Terms of Service

By accessing or using the website biostate.in or any services provided by Bio-State Consulting Pvt. Ltd. ("Bio-State", "we", "us", "our"), you agree to be bound by these Terms of Service ("Terms").

If you do not agree to these Terms, please do not use our website or services. We may update these Terms from time to time, and continued use of the website constitutes acceptance of the updated Terms.

Bio-State provides regulatory consulting services for medical device and IVD manufacturers, including but not limited to:

• CDSCO licensing and documentation support (manufacturing, import, sale)
• ISO 13485 quality management system implementation and audit support
• Clinical investigation and Performance Evaluation Report (PER) services
• CE Mark and EU MDR regulatory pathway support
• GMP manufacturing facility design and validation
• Market access, distribution, and GeM portal services
• Authorised Indian Agent representation for foreign manufacturers

All paid engagements are governed by a separately executed Master Services Agreement (MSA) and Statement of Work (SOW). The MSA and SOW prevail over any conflict with these Terms.

Scoping calls and preliminary discussions before MSA execution are provided without charge and do not constitute a binding engagement. Either party may decline to proceed.

Fees, milestones, and payment terms for each engagement are specified in the applicable SOW. Standard payment terms are 30 days from invoice date unless otherwise agreed.

Late payments may incur interest at 1.5% per month (or the maximum permitted by law) from the due date until paid in full.

Out-of-pocket expenses (regulatory body fees, third-party lab charges, travel where applicable) are billed at cost with prior written approval.

Successful delivery of our services depends on timely cooperation. By engaging us, you agree to:

• Provide accurate and complete information about your devices, processes, and existing documentation
• Make personnel available for interviews, reviews, and audits within agreed timeframes
• Pay regulatory body fees, lab charges, and notified-body fees directly when invoiced by those entities
• Notify us promptly of any material changes to device design, intended use, or target markets
• Maintain the confidentiality of our work product and methodologies

You retain full ownership of your device designs, technical files, clinical data, and any pre-existing intellectual property you share with us.

Bio-State retains ownership of its proprietary methodologies, templates, internal tools, and accumulated regulatory knowledge. Deliverables we produce specifically for you (e.g., dossiers, SOPs, PERs) become your property upon full payment.

Neither party may use the other's name, logo, or marks publicly without written consent, except as required for regulatory filings.

Each party agrees to protect the other party's confidential information with the same degree of care it uses to protect its own confidential information (and never less than reasonable care).

Confidential information does not include information that is publicly known, independently developed without reference to the disclosing party's information, or required to be disclosed by law.

Confidentiality obligations survive termination of any engagement for a period of 5 years.

We bring significant experience and a strong track record (95%+ first-pass approval rate) to every engagement. However, we cannot guarantee that any specific regulatory body will approve any specific submission.

Approval decisions rest exclusively with the relevant regulatory authority. Our fees are for the work performed, not contingent on approval outcomes.

To the maximum extent permitted by law, Bio-State's aggregate liability under any engagement is limited to the fees paid by you for the specific deliverable that gave rise to the claim.

Bio-State is not liable for indirect, incidental, consequential, or punitive damages, including but not limited to lost profits, lost business opportunities, or business interruption.

Nothing in these Terms limits liability for fraud, gross negligence, or any liability that cannot be excluded by law.

Either party may terminate an engagement for material breach by the other party that remains uncured 30 days after written notice.

You may terminate any engagement at any time for convenience, subject to payment for work completed up to the termination date and any committed third-party expenses.

Sections relating to payment for completed work, intellectual property, confidentiality, and limitation of liability survive termination.

These Terms and any disputes arising from them are governed by the laws of India.

Any dispute that cannot be resolved through good-faith discussions will be subject to the exclusive jurisdiction of the courts in Noida, Uttar Pradesh, India.

Before initiating any formal proceedings, both parties agree to attempt resolution through mediation conducted by a mutually-agreed mediator.

For questions about these Terms of Service, contact us:

Email: regulatory@biostate.in

Phone: +91 78005 66807

Address: Bio-State Consulting Pvt. Ltd., No. 12, 10th Floor, Gulshan One29, Sector-129, Noida, Uttar Pradesh 201301, India.