Small Molecule Development: Quality Assurance and Regulatory Support
Biosynth is a global partner for the development and manufacture of critical raw materials and small molecules NCEs used across pharma and diagnostics.
When searching for a partner for supply of complex small molecules or for development of small molecule NCES, one of the most important aspects for pharma or diagnostics organisations is the quality culture. Ideally, culture is based on quality, and spans across all departments, sites or operating organisations.
Biosynth provides outstanding complex chemistry manufacturing services, from small-scale custom synthesis to large-scale bulk manufacture and for GMP products. For all our custom manufacturing customers, we work as your partner, with a dedicated account manager to ensure effective communication and peace of mind during the entire project lifecycle.
Quality Assurance for Complex Chemicals
Our experienced QA team is responsible for supervising the quality and performance of all business and manufacturing processes and for maintaining our global ISO certification. We have an innovative embedded quality management system and perform regular internal audits. We look to continuously adapt processes to the requirements of the market and ensure consistent compliance at all stages of the supply chain. Special attention is given to compliance issues, in particular API manufacturing, testing, and handling, change control requirements, method and process validation, controlled substance handling, and proper documentation. Our in-house Qualified Person (QP) is able to certify batch release on products from our Swiss GMP site.
Regulatory Assistance
Whether working to ISO 9001 or to GMP, compliance with the latest regulations that apply to your product is essential. Our experienced quality team works with you to ensure that you get the quality standard and documentation that you need.?GMP regulations apply across the entire cGMP service, from manufacturing, QC, filling, packaging, and warehousing. We are experienced with the development and validation of many API processes that have been through various stages of regulatory approval and are proud to have an excellent inspection record.
Our team works with our customers to meet their quality and regulatory needs and are pleased to be able to offer regulatory filing assistance. Whether for preparation or review, we are experienced in working in the eCTD format.
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Bulk and Custom Raw Materials Supply
As a leading supplier of critical complex chemical intermediates, process materials and excipients to the pharma industry, the quality and documentation of these products is vital.
Understanding the Essence of Batch Records
The document contains all relevant information for every batch or lot. It is like a fingerprint, and permits the correct identification of different batches. The following are the fundamental components forming the backbone of these records that ensure precision, compliance, and product integrity.
Batch records are crucial for quality control, regulatory compliance, and traceability. They provide a comprehensive history of each batch, which is important for ensuring product consistency, identifying issues, and meeting regulatory requirements. In regulated industries like pharmaceuticals, adherence to batch record documentation is often a legal requirement.
We not only produce accurate batch records for products we make, but also develop robust manufacturing processes for complex intermediates and drug substances with detailed development and manufacturing reports that help smoother future tech-transfers.?We pride ourselves on crafting precise batch records for every product, ensuring not just compliance but excellence.?