Choices and Rights
You may ask us to tell you what personal information we hold about you, to correct it, or to delete it, and you may opt out of research contact at any time. Email info@pellucidadvantage.com. We may need to verify your identity, and we will respond within 45 days. Residents of some states have additional rights under state privacy laws, and we will honor them where they apply. If your request concerns information we process for a client, we will refer it to that client.
Children
Our services are intended for business and professional users and are not directed to children. We do not knowingly collect personal information from anyone under 18.
Links to Other Websites
Our website may link to sites we do not operate. Their privacy practices are their own, and we encourage you to review their policies.
Changes to This Policy
We may update this policy from time to time. We will post the updated policy on this page and change the “Last updated” date above.
These Terms and Conditions (“Terms”) govern your use of www.pellucidadvantage.com and the portals, tools, and pages that Pellucid Advantage LLC (“Pellucid,” “we,” “us”) operates on pellucidadvantage.com addresses (together, the “Services”). By using the Services, you agree to these Terms. If you use the Services on behalf of a company or other organization, you agree to them on its behalf.
Client Agreements Come First
If you access a client portal or receive our services under a written engagement agreement, master services agreement, statement of work, or similar contract, that agreement governs our services and your use of the portal. If it conflicts with these Terms, the agreement controls.
No Professional Advice; No Consulting Relationship
Content on our website is general information about Pellucid and our areas of practice. It is not regulatory, legal, medical, compliance, or other professional advice for your situation, and it is not medical advice for patients. Using the website, or emailing or calling us, does not create a consulting or other professional relationship. A relationship exists only under a written agreement signed by Pellucid.
Information You Send Us
Please do not send us confidential or proprietary information until a confidentiality agreement or engagement is in place. Information sent before then is not treated as confidential and does not create any obligation for Pellucid, including any restriction on the work we do for others.
Portals, Accounts, and Personal Links
Portal access is by invitation only. Keep your sign-in credentials secure, do not share them, and tell us promptly if you believe your account has been used without your permission.
Portal content belongs to, or is confidential to, our client. Use it only as your organization authorizes, and do not download, copy, or share it beyond that authorization.
Some pages, such as research invitations and report links, are reached through a personal link. These links are for the named recipient only. Do not forward or publish them.
We may suspend or end access at our client’s direction, when an engagement ends, or to protect the security of the Services.
AI-Assisted Tools
Some of our tools use artificial intelligence to answer questions or draft content. AI output can be incomplete or wrong. Check it against the underlying data or source before relying on it, and do not treat it as professional advice. Enter only information you are authorized to share.
Acceptable Use
You agree not to: access or attempt to access any part of the Services without authorization; probe, scan, or test their security; interfere with their operation; scrape or harvest content by automated means; introduce malware; or use the Services for any unlawful purpose.
Intellectual Property
The website and its content, design, and logos belong to Pellucid or its licensors. You may view and print pages for your own informational or internal business use. Any other use requires our written permission. Other names and marks belong to their owners.
Links to Other Websites
The Services may link to websites we do not own or control. We are not responsible for their content, policies, or practices, and a link is not an endorsement.
Disclaimer
The Services are provided “as is” and “as available.” To the fullest extent permitted by law, Pellucid disclaims all warranties, express or implied, including warranties of merchantability, fitness for a particular purpose, title, and non-infringement. We do not warrant that the Services will be uninterrupted, error-free, or free of harmful components, or that their content is complete, accurate, or current. This section does not change any warranty in a signed client agreement.
Limitation of Liability
To the fullest extent permitted by law, Pellucid will not be liable for any indirect, incidental, special, consequential, or punitive damages, or for lost profits, revenue, or data, arising from your use of, or inability to use, the website. Our total liability for any claim relating to the website will not exceed 100 U.S. dollars. Liability relating to our services under a client agreement is governed by that agreement. Some jurisdictions do not allow these limitations, so they may not apply to you.
Governing Law
These Terms are governed by the laws of the State of Ohio, without regard to its conflict-of-laws rules. Any dispute relating to these Terms or the website will be brought in the state or federal courts located in Ohio, and you consent to their jurisdiction. Before filing a claim, please contact us so we can try to resolve the issue informally.
Export and Sanctions
You represent that you are not located in a country subject to a U.S. government embargo and are not on any U.S. government list of prohibited or restricted parties.
General
If any part of these Terms is found unenforceable, the rest remains in effect. Our failure to enforce a provision is not a waiver. These Terms, together with our Privacy Policy, are the entire agreement between you and Pellucid about use of the website, except where a signed client agreement applies.
Changes to These Terms
We may update these Terms from time to time. We will post the updated Terms on this page and change the “Last updated” date. Continuing to use the Services after an update means you accept the updated Terms.
