Terms and Conditions

1. About Regulatory Passport

Regulatory Passport provides regulatory affairs, market-entry, compliance, advisory, research, documentation, project-management and related professional services to businesses operating in regulated industries.

Our services may include, among other things:

• regulatory strategy and market-entry assessments;
• product classification and pathway assessments;
• regulatory gap assessments;
• regulatory submissions and documentation support;
• technical documentation and dossier reviews;
• regulatory intelligence and research;
• post-approval and lifecycle support;
• labelling and product information reviews;
• manufacturer, supplier, CMO and CDMO sourcing or assessments;
• regulatory due diligence;
• coordination with regulatory specialists, consultants and local partners; and
• other regulatory, compliance or market-access services agreed with a client.

The precise scope, deliverables, fees and timelines for a particular engagement may be set out in an order, proposal, statement of work, engagement letter or other written agreement.

2. Professional Services

Regulatory requirements differ between products, jurisdictions and circumstances and may change over time.

Our services are provided based on the information available to us, applicable regulatory requirements, professional judgement and the agreed scope of work at the relevant time.

Unless expressly agreed otherwise in writing, our services do not constitute legal, tax, accounting, medical, investment or other regulated professional advice.

Where legal interpretation or formal legal advice is required, you should obtain advice from appropriately qualified legal counsel.

3. No Guarantee of Regulatory Approval

Regulatory Passport does not guarantee:

• regulatory approval, clearance, certification or registration;
• acceptance of any application or submission;
• any particular classification or regulatory determination;
• approval within a particular timeframe;
• acceptance by a notified body, competent authority or other third party;
• successful market entry; or
• any particular commercial outcome.

Regulatory decisions remain at the discretion of the relevant regulatory authority, notified body, certification body or other competent organisation.

Timelines provided by Regulatory Passport are estimates unless expressly stated otherwise.

4. Independent Regulatory Service Provider

Unless expressly stated otherwise in writing for a particular engagement, Regulatory Passport is an independent professional-services provider.

Regulatory Passport is not itself a governmental regulatory authority.

Unless specifically appointed and agreed in writing, Regulatory Passport does not act as your legal representative, authorised representative, responsible person, marketing authorisation holder, importer, sponsor, notified body, conformity assessment body or other legally designated regulatory role.

Any such role requires a separate written agreement and may be provided by an appropriately qualified third-party organisation.

5. Experts, Consultants and Partners

Regulatory Passport may use employees, independent experts, consultants, specialist contractors, laboratories, local regulatory professionals, partner organisations or other third-party service providers in delivering services.

Regulatory Passport may select and coordinate appropriate specialists based on the requirements of an engagement.

Where Regulatory Passport contracts directly with you for a managed service, our use of specialists or subcontractors does not by itself change your contractual relationship with Regulatory Passport.

Certain services may, however, require you to enter into a separate agreement directly with a third-party provider. Where this applies, we will make this clear.

6. Client Responsibilities

You are responsible for providing information and documentation that is accurate, complete, current and not misleading.

You must promptly notify us if relevant information changes.

You remain responsible for:

• your products and business activities;
• the accuracy and completeness of information supplied to us;
• final business and regulatory decisions;
• compliance with applicable laws and regulatory requirements;
• implementation of recommendations;
• maintaining required licences, registrations and approvals; and
• reviewing and approving submissions or documents where client approval is required.

Regulatory Passport is not responsible for errors, delays or unsuccessful outcomes resulting from inaccurate, incomplete, outdated or withheld information supplied by you or third parties acting on your behalf.

7. Regulatory Information

Regulatory information may change due to new legislation, guidance, regulator interpretations, court decisions or administrative practices.

Unless an engagement specifically includes ongoing monitoring, our advice and deliverables speak as of the date on which they are provided.

We are not obligated to update previously delivered work because of subsequent regulatory changes unless separately agreed.

8. Proposals and Statements of Work

A specific engagement may be governed by a proposal, quotation, order form, statement of work, engagement letter or other written agreement ("SOW").

An SOW may specify:

• scope;
• deliverables;
• assumptions;
• exclusions;
• fees;
• payment schedule;
• estimated timeline;
• client dependencies; and
• project-specific terms.

If there is a conflict between these Terms and an expressly agreed SOW, the SOW will prevail in relation to that engagement to the extent of the conflict.

9. Fees and Payment

Fees will be displayed on the website, communicated before purchase or specified in the applicable proposal or SOW.

Unless stated otherwise:

• fees are exclusive of applicable taxes;
• payment must be made according to the agreed payment schedule;
• work may begin only after any required upfront payment has been received; and
• we may suspend work where an invoice remains overdue.

Third-party charges, including regulator fees, government fees, laboratory costs, translation charges, notified-body fees, certification fees, legal fees and local representative fees, are not included unless expressly stated.

10. Cancellations and Refunds

Because many Regulatory Passport services involve professional time, research, expert allocation and customised work, payments may become non-refundable once work has commenced.

Where a client cancels an engagement after work has begun, Regulatory Passport may charge for:

• work already completed;
• professional time already committed;
• non-cancellable third-party costs; and
• other amounts specified in the relevant SOW.

