Aizant is a contract research organization that provides integrated drug development solutions including formulation development, analytical development, cGMP manufacturing, and clinical services. It has facilities and capabilities across India that are FDA inspected. Aizant aims to reduce drug development costs by 30-35% through its services while maintaining quality and expediting timelines. It utilizes a project management approach and information technology infrastructure to efficiently execute projects.
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
Established in 2012, EFRAC is a USFDA Inspected & BSE Listed Company having ISO
17025:2005 Accreditation in Chemical & Biological disciplines. Drugs & Cosmetics Division at
EFRAC is and advanced Pharmaceutical Testing Facility with Cutting-Edge Technology, 21 CFR Part
11 enabled & DQ, IQ, OQ, PQ, Qualified Instrumentation. EFRAC conducts a wide range of Tests in
Strict adherence to the Scientifically Approved Protocols and Standards by Drug Regulators like
CDSCO, WHO, MHRA & USFDA.
Scynexis Fully Integrated Drug Discovery & Development 2011 Overviewbrycechaney
SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP manufacturing. We have delivered 11 Preclinical Candidates (PCCs) to our clients since 2005. We are FDA and DEA inspected.
Ask yourself - Do you want compounds... Or do you want DRUGS?
Guide for executives in small and emerging pharmaceutical and biotech companies to select contract development and manufacturing organization (CDMO) and contract research organization (CRO) partners
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
Established in 2012, EFRAC is a USFDA Inspected & BSE Listed Company having ISO
17025:2005 Accreditation in Chemical & Biological disciplines. Drugs & Cosmetics Division at
EFRAC is and advanced Pharmaceutical Testing Facility with Cutting-Edge Technology, 21 CFR Part
11 enabled & DQ, IQ, OQ, PQ, Qualified Instrumentation. EFRAC conducts a wide range of Tests in
Strict adherence to the Scientifically Approved Protocols and Standards by Drug Regulators like
CDSCO, WHO, MHRA & USFDA.
Scynexis Fully Integrated Drug Discovery & Development 2011 Overviewbrycechaney
SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP manufacturing. We have delivered 11 Preclinical Candidates (PCCs) to our clients since 2005. We are FDA and DEA inspected.
Ask yourself - Do you want compounds... Or do you want DRUGS?
Guide for executives in small and emerging pharmaceutical and biotech companies to select contract development and manufacturing organization (CDMO) and contract research organization (CRO) partners
Kemwell provides extensive mammalian cell culture-based formulation development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology-transfers and process characterization.
Innovative Drug Pipeline Solutions: Medicinal Chemistry, Process Chemistry, cGMP API Manufacturing. 105+ global clients. 120,000 sq.ft. facilities located in Research Triangle Park, NC USA. FDA inspected and DEA registered.
We focus on providing you lab testing services that accelerate R&D intensive projects. Follow us to share & learn about analytical testing research and more.
Diteba is a global leader in complex analytical and bioanalytical testing, providing solutions and services to the pharmaceutical, biopharmaceutical and nutraceutical industries.
We support both large and small molecule testing for various dosage forms including solids, semi-solids, liquids, aerosols and other special dosage forms. Our work is focused in several core areas including: In Vitro Release Rate Testing (IVRT) services; stability storage and testing; method development and validation and QC testing at our fully accredited facility.
The Bioprocessing Summit
August 18-22, 2014 | Boston, MA
http://www.bioprocessingsummit.com
The Bioprocessing Summit brings together international leaders to discuss today's bioprocess issues from cell line
selection to bioproduction. The Summit provides practical details in a relaxed, congenial atmosphere that promotes information exchange and networking.
The Bioprocessing Summit continues to grow, and now comprises 12 distinct meetings in one event, including cell
culture, purification, bioproduction, quality, formulation, and novel biotherapeutic formats. The Summit also features small-group breakout discussions, networking in the busy exhibit hall, an extensive poster display, and an array of in-depth short courses and training seminars. For the full listing of speakers at this year's Summit, please click here.
