Pharmaceutical Product Development
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Warm Greetings from Chempro Pharma! Here is a brief presentation regarding our newest project/service offering - pharmaceutical product development. We have a highly specialized team that has worked with the likes of Novartis, Merck and many more market leaders within the pharmaceutical industry. Feel free to review this attachment and contact us at pharma@chemprogroup.net if you have any questions, thanks!
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Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
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EirGen Pharma, based in Waterford, Ireland, is currently recruiting for quality control chemists, analytical development chemists, regulatory affairs officers, and QA officers. EirGen is the supply chain and R&D center of excellence for OPKO Health, exporting medicines to over 45 countries worldwide. The company employs over 170 people from 9 nationalities and offers a competitive benefits package.
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Product development and technology transfer M pharm
1. The document discusses technology transfer in the pharmaceutical industry, which refers to transferring details about formulations and analytical methods from research and development to production. This includes transferring a drug product from laboratory scale to production scale.
2. It outlines the goals, objectives, methods, and importance of technology transfer. The key methods are licensing and technology transfer involves a framework including a feasibility study, scale-up, validation, and production batches.
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Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
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Recomendamos muito.
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Esta publicação só está disponível em inglês até o momento.
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Pharmaceutical Product Development
- 1. Pharmaceutical Product Development An End to End Technology Offering CHEMPRO PHARMA PRIVATE LIMITED Superior Quality Higher Affordability Reliable Service
- 2. Disclaimer ❖ Kindly Note: ❖ Data / Information shared in this presentation is based on the best of knowledge and belief of the team. However we do not claim that the data is completely accurate or updated. ❖ Numbers / statistical figures presented are best estimates. We believe that there can be 10% variations. ❖ This document is meant for PRIVATE CIRCULATION only. Thus this document should not viewed as an official publication of any sort. ❖ This document belongs to Chempro Pharma Pvt. Ltd. and hence this document shall not be shared either in complete or parts to any other party / entity without prior permission. ❖ This is a CONFIDENTIAL document.
- 3. Our Introduction ❖ A highly experienced team with proven expertise in developing and commercializing Pharmaceuticals ❖ The team has experience of providing product development services to Global Players like Novartis, Merck, GSK… ❖ We are a TEAM of PROFESSIONALS comprising of: ❖ Product Development Scientists (R&D) ❖ Analytical Experts (R&D) ❖ Execution leaders (Project management & Tech Transfer) ❖ Commercialization Professionals (QA ,RA & Business Development)
- 4. Our Value Proposition ❖ Process / product development of lab infrastructure which is in operation. ❖ Equipments and instruments required to develop complex APIs swiftly for an affordable price. ❖ Process technology for several APIs. ❖ Experienced manpower for Formulation Development. ❖ Capability to match regulated market requirements.
- 5. Our Value Proposition Infrastructure Process 1) Well Equipped Laboratory. 2) DST Approved. 3) Regulatory & Safety Complaints (EMEA/FDA). 1) Low R&D Cost. 2) Efficient Process. 3) Scalable & Sustainable. 4) IP Compliants. Tech Transfer Team 1) Quick TAT (Ready to transfer technology). 2) Material sources that are already identified. 3) Efficient manufacturing process. 1) Amongst the best in bringing the product to market. 2) Worked in present market leader companies. 3) Experienced in offering end to end solutions beginning from patent search to final product technology.
- 6. Product Technologies Available No. Product Assigned Thru Agreement Alternate Route Possible Timeline (in months) 1 Aripiprazole Yes Yes 4 2 Sertraline HCl Under Development 4 3 Atomoxetine HCl Yes Yes 5 4 Saxagliptin Under Development 5 5 Sitagliptin Phosphate Yes Yes 4 6 Dapagliflozin Yes Yes 4 7 Dasatinib Yes Yes 4 8 Gefitinib Yes Yes 5
- 7. Product Technologies Available No. Product Assigned Thru Agreement Alternate Route Possible Timeline (in months) 1 Sunitinib Yes Yes 4 2 Sorafenib Under Development 5 3 Carmustine Yes Yes 4 4 Pemetrexid Under Development 5 5 Abiraterone Acetate Under Development 4 6 Dexlansoprazole Under Development 6 7 Clopidogrel Yes Yes 4 8 Tramadol HCl Yes Yes 3
- 8. Why Choose Chempro? ❖ People, Process & Projects - Ready. ❖ Our Output Matches the Best Quality Standards. ❖ In-House IP Evaluation Team. ❖ Complete Formulation Development Capability. ❖ Collaboration with SDTI; California.
- 9. Our Capabilities ❖ Custom Synthesis. ❖ API Development. ❖ Analytical Development. ❖ Process Technology Transfer. ❖ Formulation Development.
- 10. THANK YOU! CHEMPRO PHARMA PRIVATE LIMITED We guarantee superior quality, competitive prices and timely delivery for your shipments from India. We are happy to serve your needs!