Due Diligence (formal exercise of quantifying risks and confirming value) for contract R&D and Contract Manufacturing (CDMO) is an important criteria for defining potential business suitability. This involves critical evaluation of facility, equipment, quality systems and expertise in each functional team in relation to specific needs of the project. With the vast experience of our team and our business associates in this area, we support consulting segments in the area of pharma formulation contract manufacturing, focused product development (R&D) and mapping and identification of academic/research institutions for Discovery services. Our team will guide you through the Due Diligence process with our expertise and commercial awareness to ensure your business operations are compliant and profitable.
Our team at InnovaSMART® acts as a local scouting office to broaden our clients geographical search in mapping and identifying various companies and academic institutions for a better collaboration in the areas of Discovery and / or development and / or manufacturing of pharmaceutical substances, Agrochemical Actives, Specialty Chemicals, any of their respective intermediates and any of their respective Formulations.
In Contract Manufacturing and R&D space for Pharmaceuticals, one needs to be fully compliant with respect to the regulatory needs of the end market. This leads to a process of Due Diligence involving many evaluation steps. InnovaSMART® team has experience in Technical Due Diligence (TDD) of Contract Manufacturing & R&D service providers for meticulous examination of their various technical aspects including product/process technology parameters.
Due Diligence process involves competitive bid selection following SWOT analysis to rank the field factoring in predetermined criteria for identifying two or three companies with whom to schedule visits and decide on the collaborations. Deciding to use CRO/CDMO requires a thorough due diligence exercise with a desktop and onsite reviews as this will have a cascading effect on clients development timeline and lasting impact on the success of the company. This is particularly helpful for overseas clients for balancing resource conservation and saving precious time for objective comparisons.
We also support building an industrial and supply chain management in the area of vendor development for key raw materials (KRMs) and regulatory starting materials (RSMs)