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Analytical Research Consultancy Services
Acquire more about how we can help bring your product to market through our scientific and regulatory consultancy services.
MORE THAN TESTING, LET OUR KNOWLEDGE AND OUR EXPERIENCE WORK FOR YOU
1- GAP ANALYSIS AUDIT SERVICES/THIRD-PARTY AUDIT
Our team simulated inspection or review conducted to assess organization readiness for an actual regulatory audit. Instead of being carried out by regulatory inspectors, a mock audit is led by our auditors.
We Evaluate the Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and other pertinent standards. We proposed CAPA if any deficiencies or areas of non-compliance that necessitate rectification needed before an impending any inspection.
2- Justification and Regulatory Response Services
Appropriate Query responses during Dossier/DMF review and also after any inspections are critical to the future of your organization. Let our consulting team manage the regulatory response, suggest remediation activities, and support you through the development and implementation of Corrective and Preventive Action (CAPA) plans.
3- PHARMACEUTICAL DEVELOPMENT STRATEGY
We provide technical and regulatory strategic planning support during the product’s development, applying “quality by design” principles and helping clients get the most from their CMO/CDMO/CPO relationships. Our experts can help ensure the manufacturing process is optimized and development moves efficiently forward towards regulatory submission with a product of consistent quality and performance.
4- ANALYTICAL METHOD DEVELOPMENT AND VALIDATION STRATEGY
Product analysis requires a range of specific analytical methods that give highly accurate results with sufficient sensitivity to give insight at low LOQ levels. Our chemistry consultants work with our scientific development team and in-house toxicologists to ensure all the methods are available to:
5- Testing and Quality Controls
Maintaining quality and consistency at life cycle of the pharmaceutical product development, Regulatory filing, commercial manufacture, is essential for regulatory compliance.
Manufacturing, and Controls verify that the product is safe and effective, ensuring reproducibility of batches.
we offer chemical consultancy to ensure the validated methods and technologies used in your project’s trial and testing phase are transferred to Quality Control (QC) for commercial manufacture. Our mission is to solve complex products problems by providing expert consultation services to provide you with accurate solutions.
6- CLEANING VALIDATION
Cleaning validation is the process of ensuring that the cleaning procedures for manufacturing equipment effectively prevent product contamination. Therefore, it is essential to document cleaning validation thoroughly to demonstrate compliance with Current Good Manufacturing Practice (CGMP) for finished pharmaceuticals. Our experts have vast experience in developing cleaning validation protocols that meet both regulatory standards and client expectations.
7- SOP DEVELOPMENT AND IMPLEMENTATION
Operating procedures must be well-defined and specific to your organization. our consulting team can visit your facility, assess your current processes, and create written procedures in line with the regulatory requirements and ensuring that all person of your team trained and execute your written procedures.