This leading bioprocess meeting is hosted in Boston each summer along the lively and cosmopolitan harbor
waterfront. Hundreds of bioprocess professionals come together each year at the Summit to share practical
solutions for today’s laboratory challenges with researchers from around the world. Please visit the website www.bioprocessingsummit.com for more information and to register.
DCN Diagnostics. Design and Development of Lateral Flow Assay SystemsBrendan O'Farrell
DCN Diagnostics designs and develops rapid assay systems for medical and veterinary diagnostics, bio-defense, agriculture, environmental testing and other market segments. DCN's service offering includes contract assay development, education and training courses in lateral flow technologies, industrial design and mechanical engineering services related to development of related devices for rapid diagnostics. Our specialties include lateral flow, flow through and microfluidic assay formats, and we have developed qualitative, quantitative, visual or fluorescent assay systems. DCN's ISO 9001:228 and EN 13485 compliant quality system is set up to allow us to deliver the full FDA compliant design history file. Our process and unique teams of highly experienced development scientists working alongside our engineering teams allow us to deliver the product, not just the parts. DCN Diagnostics is the sole supplier of cellulose nanobead technology for lateral flow diagnostics outside of Japan and can supply technical consulting and development assistance to companies wishing to develop and manufacture highly sensitive and quantitative lateral flow assays using the NanoAct (tm) beads. Our experience in multiplexing and joint ownership in the Symbolics patents covering aspects of multipex arraying in lateral flow formats allows DCN to assist our clients in creating highly unique and functional assays for any environment or application. DCN also provides our unique UltraGold (tm) colloidal gold for use in lateral flow assays. DCN's 40nm gold colloid is highly controlled, very stable and designed specifically for use in lateral flow and flow through assays.
Alyante is a custom research services organisation that delivers quality research to help improve your research efficiencies. It provides comprehensive end-to-end solutions ranging from chemical and pharmaceutical development to product supply, including complete regulatory support for filing. To enhance your product portfolio, Alyante offers innovative services including NDDS.
Alyante’s array of innovation-based services and commitment to excellence will help you create new value.
Alyante is an assurance of an alliance that strives to keep your research always ahead of the competition through innovation and trust.
Complementary and alternative medicine (CAM) use is common among patients with psoriasis. CAM modalities include traditional Chinese medicine (TCM), herbal therapies, dietary supplements, climatotherapy, and mind/body interventions. In this review, evidence from clinical trials investigating the efficacy of CAM for psoriasis is reviewed. There is a large amount of evidence from controlled trials that have shown that the combination of TCM with traditional therapies for psoriasis is more efficacious than traditional therapies alone. I have tried to analyze where are we i this therapeutic area.
Kemwell provides extensive mammalian cell culture-based formulation development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology-transfers and process characterization.
Innovative Drug Pipeline Solutions: Medicinal Chemistry, Process Chemistry, cGMP API Manufacturing. 105+ global clients. 120,000 sq.ft. facilities located in Research Triangle Park, NC USA. FDA inspected and DEA registered.
We focus on providing you lab testing services that accelerate R&D intensive projects. Follow us to share & learn about analytical testing research and more.
Diteba is a global leader in complex analytical and bioanalytical testing, providing solutions and services to the pharmaceutical, biopharmaceutical and nutraceutical industries.
We support both large and small molecule testing for various dosage forms including solids, semi-solids, liquids, aerosols and other special dosage forms. Our work is focused in several core areas including: In Vitro Release Rate Testing (IVRT) services; stability storage and testing; method development and validation and QC testing at our fully accredited facility.
The Bioprocessing Summit
August 18-22, 2014 | Boston, MA
http://www.bioprocessingsummit.com
The Bioprocessing Summit brings together international leaders to discuss today's bioprocess issues from cell line
selection to bioproduction. The Summit provides practical details in a relaxed, congenial atmosphere that promotes information exchange and networking.
The Bioprocessing Summit continues to grow, and now comprises 12 distinct meetings in one event, including cell
culture, purification, bioproduction, quality, formulation, and novel biotherapeutic formats. The Summit also features small-group breakout discussions, networking in the busy exhibit hall, an extensive poster display, and an array of in-depth short courses and training seminars. For the full listing of speakers at this year's Summit, please click here.
