Stabicon Life Sciences is an analytical services company located in Bangalore, India that provides formulation development, analytical development, validation, and stability management programs. It has state-of-the-art facilities for pharmaceutical and nutraceutical product development, analytical services, and regulatory services. Stabicon has expertise in various dosage forms and product categories and aims to be a medium-sized partner for customers' analytical needs.
Formulation Science
Main steps of formulating a Drug Product
The role of Formulation Science in different
stages of Drug Development
Trends and challenges in formulation
development
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!
Xcelience is a contract research organization that has provided formulation development and clinical trial manufacturing solutions for pharmaceutical companies since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Core services include: API Characterization, Analytical Development and Stability Services, Formulation Development, and Clinical Trial Manufacturing, Packaging and Labeling. For more detailed information about Xcelience, visit www.xcelience.com
Formulation Science
Main steps of formulating a Drug Product
The role of Formulation Science in different
stages of Drug Development
Trends and challenges in formulation
development
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!
Xcelience is a contract research organization that has provided formulation development and clinical trial manufacturing solutions for pharmaceutical companies since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Core services include: API Characterization, Analytical Development and Stability Services, Formulation Development, and Clinical Trial Manufacturing, Packaging and Labeling. For more detailed information about Xcelience, visit www.xcelience.com
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is 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.
Hi, I'm Presents a Research article for Journal club entitled with
"3D Printing: A Case of ZipDose® Technology –World’s First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product"
Reference (Source article):
1. West, Thomas & Bradbury, Thomas. (2018). 3D Printing: A Case of ZipDose® Technology - World's First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product: Process Engineering and Additive Manufacturing. https://doi.org/10.1002/9783527813704...
2. https://www.aprecia.com/technology/zipdose
This report provides comprehensive information on the current therapeutic developmental pipeline of Genzyme Corporations, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. It also reviews latest updates, and featured news and press releases, along with special features on late-stage and discontinued projects.
http://www.researchmoz.us/genzyme-corporation-product-pipeline-review-2015-report.html
Pharmaceutical industry is constantly looking for ways to ensure and enhance product safety, quality and efficacy. However, drug recalls,
manufacturing failure cost, scale up issues and regulatory burden in recent past suggest otherwise. In traditional quality by testing (QbT) approach, the product quality and performance are predominantly ensured by end product testing, with limited understanding of the process and critical process parameters. Regulatory bodies are therefore focusing on implementing quality by design (QbD), a science based approach that improves
process understanding by reducing process variation and the enabling process-control strategies. In this regards, pharmaceutical industry is currently undergoing a significant transformation to streamline their R&D process, provide greater manufacturing flexibility and control, and to reduce regulatory burden. However, there is limited understanding and major concerns regarding the implementation of QbD principles in the
pharmaceutical arena. The objective of this review article is therefore to provide a comprehensive understanding on various aspects of QbD, along with addressing the concerns related to its implementation.
The successful development of a biosimilar presents unique challenges compared to that of an innovator biologic. In particular, one must prove the biosimilar candidate's structural and functional differences do not have a meaningful impact on the clinical safety and efficacy profile already established for the innovator. Comprehensive and rigorous analytical testing to assess biosimilarity is thus the foundation upon which the successful development of a biosimilar begins.
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.
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is 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.
Hi, I'm Presents a Research article for Journal club entitled with
"3D Printing: A Case of ZipDose® Technology –World’s First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product"
Reference (Source article):
1. West, Thomas & Bradbury, Thomas. (2018). 3D Printing: A Case of ZipDose® Technology - World's First 3D Printing Platform to Obtain FDA Approval for a Pharmaceutical Product: Process Engineering and Additive Manufacturing. https://doi.org/10.1002/9783527813704...
