Regulatory, Quality, and Compliance Services
Zehza Life Sciences, your trusted partner for comprehensive technical and regulatory support. Our team of experts is dedicated to ensuring your operations comply with the highest standards and regulations. Explore our key services below:
Regulatory Strategy Support
Filing of Regulatory Strategy: Expert assistance in developing and filing regulatory strategies to ensure compliance and streamline the approval process.
Interpretation of Regulatory Guidelines: Providing scientific justification and expert interpretation of complex regulatory guidelines to navigate the regulatory landscape effectively.
Deficiency and Query Response: Professional support in addressing regulatory deficiencies and queries with timely and accurate responses.
505(b)(2) Filings: Specialized technical support for 505(b)(2) new drug applications, helping to navigate the complexities of this regulatory pathway.
Validation and Qualification
Equipment Validation: Ensuring that equipment meets required standards through rigorous validation processes.
Process Validation: Implementing and validating processes to ensure they perform consistently and meet quality requirements.
Facility Qualification: Qualification of facilities to ensure they meet necessary regulatory and operational standards.
Auditing and Compliance
cGXP Operations Auditing: Conducting audits of various cGXP operations, including:
- API manufacturing
- Laboratory operations
- Clinical dosage operations
- Commercial dosage operations
- CROs and CMOs
Contract Manufacturing Organization (CMO) Audits: Evaluating the technical and quality systems of CMOs to ensure they meet client-specific requirements.
Investigations and Support
Phase I and Phase II Investigations: Providing support for Out of Specification (OOS) and Out of Trend (OOT) investigations during early-phase clinical trials.
SOP Drafting: Developing Standard Operating Procedures (SOPs) for research and development (R&D) and manufacturing plants.
Contact us today to learn more about how we can assist with your regulatory needs and help bring your product to market with confidence.