This leading bioprocess meeting is hosted in Boston each summer along the lively and cosmopolitan harbor
waterfront. Hundreds of bioprocess professionals come together each year at the Summit to share practical
solutions for today’s laboratory challenges with researchers from around the world. Please visit the website www.bioprocessingsummit.com for more information and to register.
DCN Diagnostics. Design and Development of Lateral Flow Assay SystemsBrendan O'Farrell
DCN Diagnostics designs and develops rapid assay systems for medical and veterinary diagnostics, bio-defense, agriculture, environmental testing and other market segments. DCN's service offering includes contract assay development, education and training courses in lateral flow technologies, industrial design and mechanical engineering services related to development of related devices for rapid diagnostics. Our specialties include lateral flow, flow through and microfluidic assay formats, and we have developed qualitative, quantitative, visual or fluorescent assay systems. DCN's ISO 9001:228 and EN 13485 compliant quality system is set up to allow us to deliver the full FDA compliant design history file. Our process and unique teams of highly experienced development scientists working alongside our engineering teams allow us to deliver the product, not just the parts. DCN Diagnostics is the sole supplier of cellulose nanobead technology for lateral flow diagnostics outside of Japan and can supply technical consulting and development assistance to companies wishing to develop and manufacture highly sensitive and quantitative lateral flow assays using the NanoAct (tm) beads. Our experience in multiplexing and joint ownership in the Symbolics patents covering aspects of multipex arraying in lateral flow formats allows DCN to assist our clients in creating highly unique and functional assays for any environment or application. DCN also provides our unique UltraGold (tm) colloidal gold for use in lateral flow assays. DCN's 40nm gold colloid is highly controlled, very stable and designed specifically for use in lateral flow and flow through assays.
Alyante is a custom research services organisation that delivers quality research to help improve your research efficiencies. It provides comprehensive end-to-end solutions ranging from chemical and pharmaceutical development to product supply, including complete regulatory support for filing. To enhance your product portfolio, Alyante offers innovative services including NDDS.
Alyante’s array of innovation-based services and commitment to excellence will help you create new value.
Alyante is an assurance of an alliance that strives to keep your research always ahead of the competition through innovation and trust.
Complementary and alternative medicine (CAM) use is common among patients with psoriasis. CAM modalities include traditional Chinese medicine (TCM), herbal therapies, dietary supplements, climatotherapy, and mind/body interventions. In this review, evidence from clinical trials investigating the efficacy of CAM for psoriasis is reviewed. There is a large amount of evidence from controlled trials that have shown that the combination of TCM with traditional therapies for psoriasis is more efficacious than traditional therapies alone. I have tried to analyze where are we i this therapeutic area.
How US pharmaceutical Market behaved during 2008.Why it has behaved like this what it depicts about the future. What the future hold?????????
I have started compiling data since 2006
Going forward i will be uploading three presentation series US PMP 2008, US PMP 2009, US PMP 2010 which will briefly summaries present, past and future of US pharmaceutical market.
Your valuable comments and criticism will be greatly appreciated and will help me in refining my work further.
Please don't hesitate to contact me. My 24 hr Hand phone no. is + 91 963290278
Driving Innovation through Licensing Competitive Intelligence and Big Data…Paragon Solutions
To see the demo, download it here:
http://www.consultparagon.com/webinar-driving-innovation-through-licensing-competitive-intelligence-and-big-data-analytics.html
Today’s pharmaceutical companies are in a competitive brawl to rapidly identify, value and license promising drug candidates from external sources. This requires a significant investment in time and money, with no guarantee of success. To identify product opportunities ahead of a competitor requires a unique blend of competitive intelligence, advanced search and qualification technology, and the ability to quickly and accurately value a potential investment.
In this session, you will learn how to maximize the investment in time spent searching, qualifying and valuing new assets. This approach offers competitive advantage by putting key information used to decide whether to accelerate, abandon or hold on an opportunity at licensing and acquisitions executives’ fingertips.
Dear Sir,
I take pleasure in introducing STABICON LIFE SCIENCES, a focused Analytical Methods Development/Validation & Stability Centre.
