We cooperate with leading Contract Research Organizations operating state of the art facilities. Having access to adequate resources and expertise to offer end to end product development to global healthcare companies.
Services offered are:
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Formulation Development
Product development is our core competency. Having state of the art formulation development / Analytical development /QC lab, GMP scale up manufacturing plant and stability chambers to cater formulation needs under one roof, our work starts with literature search, patent landscaping and strategy development. Based on the formula and process optimization studies using DOE concept, final composition and manufacturing process is suggested for bio-study and scale-up. We operate a FDA approved GMP facility to manufacture scale up / Pilot BE batches to ensure process robustness & reproducibility.
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Flavour Development
We offer consulting services and project management concerning the flavour of products and flavour-influencing processes. Delivering a personalized service and tailored solutions for your technical challenges.
Profit from our broad range of experience in food and beverage technology, and our knowledge of the links between sensory analysis, instrumental analysis and flavour. According to your needs, we develop plans and define the steps, for you to reach your objectives on a efficient and result driven track to success.
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Analytical Development
Our Pharma Research is fully supported by a comprehensive and state-of-the-art Analytical R&D facility to meet the ever rising demands of the global healthcare industry. Experienced scientists and advanced capabilities lead to fast and scientifically sound results.
We support development of drug substance & drug product and focused on accelerating the product development cycle.
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Clinical batch manufacturing
Our Product Development programs rapidly accelerate your product to Pilot BA / BE studies using Process Optimized Formula Composition. We are into manufacturing of GMP Scale up batches to provide a seamless approach through all phases of development and finally to commercialization.
From simplified dosage forms in the earliest clinical pilot BA / BE studies to critical registration / submission / small volume commercial batches are being manufactured by us.
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Stability studies
We employ qualified personnel to conduct stability studies of drug products and substances in compliance with various global regulatory agencies and ICH guidelines.
We operate 100 000 Litres of storage space with walk-in or reach-in stability chambers including refrigerated and freeze thaw conditions as well as photo stability and scalability, with abundant space in the facility to extend to 250 000 Litres if needed.
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All chambers are individually monitored permanently by facility-management datarecording and alarming which complies to US FDA 21 CFR Part11 with back-up units. We provide stability testing to support your regulatory submissions, and ensure accurate evaluation of quality, strength, purity, potency and identity of the products.
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Synthesis of organic compounds
Our team promises timely delivery of technically challenging custom synthesises to fulfill unmet needs of the Healthcare industry. We offer the synthesis of a wide variety of organic compounds ranging from small organic molecules to larger ones from mg to kg.
We will be very pleased to prepare a proposal for the molecules to be synthesized. Refer to the questionaire below.
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Clinical trials
We aim to be a leading Clinical Research Organization for the healthcare industry. We provide comprehensive BA / BE services, Bioanalytical services & Clinical Development for global clients in the pharmaceutical and biotech industries. Our technical expertise, sound service setup, and compliance with major regulations make us to commit deliverables on time, regardless of your project size.
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Our R&D experts strive to provide a high level of technical competence and customer service while maintaining strict adherence to confidentiality and ethical principles. We ensure that every study is conducted in accordance with GCP, GLP guidelines and other applicable regulatory requirements.
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