Terms and Conditions

These Terms and Conditions ("Terms") govern your use of this website and any consulting services provided by Tailwind Pharma, LLC ("Tailwind Pharma", "we", "us"). By booking a call, purchasing services, or otherwise engaging us, you agree to these Terms. Where a signed engagement letter, statement of work, or master services agreement exists, that document controls to the extent it conflicts with these Terms.

Tailwind Pharma provides regulatory and quality consulting services, which may include inspection readiness and mock inspections, Form FDA 483 and Warning Letter response strategy, remediation planning, investigation, CAPA and OOS support, data integrity assessment, contract manufacturing oversight, due diligence, expert witness support, and fractional executive quality leadership.

Services are limited to the deliverables described in the applicable scope of work. We do not act as your quality unit, regulatory agent, or decision-maker of record. Regulatory submissions, disposition decisions, and communications with health authorities remain your responsibility.

Engagements are scoped based on urgency, duration, travel, consultant count, document volume, specialized expertise, and remediation needs. The standard on-site rate is $5,000 per day per consultant with a two-day minimum, as stated on our pricing page.

Unless the engagement letter states otherwise, fixed fees and day rates are payable in advance and hourly or retainer work is invoiced monthly with payment due within thirty (30) days. Travel, lodging, and other out-of-pocket expenses are billed at cost. Card If card payments are offered, they are processed by Stripe; we do not store payment card details. Fees are exclusive of any applicable sales, use, VAT, GST, or withholding taxes, which are your responsibility.

The introductory triage call may be rescheduled or cancelled at any time at no cost. For scheduled on-site or fixed-date engagements, cancellation or rescheduling requested fourteen (14) or more calendar days before the first scheduled day is credited in full toward a future engagement. Requests inside fourteen (14) days may be subject to a charge of up to fifty percent (50%) of the scheduled fee, plus non-refundable travel costs already incurred. Requests inside forty-eight (48) hours may be charged in full.

You agree to provide timely, accurate, and complete information, documents, site access, and personnel availability reasonably necessary for us to perform the services. Our findings and recommendations are based on the information made available to us at the time of the engagement. Delays or incomplete information may affect timelines, deliverables, and fees.

We treat non-public client information as confidential and use it only to perform the services. A mutual confidentiality agreement can be executed before substantive confidential information is exchanged. Confidentiality obligations do not apply to information that is public, independently known, or required to be disclosed by law or valid legal process.

Deliverables prepared specifically for you become yours upon full payment. Tailwind Pharma retains ownership of its pre-existing and general methodologies, templates, checklists, frameworks, tools, and know-how, including anything of general application developed during an engagement, and may reuse them for other clients. Website content, branding, and marks remain the property of Tailwind Pharma.

Tailwind Pharma provides regulatory, quality, and compliance consulting. Nothing provided by us constitutes legal advice, and engaging us does not create an attorney-client relationship or attorney-client privilege. Where legal risk is present, you should engage qualified counsel; we routinely work at the direction of counsel.

Regulatory outcomes are determined solely by the FDA and other competent authorities. We do not represent, warrant, or guarantee any specific inspection classification, enforcement decision, approval, closeout, timeline, or other regulatory result. We claim no special influence over, or privileged access to, any government agency or decision-maker. Services are provided on a professional best-efforts basis.

To the maximum extent permitted by law, Tailwind Pharma's total aggregate liability arising out of or relating to an engagement is limited to the fees actually paid by you for that engagement. Neither party is liable for indirect, incidental, special, consequential, exemplary, or punitive damages, or for lost profits, lost revenue, lost production, product recalls, or business interruption, even if advised of the possibility. Nothing in these Terms limits liability that cannot be limited by law.

This website relies on third-party services for scheduling (TidyCal), communications, and consent-based analytics. Their terms and privacy practices apply to their portions of the experience. Website content is provided for general information only and does not create a consulting relationship. Do not rely on it as a substitute for an engagement.

During an engagement and for twelve (12) months afterward, neither party will directly solicit for employment the other party's personnel who were substantially involved in the engagement, without prior written consent. General public job postings are not a breach of this section.

Either party may terminate an engagement on fourteen (14) days' written notice, or immediately for material breach that remains uncured for ten (10) days after notice. On termination you remain responsible for fees for services performed and non-cancellable costs incurred through the effective date.

These Terms are governed by the laws of the State of Kansas, United States, without regard to its conflict-of-laws rules. The parties will first attempt to resolve any dispute in good faith between senior representatives. Any unresolved dispute will be submitted to the exclusive jurisdiction of the state and federal courts located in Johnson County, Kansas, and each party waives any objection to venue there.

We work with clients outside the United States. Services delivered outside the United States, including non-CONUS on-site work, are quoted on separate terms. You are responsible for compliance with your local laws, import and export requirements, and any applicable data-transfer obligations relating to information you share with us.

We may update these Terms from time to time. The version in effect when your engagement is signed applies to that engagement. Continued use of this website after an update constitutes acceptance of the revised Terms.

Questions about these Terms: jlambert@tailwindconsult.com.