Stabicon Life Sciences is a Contract Research Organization. Services provided by Stabicon currently include specialized and focused services for complete stability study management including storage of samples, analysis and preparation of required documentation, associated analytical method development and validations for different phases of drug development program.
We are committed to complete confidentiality and protection of client’s intellectual property. We are committed to quality and reliability of our service. We also remain committed to our customers to deliver on agreed objectives and committed timelines and a promise to ourselves to be a reliable partner fulfilling requirements of our customer’s .Now we have been approved by few National & Multinational companies, who have now placed order with us for conducting stability studies on their products. We have been audited on behalf of Health Canada and have been approved for performing analytical and stability work for Canadian companies. We are also in process getting registration of our company with USFDA as cGMP testing analytical company located outside United States.
We have come across your company as a reputed organisation.We are looking for business partners with whom we can associate by acting as your back office support from India. By doing this it will allow you to allocate your resources for strategic projects. It will also allow you to save on your budgets significantly by taking advantage of Indian costs with International Quality Services offered by Stabicon.You may please visit our website www.stabicon.com for more details.
Looking forward to your response.
Thanking you and assuring our best service at all time.
Regards,
Vijay
Project Director
Stabicon Life Sciences Pvt Ltd
Mobile: +919591974355/080-41714280
www.stabicon.com
Presentation from SIEPON Seminar on 20 April in Czech Republic, sponsored by IEEE-SA & CAG. Opinions presented by the speakers in this presentation are their own, and not necessarily those of their employers or of IEEE.
1. Aizant® Drug Research Solutions
Integrated Drug Development Solutions
We know the right balance
of cost, quality and Innovation|management|process |clinical
www.aizant.com expediency
2. Milestones
US FDA approval ANVISA MoH Turkey
with no 483s approval approval
Beginning of
Formulation
Operation
Aizant WHO
Incorporated Commissioning approval
of cGMP facility
2005 2008 2009 2010 2011
Beginning Of
Clinical operation Recognition of
NABL accreditation
R&D Center by
of Diagnostic Lab
DSI
4. Advantage Aizant
Reduce R&D costs by 30% to 35%.
Save up-to 35 to 37 FTEs annually
Jump start R&D project 4 weeks ahead of your competitor
Realize a team of amazing innovators at 1/4th of your local hourly rate, equivalent, &
extension to your core development team
40%-45% reduction in capital-intensive investment and utilize the saving for mission
critical R&D
We follow Quality by design concept the impact is successful R&D outcome with lesser
no. of experiments
Access smart labs with web-cam enabled facility for remote monitoring of your projects
saving 50% - 55% of travelling cost & time
Aizant operate as full service CRO enabling you save cost, time, and effort for multiple
vendor management
Improve ROI of your R&D budget @ 20-25% YoY utilizing extra 2 hrs of R&D effort due to
time zone difference and 6 day a week work culture
5. SEZ Advantage
Jump start your project 4 weeks in advance to your competitor
&
Give that extra mileage in your Drug R&D effort
60
50
No. of Days
40
30 A R
P L
A I D
20 R
P
I L
10 D
0
Aizant
Other CROs
Aizant can import API & RLD without waiting for import licenses due
to it’s unique VSEZ advantage.
