Contract Research and Manufacturing Services (CRAMS)
MBO offers wide range of Contract Research and Manufacturing services in Process Development and on new chemical entity (NCE's) that Covers from Pre-Clinical to commercial Phases.
MBO has a strong Pool-team of scientists are functioning from MBO research center; Which is supported by a highly promising ISO certified manufacturing facility for Regulatory KSM's.
MBO is focusing on strategic cost reduction and transformation for upcoming need of Regulatory KSM's; while delivering commercial value to customers in a CRAMS business-model across the globe. MBO has a proven track record in “chemical process development, investigation and manufacturing” with high quality oriented delivery.
Additionally. MBO has global manufacturing capabilities, and regulations, and is geared up to support and accelerate the development and manufacturing programs of global innovator companies for Novel Chemical Entities (NCEs).
Contract manufacturing of intermediates and API's in kilograms to ton scales (cGMP or Non-GMP).
MBO supports for Impurity Profiling or reference standards for DMF filings.
ROS (Route of Synthesis) design or Route Scouting Services with high efficacy on delivery.
Optimization on synthetic routes, yields and processes development (Tech pack), and process validation followed by commercial manufacturing.
Contract Development and Manufacturing Organization (CDMO)
MBO's chemists and scientists are proficient in various methodologies used for synthesizing compounds and separating enantiomers with the required therapeutic activity from a racemic compound. Asymmetric catalysis, chiral auxiliary and organo-catalysis are some of the asymmetric transformation methods that we used to explore new molecules.
MBO is supporting global clients for their drug candidate to GLP TOX and CDMO with an effective transition from the medical chemistry phase to early scale-up without taking more time than absolutely necessary.
MBO has a strong legacy of services in discovery, development, and manufacturing we are ideally positioned to serve global pharma and specialty companies worldwide. IND/NDA filings.
MBO discovery and development services are offered from a custom development, and manufacturing of clinical compounds to enable your Our end-to-end integrated services offerings range from discovery chemistry, commercial manufacturing facility.
world-class R&D center situated in India and supported by a scale-up services.
While accelerating the R&D programs of our clients, we keep sustainability, quality, environment, health, and safety (EHS) we do quality of work and provide better services.
Chemistry, manufacturing, and controls services (CMC)
MBO Chemistry, manufacturing, and controls (CMC) and contract pharmaceutical laboratory services play an important role and outsourcing support to accelerate and optimize your drug development programs.
CMC plays a main role in all stages of the product life cycle including early and late phases of development and even after marketing authorization when the product is on the market.
CMC covers a wide range of activities including product, process and test method development, product stability testing, phase appropriate validation, and manufacturing and testing under GMP conditions.
MBO’s CMC team can provide you with regulatory strategy advice, scientific/technical writing, and quality variation on a global basis. MBO covers all CMC regulatory tasks from the early development stage.
MBO helps to design and develop an alternative and innovative Route of Synthesis(ROS) for the commercialization of customers required products.
MBO’s CMC services team work closely with customers from pre-stage to post-stage in various stages like, Phase I and II, Phase III, and Post-stage providing guidance and expertise on technical and regulatory considerations.
MBO offers expert consulting services that cover all aspects and stages of Chemistry, Manufacturing, and Controls (CMC) pharmaceutical and biological product development supporting small, midsize, and large (bio) pharma companies.
MBO’s CMC experts can seamlessly integrate with your in-house experts and participate in multi-disciplinary development teams to facilitate your product.