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Formulation Development

KMS has the right equipment, facilities and highly dedicated formulation development specialists to help you to arrive at the optimal dosage form for your API and application. We ensure, any forms we develop are scalable, compliant and commercializable for our customers. We adopt a comprehensive, time-bound strategy in developing stable products that are efficient in all quality aspects. Our formulation development team enables small amounts of drug product materials to be developed using experimental design methodologies supported by testing at every stage with key performance analytics.

We work on our formulation development strategy based on in-depth study of patents, scientific literature, compendia information, critical quality attributes (CQA) and quality target product profiles (QTPP), Formulation & process risk assessment of the respective drug delivery system and nature of the molecule.

We develop optimized processes that ensure smooth commercial manufacturing. We are sensitive in utilising the client investments/budgets to deliver a cost-effective solution for their formulation development needs. We help pharmaceutical companies to successfully resolve their challenging pharmaceutical compounds both in early-phase formulation development and as well as full generic development.

We provide service to formulations completely from sourcing raw materials, to other stages like preformulation, design of experiments as per QbD ( Quality by Design approach), stability studies as per ICH guidance’s, drug excipient compatibility, pilot scale process development.

Oral and Semisolid Dosage Form

KMS develop generic products in oral formulations which are solids, semi-solid and liquids etc. A team of scientists are available, who are expertise in developing different platform technologies. We also cater to design process which are typical wet granulation, dry granulation, Wurster coating, top spray granulation, extrusion and spheronization, multilayer compression, functional and non-functional coating on pellets and tablets, capsule filling, API particle size reduction by air jet mill etc ;

Sterile Products

KMS capability to develop various from of sterile products start from aqueous injection, Non-Aqueous injection, Micro emulsion, Nano Emulsion, Nano suspension, Lyophilised products, Pre-Filled syringe, Infusion Bags, Ophthalmic solution, Ophthalmic emulsion, Ophthalmic suspension, Macro suspension, Microsphere, Liposome and powder for solution for injection.

Apart from general chemical molecule KMS can also able to handle Non-Beta Lactam based products, Atypical B-lactams (Imipenem ,entrapenam, Meropenam), Protein and peptide based products, Anti-cancer products, Hormone based Products.

KMS has expertise in development of Bio-Similar Injection, 505 (b)(2) sterile Products and NCE clinical formulation development.


Analytical Development

Analytical development lab provides a solution for analytical method development and validate the analytical methods. Analytical development offers standalone services and supports formulation development activities. The AD teams are integrated with product development and Quality assurance teams to ensure effective and accelerated product development. Analytical team do the following services.

Analytical method development for finished products and intermediates.
Analytical method validation for finished products
Analytical method transfer
Analytical method verification
Cleaning method development and validation
Evaluation of Elemental impurities as per ICH guidelines
Development stability studies as per ICH guidelines
Pre-formulation studies
Extractables and Leachables Testing
Intrinsic dissolution
Impurity profiling and characterization
Analytical support for regulatory filing

Technology Transfer

We provide end to end support on technology transfer of products from our development lab through scale up till exhibit batches. Team of scientist are available to meticulously plan the scale up activities, monitor execution, identify critical process parameters, establish design space for parameters and troubleshoot. We established commercial scale validation for complex products and supported successful product launch. Alternately KMS has expertise in reviewing site transfer documents, understand the Critical process parameters ( CPP’s), Risk assessment and contract manufacturing organisaion (CMO’s) and transfer products from one site to another flawlessly.

KMS offers the following business models :

Dossier Development
Co-Development – Profit Sharing
Technology Transfer
Commercial Supply
Dossier Compilation