6. Quality
Total quality
SOP
management
Serviceability
Performance Conformance
Statistical Aizant’s
Guideline
methodologies Quality
System
Reliability Durability
Documentation Training
7. CDO: Services
Formulation Analytical
Preformulation Other Services
Development Development
• Solid State • Dry blending • Method • Scale-up and
Characterization • High shear development technology
• Thermal analysis granulation • Method transfer
• Dynamic vapor • Fluid bed validation • Stand alone
sorption granulation • Method stability studies
• Particle size • Roller compaction qualification • Product
analyser • Extrusion • Method transfers registration and
• Viscosity spheronisation • Stability studies regulatory
measurements support
• Wurster coating • Chiral analysis
• Solubility studies • Clinical support
• Spray drying • Microscopy
• Dissolution • Upcoming facility
• Micronization
studies for potent
• Pan Coating substances
• XRPD, SEM, Hot • Encapsulation
stage
microscopy*
8. CDO:Infrastructure
About 40,000 SFT of F&D area scalable to
80,000 SFT at short notice
Conventional dosage form:
Tablet, Capsule, Liquids & Powders
NDDS
ER,CR, MR ,SR dosage
forms, Microencapsulation, MUPS, Gastro retentive system
Topical Dosage Form & Parenteral
dosage forms
-
Nano enabled formulation, Liposomes &
Microsphere
9. Formulation : Accomplishments
Sus Inj CIR
NDA
SMR 5% 3% 13% 6
7%
CMR LCM
16% 56
SIR
ANDA
23% 94
Combi
Product
NCE ER CT 17% IND
10% 3% 3% 10
Legend Legend
SIR Simple immediate release LCM Life Cycle Management
CIR Complex Immediate release IND Investigational New Drug
SMR Simple modified release ANDA Abbreviated New Drug Application
CMR Complex modified release NDA New Drug Application
Suspension Suspensions
Combi Product Combination products
Inj. Injectables
CT Chewable tablets
ER Extended release
NCE New chemical entity
10. cGMP: Services
Scale up Clinical trial material Analytics Other Services
• Scale up of • Investigational • Testing and • Regulatory
formulation drug product release of support
development • Placebo finished goods
products • Encapsulation of • Cleaning
• Manufacturing tablets, multipar validation/
batches for ticulate, capsule process
regulatory s and other solid validation
submissions dosage forms • Microbiology
• Commercial • Comparator • Stand alone
manufacture of manufacturing stability testing
low volume • Clinical
products packaging, blindi
• All kinds of ng, randomizatio
packaging n
11. cGMP – Infrastructure
About 10,000 SFT of cGMP area designed to
meet FDA/MHRA standard
OSHA compliance and other industry
legislations
Flexibility of manufacturing batches
from 0.05 Kg to 80kgs
Class Controlled environment
100,000 Temp : NMT 25±2°C; RH ≤ 55%
Process trains of Solid Orals
- Upt Upto 15 kg
- Upto 100 kg
12. Clinical - Services
Clinical PK
Bioanalytics Diagnostics
Pharmacology &Biostatistics
• Clinical studies for • Method • Study design •Hematology
males, females development and • CRF review •Biochemistry
and special validation • Randomization •Immunology
population • Method transfer schedule •Urine analysis
• BA/BE studies for of drugs in • Statistical analysis •X-ray
global submissions biological matrix & reporting (SAS
• Proof of concept • LCMS-MS and 9.2 and WinNonlin
studies HPLC analysis of 5.2 software)
drugs and • Well trained staff
metabolites in
biological matrix
from clinical trial
13. CRO – Infrastructure
80 bed (2 clinics) facility spread over 28,000
sq feet
In-house NABL accredited clinical
diagnostics laboratory
Bioanalytical laboratories equipped
with 7 LCMS/MS including API 5500
Offsite storage of data for disaster
recovery and business continuity
Volunteer database
Volunteer database
Male: 2000+
Female: 600+
Access to post menopausal women database
14. Clinical: Regulatory approvals
• US FDA audited facility with NO 483s
• ANVISA inspection successfully completed (No
major or critical observations)
• NABL accreditation for clinical diagnostics
• DCGI inspected and approved
• WHO approved
• Turkey MoH approved
• Working on EMEA inspection
16. Project management
• Cross functional project teams from
formulation, analytical, quality and regulatory
departments
• All projects teams are monitored on MS projects
by an experienced project manager
• Metrics based project planning and execution
• Well defined communication systems as decided
at beginning of project
• Good track record of completing projects on time
17. Information technology
• Data-centre with backup and recovery facility
• Offsite data storage for disaster recovery
• IP Cameras for remote virtual monitoring of
projects
• Biometrics for cross-check and validation
• Well defined IT policy for security and access
control
• Metrics based reporting
18. Contacts
Aizant Drug Research Solutions Pvt. Ltd.
Sy. No. 172 & 173, Apparel Park Road,
Dulapally, Hyderabad, India – 500014
Phone: +91 -9177172188
E-mail: info@aizant.com, Website: www.aizant.com