Expert Consultation for the Pharmaceutical Industry
At Zehza Life Sciences, we offer specialized consultation services designed to meet the evolving needs of the pharmaceutical and biotechnology sectors. Our team of experts is dedicated to providing comprehensive support across a range of critical areas, ensuring your projects succeed with maximum efficiency and compliance.
Our Core Services
Patent Non-Infringing Strategies (Para IV Filings): Navigate the complexities of patent landscapes with our expert guidance. We help you develop strategies that avoid patent infringement, ensuring your products reach the market smoothly and without legal hindrances.
Scale-Up and Technology Transfer: Efficiently scale-up and transfer technology for all dosage forms. Our experienced consultants assist with every phase of the scale-up process, from initial development to full-scale production, ensuring seamless transitions and optimized processes.
Design and Execution of Validation Batches: Achieve regulatory compliance and product consistency with our tailored validation batch design and execution services. We ensure that every aspect of your batch meets stringent quality standards.
Comprehensive Documentation Preparation: Prepare critical documentation with precision. Our services include:
- Product Development Reports
- Analytical Method Development Reports
- Batch Manufacturing Records
- Batch Packaging Records
- Exhibit Batches Protocol
- Validation Batches Protocol
- Hold Time Study Protocol
- Multimedia Study Protocol
Elemental Impurity and Nitrosamine Risk Assessment: Assess and mitigate risks associated with elemental impurities and nitrosamines. We provide expert support to ensure that your products are safe and compliant with current regulations.
Specification Finalization: Finalize specifications for both drug substances and drug products, tailored to meet regulatory requirements and industry standards.
Quality by Design (QbD) Implementation: Implement Quality by Design principles to enhance product quality and process efficiency. We guide you through the QbD framework to optimize your development processes.
Risk Assessment and Mitigation: Identify potential risks and develop effective mitigation strategies to safeguard your projects and ensure successful outcomes.
Site-to-Site Transfers: Facilitate smooth and efficient site-to-site transfers, ensuring that all processes are seamlessly integrated and maintained.
Cost Savings Assessment: Evaluate client operations to identify opportunities for significant cost savings. Our team helps you optimize processes and reduce expenses without compromising quality.
