Manufacturing Scale Up and Process Development
At Apurun, we excel in manufacturing scale-up and process development, ensuring a seamless transition from laboratory-scale to commercial-scale production. Our team of experts works closely with clients to develop scalable and robust manufacturing processes that meet industry standards and regulatory requirements. Key services include:
- Process Optimization: Fine-tuning of existing processes to enhance efficiency and product quality.
- Scale-Up Studies: Conducting studies to ensure processes are scalable and reproducible at larger volumes.
- Technology Transfer: Seamless transfer of technology from development to manufacturing, minimizing risks and ensuring consistency.
- Pilot Production: Small-scale production runs to validate processes and produce material for further testing.
Analytical Methods Transfer and GMP Development
We provide comprehensive support for the transfer of analytical methods and GMP development, ensuring that methods are robust, reliable, and compliant with regulatory standards. Our services include:
- Method Transfer: Transferring validated analytical methods from development to manufacturing, ensuring reproducibility and accuracy.
- Method Development: Creating and optimizing analytical methods to meet specific project requirements.
- GMP Development: Developing GMP-compliant methods for quality control and assurance.
- Validation: Comprehensive validation of analytical methods to ensure they meet regulatory standards.
Stability Studies Program
Our stability studies program is designed to assess the shelf-life and stability of pharmaceutical products under various conditions. We provide detailed data and analysis to support regulatory submissions and ensure product quality throughout its lifecycle. Our services include:
- Stability Testing: Conducting long-term and accelerated stability studies to evaluate product stability.
- Storage Conditions: Assessing the impact of different storage conditions on product quality.
- Data Analysis: Providing detailed analysis and interpretation of stability data.
- Regulatory Support: Assisting with the preparation of stability reports for regulatory submissions.
Regulatory Compliance and Documentation
Ensuring regulatory compliance is a critical component of our technology transfer services. We provide comprehensive support for the preparation and submission of regulatory documents, ensuring that all processes and products meet the required standards. Our services include:
- Documentation Preparation: Preparing detailed and accurate regulatory documents for submissions.
- Regulatory Strategy: Developing regulatory strategies to ensure compliance and streamline approvals.
- Audits and Inspections: Supporting clients during regulatory audits and inspections.
- Compliance Training: Providing training on regulatory requirements and best practices.
Quality Management Systems Implementation
We offer expert support for the implementation of quality management systems (QMS) to ensure consistent product quality and compliance with regulatory standards. Our services include:
- QMS Development: Designing and implementing robust quality management systems tailored to client needs.
- Process Documentation: Creating comprehensive documentation for all quality processes and procedures.
- Continuous Improvement: Implementing continuous improvement initiatives to enhance product quality and efficiency.
- Training Programs: Providing training on QMS principles and practices to ensure effective implementation.
IND Submission Preparation and Regulatory Compliance
Our team provides comprehensive support for Investigational New Drug (IND) submission preparation and regulatory compliance. We ensure that all documentation and processes meet the stringent requirements of regulatory agencies, facilitating a smooth approval process. Our services include:
- IND Preparation: Preparing and compiling all necessary documents for IND submission.
- Regulatory Liaison: Acting as a liaison with regulatory agencies to address any questions or concerns.
- Compliance Review: Conducting thorough reviews of all documentation to ensure regulatory compliance.
- Submission Strategy: Developing strategies to streamline the submission process and expedite approvals.
Technology Transfer
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Manufacturing Scale Up and Process Development
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Analytical Methods Transfer and GMP Development
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Stability Studies Program
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Regulatory Compliance and Documentation
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Quality Management Systems Implementation
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IND Submission Preparation and Regulatory Compliance
Manufacturing Scale Up and Process Development
At Apurun, we specialize in scaling up manufacturing processes to meet commercial demands. Our team of experts ensures that your processes are efficiently scaled while maintaining product quality and compliance with regulatory standards. We offer comprehensive services that include process optimization, equipment selection, technology transfer, and validation. Our goal is to help you transition seamlessly from small-scale production to full-scale manufacturing, ensuring that your products are produced consistently and cost-effectively.
Start NowAnalytical Methods Transfer and GMP Development
Our Analytical Methods Transfer and GMP Development services are designed to ensure that your analytical methods are robust, reliable, and compliant with Good Manufacturing Practice (GMP) standards. We assist in the transfer of analytical methods from development to production, ensuring accuracy and reproducibility. Our services include method validation, stability testing, and quality control, ensuring that your products meet all necessary regulatory requirements.
Start NowStability Studies Program
Stability studies are crucial for determining the shelf life and proper storage conditions of pharmaceutical products. At Apurun, we offer a comprehensive Stability Studies Program that includes real-time and accelerated stability testing. Our state-of-the-art facilities and experienced staff ensure that your products are tested under various environmental conditions to assess their stability and identify any potential degradation products. This information is essential for regulatory submissions and ensuring product efficacy and safety.
Start NowRegulatory Compliance and Documentation
Regulatory compliance and thorough documentation are critical for the success of any pharmaceutical product. Apurun offers comprehensive support to ensure that all regulatory requirements are met and that documentation is complete and accurate. Our services include regulatory strategy development, submission preparation, and liaison with regulatory authorities. We help you navigate the complex regulatory landscape, ensuring that your products are approved and remain compliant throughout their lifecycle.
Start NowQuality Management Systems Implementation
Implementing a robust Quality Management System (QMS) is essential for maintaining high standards in pharmaceutical manufacturing. Apurun provides comprehensive QMS implementation services, including the development of quality policies, procedures, and documentation. Our experts ensure that your QMS complies with international standards such as ISO 9001 and GMP. We provide training and support to ensure that your staff is fully equipped to maintain and continually improve the quality system.
Start NowIND Submission Preparation and Regulatory Compliance
Preparing an Investigational New Drug (IND) application is a critical step in the drug development process. Apurun offers expert assistance in preparing and submitting IND applications, ensuring that all regulatory requirements are met. Our services include the preparation of preclinical and clinical data, manufacturing information, and safety assessments. We also provide ongoing regulatory support to ensure compliance throughout the clinical trial phases. Our goal is to help you achieve successful IND approval and advance your product to market.
Start Now