2. https://www.aprecia.com/technology/zipdose
This report provides comprehensive information on the current therapeutic developmental pipeline of Genzyme Corporations, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. It also reviews latest updates, and featured news and press releases, along with special features on late-stage and discontinued projects.
http://www.researchmoz.us/genzyme-corporation-product-pipeline-review-2015-report.html
Pharmaceutical industry is constantly looking for ways to ensure and enhance product safety, quality and efficacy. However, drug recalls,
manufacturing failure cost, scale up issues and regulatory burden in recent past suggest otherwise. In traditional quality by testing (QbT) approach, the product quality and performance are predominantly ensured by end product testing, with limited understanding of the process and critical process parameters. Regulatory bodies are therefore focusing on implementing quality by design (QbD), a science based approach that improves
process understanding by reducing process variation and the enabling process-control strategies. In this regards, pharmaceutical industry is currently undergoing a significant transformation to streamline their R&D process, provide greater manufacturing flexibility and control, and to reduce regulatory burden. However, there is limited understanding and major concerns regarding the implementation of QbD principles in the
pharmaceutical arena. The objective of this review article is therefore to provide a comprehensive understanding on various aspects of QbD, along with addressing the concerns related to its implementation.
The successful development of a biosimilar presents unique challenges compared to that of an innovator biologic. In particular, one must prove the biosimilar candidate's structural and functional differences do not have a meaningful impact on the clinical safety and efficacy profile already established for the innovator. Comprehensive and rigorous analytical testing to assess biosimilarity is thus the foundation upon which the successful development of a biosimilar begins.
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.
#InvitroStudies are critical to the #drug and #wellness product #development due to their ability to provide a basis for #clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. #Our solution on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology #development of the active process, when the selectively and possible interactions of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established. Our team can provide solution map on case to case basis for your specific requirement . For more details please visit on https://www.stabicon.com/In-Vitro.php
T.Rama Rao is a Sr.Consultant & Promoter of M/s.Saipharma Consultancy with Team Members having rich experience in handlig Project Management, Audits & Compliance Management, Regulatory Affairs, Pharmaceutical Product Development, GxP Training/ Operational Excellence
We work with Micro ,Small ,Medium and Large Enterprises in Pharma Formulations/Intermediates ,APIs,& Chemicals / Medical Devices/ BioTech / AYUSH/ Primary Pkg Mtrs/ Clinical Research Organisation .
Please visit our web site www.saipharmaconsultants.com for further details
Integra gen s.a (alint) product pipeline analysis, 2014 updateAmbikabasa
Summary IntegraGen S.A (IntegraGen) is a biotechnology service provider. The company provides clinical genomic services to academic researchers and life sciences companies. It offers services such as DNA extraction, management samples, study design, strategy, selection markers, tagging, biostatistics analysis, and bioinformatics analysis of sequence data. IntegraGen provides sequencing and genotyping of DNA and RNA. The company offers services in the fields of pharmacogenetics, cytogenetics, epigenetics, and agriculture. It serves patients, clinicians and researchers. IntegraGen partners with illumia, Fluidigm, DNA genotek and Agitent Certified companies.
http://www.researchmoz.us/integragen-sa-alint-product-pipeline-analysis-2014-update-report.html
The Avoca Quality Consortium Summit, held May 8-9, 2013, in
Princeton, NJ, was the Second Annual meeting for The Avoca
Group’s Quality Consortium, a cooperative effort that brings
together quality, outsourcing, and operational professionals
from Member pharma, biotech, and CRO organizations to
accelerate the development of a best-practices approach to
quality management and CRO oversight.
Currently, the Avoca Group’s Quality Consortium includes
26 Members: 16 pharma/biotech companies and 10 Contract
Research Organizations (CROs). The corporate sponsors of the Quality Consortium are Eli Lilly and Company and Pfizer, Inc. ICON Clinical Research was the corporate sponsor of the May Summit.
Special thanks to our Executive Summary Sponsor,
inVentiv Health Clinical.
Food and beverage design consultants like the Food Research Lab offers B2B services in beverage formulation. The team of formulation specialists assist in developing a new drink or mimicking an existing one. They also help in creating new varieties of formulated products.
Concept to commercialization document gives an insight into the basic prerequisites of the technical & commercial process being followed at Stabicon. Its key input includes various segments of unmet needs in the Quality Management and address development, Analytical and services and innovation technology. Also a simplified business model along with our concept to completion laboratory design gives Stabicon additional efficiency & viability to our clients.
Commrcialization is the process of bringing new product to services to market . The broader act of commercializ
Commercialization is the process of bringing new product to services to market. The broader act of commercialization entails production, distribution, marketing, sales, customer support, and other key function critical to achieving the commercial success of the new product or service.
