QMS Implementation, improvement & optimization
We support organizations in designing, implementing and strengthening fit for purpose Quality Management Systems.
Our experts support your organization in designing and implementing a tailored Quality Management System that meets your organization’s needs, strategy, regulatory environment and size including : policies, corrective actions preventive actions (CAPAs), Deviations, change and risk management, suppliers and service providers control policy.
We provide guidance to strengthen your existing Quality Management system.
QMS Auditing
We support organizations in designing, implementing and strengthening fit for purpose Quality Management Systems.
Our experts support your organization in designing and implementing a tailored Quality Management System that meets your organization’s needs, strategy, regulatory environment and size including : policies, corrective actions preventive actions (CAPAs), Deviations, change and risk management, suppliers and service providers control policy.
We provide guidance to strengthen your existing Quality Management system.
QMS documentation system development and review
We design robust and tailored documenation system that reflects your internal processes including policies, master plans, site master file, procedures, instructions, protocols, reports, batch records…
Quality system training
We deliver custom-designed personnel training in all fields related to quality Management system to help deploy qualiy culture at all levels.
Compliance and Technical Assistance for development
Quality by design
We support the development of small molecule and biotherapeutic products by integrating quality and regulatory requirements from early development .
Our experts support you to expedite the development and approval of small molecules medicines as well as biotherapeutics by navigating technical, quality and Regulatory challenges and ensuring compliance the whole way to produce safe, effective, and high-quality medicines.
Our services range from defining target product profile (TPP) and critical quality attributes (CQA), process development and pilot scale validation, control strategy choice, analytical development and validation, stability studies design.
Technology transfer
Our experts can lead or support the technology transfer programs applied to processes and know-how from devolpment to production, as well as analytical transfer, whether internally or from an external partner.
These services include coordination, transfer documentation generation, process validation, in line with international standards.
Biosimilars development
We provide pragmatic support for biosimilar development, formulation, fill and finish support. These services encompass activities ranging from strategy planning to capacity-building, product formulation and quality control, comparability studies design, process validation, technology transfer to commercial scale manufacturing.