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Analytical and QC
Quality Control and Quality Assurance Services
At Serán BioScience, we understand the critical importance of maintaining exceptional quality standards in every aspect of our operations. Our comprehensive Quality Control (QC) and Quality Assurance (QA) services are designed to uphold the highest levels of product quality, regulatory compliance, and customer satisfaction throughout the CDMO process.
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Quality Control
Our QC services encompass a wide range of analytical and testing procedures aimed at ensuring the integrity, purity, and potency of pharmaceutical products. Our state-of-the-art laboratories are equipped with cutting-edge instrumentation and manned by highly skilled scientists and technicians who execute a variety of QC tests, including:
- Raw Material Testing: We rigorously assess the quality and purity of raw materials to ensure they meet predefined specifications and regulatory requirements.
- In-process Testing: We conduct thorough evaluations at various stages of the manufacturing process to identify and address any deviations or anomalies promptly.
- Finished Product Testing: Our comprehensive analysis of finished products ensures compliance with regulatory standards and confirms product efficacy, stability, and safety.
- Stability Studies: We perform extensive stability testing to evaluate the long-term viability and shelf-life of pharmaceutical formulations under various environmental conditions.
- Quality Assurance Support: Our QA team works closely with our clients' quality assurance (QA) personnel to address any quality-related issues and ensure compliance with regulatory requirements throughout the product lifecycle. We provide comprehensive support, including documentation review, audit preparation, and regulatory submission assistance.
Quality Assurance
Our QA services are integral to the overall quality management system and regulatory compliance framework. We adhere to stringent QA protocols to monitor and uphold the quality of processes, procedures, and documentation throughout the CDMO lifecycle. Our QA initiatives include:
- GMP Compliance: We maintain strict adherence to Good Manufacturing Practices (GMP) guidelines to uphold product quality, safety, and consistency.
- Documentation Control: We oversee the creation, review, and management of essential documentation, including batch records, SOPs, and batch certifications (COAs, COCs), to ensure accuracy, completeness, and traceability of records to support client regulatory submissions.
- Regulatory Compliance: We provide expert guidance and support to ensure compliance with global regulatory requirements, including FDA, EMA, and ICH guidelines.
- Quality Assurance Support: Our QC team works closely with our clients' quality assurance (QA) personnel to address any quality-related issues and ensure compliance with regulatory requirements throughout the product lifecycle. We provide comprehensive support, including documentation review, audit preparation, and regulatory submission assistance.
Why Choose Serán BioScience for QC and QA Services?
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- Expertise: Our team of experienced scientists, analysts, specialists, and quality professionals possesses a wealth of knowledge and expertise in pharmaceutical development and manufacturing.
- Comprehensive Solutions: We offer end-to-end QC and QA solutions tailored to meet the unique needs and requirements of CDMO clients across diverse therapeutic areas and dosage forms.
- Regulatory Excellence: With a deep understanding of regulatory requirements and industry best practices, we help clients navigate complex regulatory landscapes and achieve regulatory approval efficiently.
- Commitment to Continuous Improvement: We are dedicated to continuous improvement and invest in ongoing training, technology upgrades, and process optimization to enhance the quality and efficiency of our QC and QA services.
- Commitment to Quality: We are committed to delivering uncompromising quality, reliability, and transparency in every aspect of our QC and QA services, ensuring the integrity and safety of pharmaceutical products.
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