Bhat Bio-Tech India (P) Ltd was incorporated in the year1994 and carved a niche as the known manufacturers and suppliers of Healthcare products for Malaria, HIV, HBsAg, HCV, Syphilis, Chikungunya, Dengue, LH,hCG Card, Glucometer, Blood Test Strips, Urine Test Strips and many more products. Our products are widely known for the features such as superior quality, reasonable prices. Manufactured from superior quality material our range stands high in terms of quality.
A review article on visual inspection program for sterile injectable product ...Palash Das
Objective of this article is to conduct a thorough review and understanding on the manually
conduct visual inspection process for liquid Injectable products in liquid and lyophilized form
and to explore the complications identified during the routine process. Along with that
troubleshot to overcome from the challenges. Evaluation quality of product during batch
release and consider continuous process improvement opportunities.
Companyprofilesandconferences.com glad to promote a new report on "Digna Biotech, S.L. - Product Pipeline Analysis" which are focuses on the development and commercialization of robust clinical therapeutic candidates through partnerships with pharmaceutical companies.
#Stabicon has been ambitiously established in 2010. Stabicon has a broad range of capabilities and networks in the industry with over 100+ clients and 450+ completed projects for improving our industry partners' growth & human health benefits. Our decade-old experience includes supporting pharmaceutical companies & Institutes for #dosage conversion, Process # #health quality, Cost efficiency & Turnaround time for their stringent regulatory markets products filing to get market authorization. we are proud to lay a #foundations for prosperous future in prevention and cure segment, future #medicine & #FMCG business.
For more details please visit on:http://www.stabicon.com/
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3. Overview
Located in Bommasandra Industrial Area, Bangalore,
India.
Established in September 2010
Managed by well experienced professionals in the
business of Formulation Development, Analytical
Development, Validation & Stability Management
Programs.
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
3
5. R & D : Overview
A state-of-art Pharmaceutical & Nutraceutical
development facility for Global markets
Product development as per the Quality by Design
concepts and requirements
Product life cycle management and line extension for
brand products.
Development of Pharmaceutical and Nutraceutical
Formulations in solid, liquid.
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
5
6. R & D : Overview
Analytical Services (Development, Validation, and
Transfer, Impurity Profiling, and ICH Stability Studies)
Patent & Intellectual Property Management (Out
Sourced)
Regulatory Services and Post-Approval Support (Out
Sourced)
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
6
7. R & D : Overview
Technology transfer (product and analytics) from R&D to
pilot-plant to commercial production.
Quality control and assurance capability for batch
releases
Coordination with Manufacturing units for undertaking
large scale batch sizes for registration and/or
commercial batches
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
7
8. Expertise
Solid Oral Dosage Forms
Immediate Release Tablets
Orally Dispersible Granuales
Capsules
Veg Capsules
Tablet / Pellet in Capsules
Liquid Dosage Forms
Liquid Orals
Topical Dosage Forms
Creams and ointments
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
8
11. Formulation Development
Fully equipped Research &
Development laboratories for
product and process
development
Well designed systems for
product
development and documentation
to meet any statutory /
regulatory requirements
throughout the globe
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
11
12. Analytical Development
Caters analytical support for
formulation development, registration
batches, stability.
A dedicated and strong team of 40
people responsible for ensuring quality
submissions
Total 3 laboratory modules:
1.Analytical Method Development
2.Analytical Method Validation
3.Method Transfer and Stability/
Development Support
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
12
13. Regulatory Affairs
CTD dossier format as necessary
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
13
15. Advantage Stabicon
Medium sized Pharmaceutical & Nutraceutical, Formulation
Development
Easy turn around
Speed of response
Proven experience in working with MNCs
Joint development expertise
Independent development expertise
Analytical Development, Validations and Stability
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
15
16. Website
For detailed information & RFQ, please visit our website
www.stabicon.com
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
16
17. Thanks
For any query,
Please contact us at
Stabicon Life Sciences Pvt. Ltd
Plot No. 28,
Bommasandra Industrial Area (Sub-layout),
4th Phase, Jigani hobli, Anekal Taluk,
Bangalore - 560 100 (INDIA)
Phone: +91 80 2783 9259 / 60
e-mail : info@stabicon.com
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
17