Any service-specific cancellation or refund terms displayed at purchase or contained in an SOW will apply to that engagement.

Nothing in this section limits any mandatory rights that cannot lawfully be excluded.

11. Intellectual Property

Regulatory Passport and its licensors retain ownership of their pre-existing intellectual property, including methodologies, frameworks, templates, processes, software, databases, know-how and proprietary materials.

Subject to full payment of applicable fees, you may use final client-specific deliverables for your internal business and regulatory purposes.

Unless expressly agreed otherwise, you may not:

• commercially resell our deliverables;
• reproduce our proprietary templates as your own;
• distribute proprietary methodologies to third parties;
• reverse engineer our systems or platform; or
• remove proprietary notices.

You retain ownership of materials and intellectual property supplied by you to us.

You grant us the rights reasonably necessary to use those materials for providing the agreed services.

12. Confidentiality

Each party may receive confidential or commercially sensitive information from the other.

Each party agrees to use reasonable measures to protect confidential information and to use it only for purposes connected with the relevant engagement.

Confidential information may be disclosed where:

• required by law or a competent authority;
• required to professional advisers subject to confidentiality obligations;
• necessary for approved service providers or specialists involved in delivering the engagement; or
• authorised by the party that owns the information.

More detailed confidentiality obligations may be contained in a separate NDA or SOW.

13. Data Protection

Personal data is handled in accordance with our Privacy Policy and applicable data-protection laws.

Where an engagement involves processing personal data on behalf of a client, additional data-processing terms may apply.

14. Third-Party Services

Our services may involve or refer to third-party organisations, including regulatory authorities, laboratories, notified bodies, consultants, manufacturers, suppliers, CMOs, CDMOs, authorised representatives and technology providers.

Unless expressly agreed otherwise, Regulatory Passport does not control these organisations and does not guarantee their performance, availability, pricing, decisions or regulatory acceptance.

A recommendation, introduction or assessment of a third party does not constitute a guarantee of that party's future performance.

Clients should undertake appropriate commercial and legal due diligence before entering into material third-party relationships.

15. Website Information

Information available on the Regulatory Passport website, including articles, guides, calculators, country information, regulatory summaries and other general content, is provided for general informational purposes.

It should not be treated as advice specifically tailored to your product or circumstances.

You should not make significant regulatory, legal, financial or commercial decisions solely on the basis of general website content.

16. Limitation of Liability

To the maximum extent permitted by applicable law, Regulatory Passport will not be liable for indirect, incidental, special or consequential losses, or for loss of profits, revenue, business opportunity, anticipated savings, goodwill or data arising from or connected with the use of our services.

To the maximum extent permitted by law, Regulatory Passport's aggregate liability arising from a particular paid engagement will not exceed the fees actually paid to Regulatory Passport for the specific engagement giving rise to the claim.

Nothing in these Terms excludes or limits liability where such liability cannot lawfully be excluded or limited.

17. Indemnity

To the extent permitted by applicable law, you agree to indemnify Regulatory Passport against third-party claims, losses or costs arising directly from:

• materially false or misleading information supplied by you;
• your unlawful use of our services or deliverables;
• infringement caused by materials supplied by you; or
• your violation of applicable law,

except to the extent that the relevant claim results from Regulatory Passport's own breach, negligence or misconduct.

18. Conflicts of Interest

Regulatory Passport may provide services to multiple organisations operating within the same industries.

We may conduct conflict checks where appropriate and may decline, suspend or reassign an engagement where an actual or potential conflict of interest arises.

Our experts and consultants may also be subject to professional, contractual or employment-related conflict requirements.

19. Suspension or Termination

We may suspend or terminate services where reasonably necessary, including where:

• fees remain unpaid;
• required information is repeatedly not provided;
• continuing the engagement may breach applicable law or professional obligations;
• a material conflict of interest arises;
• abusive or unlawful conduct occurs; or
• these Terms or an applicable SOW are materially breached.

Termination does not affect rights or payment obligations accrued before termination.

20. Force Majeure

Neither party will be liable for delays or failure to perform caused by events beyond its reasonable control, including governmental actions, regulatory delays, natural disasters, war, civil disturbances, widespread technology failures or other comparable events.

21. Electronic Communications

You agree that communications, agreements, notices, invoices and other documents may be provided electronically.

Electronic acceptance of a proposal, order or agreement may constitute acceptance of the applicable contractual terms.

22. Changes to These Terms

We may update these Terms from time to time.

The current version will be published on our website together with the date of the latest update.

Material changes will apply prospectively unless applicable law permits otherwise.

23. Governing Law and Jurisdiction

These Terms and any dispute arising from them are governed by the laws of Singapore.

Subject to any dispute-resolution mechanism expressly agreed in an applicable SOW, the courts of Singapore will have jurisdiction over disputes arising from or relating to these Terms.

24. General

If any provision of these Terms is found to be invalid or unenforceable, the remaining provisions will continue in effect.

A failure to enforce a provision does not constitute a waiver of that provision.

You may not assign your rights under an engagement without our prior written consent, except as permitted in the relevant SOW.

25. Contact

Regulatory Passport is operated by:

Email: hello@regulatorypassport.com

For contractual, legal or service-related enquiries, please contact us using the details above.