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We develop fully integrated, smart and customized CMC development and manufacturing strategies for individual products, programs, or entire portfolios.
We can manage any stage of the drug substance or drug product development process or maintain involved in the development process over multiple development stages.
We have selected, contracted and managed the development work at multiple CDMO and CMOs for our clients in an efficient, transparent and fully accountable manner.
We manage the clinical demand and supply planning including labeling and packaging and delivery to CRO depots of our clients.
We have managed the tech transfer of drug product and drug substance from one manufacturing site to another including international tech transfers.
Through our sister company Cilatus Manufacturing Services, we can handle the QA responsibilities for our clients partially or fully. We have set up complete Quality Management Systems, developed SOPs, audit plans and training systems. We perform QA and Vendor Qualification Audits and can perform QP services as required for our clients.
We oversee the method development effort and QC release testing at external laboratories and CDMOs for our client. We set up and manage clinical in-use studies and complex cell–based potency assays as desired by our clients.
Through our sister company Cilatus Regulatory Services, we integrate our CMC Regulatory expertise into every step of our service work to ensure compliance with current guidelines. We can author INDs, IMPDs and BLAs, prepare for agency meetings, participate in agency meetings and respond rapidly to agency questions in the CMC area.
We can help our clients to develop well-defined scopes, realistic budgets and time lines for their facility project. We can perform conceptual engineering services and then program manage and lead the selection, contracting and management of Engineering, Construction and Validation companies. We have performed Due Diligence services for purchase or lease of manufacturing sites and facilities for clients.
We have analyzed and bench marked technical organizations, management and leadership practice in Development, Manufacturing, QA, QC, and Regulatory Affairs. We have proposed revised organizational models and implemented organizational change for more efficiency, improved organizational health and clarity in leadership. We have guided and coached individuals, departments, and organizations successfully through organizational change.
We can support clients in the due diligence process for partnering, investments and in- and out-licensing of biologic products in the CMC and manufacturing area.