Acceptance of Terms and Professional Conduct
Welcome to the Biosin Pharma website. By accessing our site and utilizing our services, you agree to comply with and be bound by the following terms and conditions.
1. Standard Operating Terms for B2B Engagements
Review the Terms of Service for Biosin Pharma regarding our CDMO, CRAMS, analytical services, and website usage.
2. Service Agreements
All engagements for Custom Synthesis (CDMO,CMD), Process Development, and Analytical Services are governed by specific Master Service Agreements (MSAs) and Quality Agreements executed prior to project commencement.
3. Website Content
The information provided on this website, including but not limited to the product catalog and service descriptions, is for general informational purposes. While we strive for accuracy, Biosin Pharma does not warrant that product descriptions or other content is entirely error-free.
4. Regulatory Compliance
Clients engaging our Pharmaceutical CDMO and SCM Services must ensure that their requests comply with the laws and regulations of their respective jurisdictions, including FDA, EMA, or local equivalent standards.
5. Limitation of Liability
Biosin Pharma shall not be liable for any indirect, incidental, or consequential damages arising from the use of our website or reliance on its content prior to the signing of a formal commercial contract.
Navigating Our B2B Operational Terms:
How do Master Service Agreements (MSAs) govern our partnership?
The information presented on this website outlines our broad capabilities in CRAMS (Contract Research and Manufacturing Services). However, the actual execution of any project is strictly governed by a negotiated Master Service Agreement (MSA) and a specific Statement of Work (SOW). The MSA legally defines the overarching terms of our relationship, including confidentiality obligations, intellectual property rights, payment terms, and dispute resolution mechanisms. The SOW details the specific technical deliverables, timelines, and milestones for a given project. These formal documents supersede any general information provided on the website, ensuring that both Biosin Pharma and the client have a clear, legally binding framework for success.
What is the role of a Quality Agreement in our CDMO services?
In the highly regulated pharmaceutical industry, defining quality responsibilities is as important as defining commercial terms. Before commencing any GMP manufacturing or advanced Technology Transfer & Scale-Up project, Biosin Pharma and the client execute a formal Quality Agreement. This document delineates the specific responsibilities of each party regarding regulatory compliance, analytical testing standards, release criteria, change control protocols, and the handling of Out of Specification (OOS) results or deviations. It ensures that Biosin Pharma’s quality operations align perfectly with the client’s regulatory strategy and the mandates of the targeted health authorities.
How is liability managed regarding the supply of API Impurities and Intermediates?
Biosin Pharma warrants that the API Impurities and Intermediates supplied will meet the specifications explicitly agreed upon in the Certificate of Analysis (COA) provided at the time of shipment. However, it is the sole responsibility of the client to determine the suitability of these materials for their specific end-use application, whether it be further chemical synthesis, analytical testing, or inclusion in a commercial pharmaceutical product. Biosin Pharma’s liability is strictly limited to the replacement of non-conforming materials or the refund of the purchase price, and we bear no liability for consequential, indirect, or incidental damages arising from the subsequent use of the materials.
Are there specific compliance requirements for clients requesting Custom Synthesis?
Yes. Clients requesting Custom Synthesis (CDMO,CMD) or the supply of active pharmaceutical ingredients must ensure they hold the necessary licenses, permits, and regulatory approvals required by their local and national authorities to receive, handle, and utilize the requested chemical compounds. Biosin Pharma strictly adheres to international chemical trade regulations, embargoes, and controlled substance laws. We reserve the right to refuse service or cancel contracts if we determine that the requested synthesis or the ultimate destination of the materials violates applicable international laws or ethical manufacturing standards.
Contact Our Legal Department
For questions regarding these terms or to discuss a formal Service Agreement, please reach out to our registered office.
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- Headquarters: Bangalore, Karnataka, India.
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- Corporate Email: info@biosinpharma.com