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.
Framing is a critical piece in ensuring the right segments and needs are being satisfied. This white paper explores our technique to identify and organize around such.
New Product Development Philosophy IB Work BetterStephen Tavares
This presentation outlines Philosophy IB's offerings in the New Product Development space including governance and process design and outsourced project management.
Framing is a critical piece in ensuring the right segments and needs are being satisfied. This white paper explores our technique to identify and organize around such.
New Product Development Philosophy IB Work BetterStephen Tavares
This presentation outlines Philosophy IB's offerings in the New Product Development space including governance and process design and outsourced project management.
Profitiviti - New Product Development Case Study ExampleSteve Raack
The New Product Development (NPD) process is a critical enterprise process for most product / service related companies. Understanding the true costs and talent associated with the NPD process can improve operational efficiencies and profitability. Let us know what you think.
New Product Development was a 3-day public workshop for managers offered for many years through what is now UW-Madison’s Center for Professional and Executive Development (CPED). Since CPED has modified its mission to focus on leadership and management training, this and other marketing classes have been discontinued. Therefore I am providing this for your individual education.
A version of this presentation with embedded hyperlinks to YouTube videos and other educational sites is available through my website, BrainSnacksCafe.com.
Enjoy!
The Critical Role of Sales Throughout the New Product Development ProcessGreg Bonsib
The sales team has a critical role at every stage of the NPD process. So does product marketing. These roles are very different and each crucial to the ultimate product commercialization success in the marketplace.
New Product Development Tools and Techniques SurveyDayu Tony Jin
This is the questionnaire that I developed for one of my market research research project. Various techniques have been incorporated to improve response rate. For details, please visit: http://servicesresearch.blogspot.sg/2010/10/research-methogology-course-summary-2.html
BioTech Journey through the Phases of Commercializing a ProductCBG Benefits
This presentation was delivered by Breck Arnzen of the ArnzenGroup and Susan Nemetz of The NemetzGroup at the HR BioTech Connect Group meeting in January 2013.
They shared a variety of guidance to help companies navigate the process of commercializing a product in the BioTech industry.
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.
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.
Profitiviti - New Product Development Case Study ExampleSteve Raack
The New Product Development (NPD) process is a critical enterprise process for most product / service related companies. Understanding the true costs and talent associated with the NPD process can improve operational efficiencies and profitability. Let us know what you think.
New Product Development was a 3-day public workshop for managers offered for many years through what is now UW-Madison’s Center for Professional and Executive Development (CPED). Since CPED has modified its mission to focus on leadership and management training, this and other marketing classes have been discontinued. Therefore I am providing this for your individual education.
A version of this presentation with embedded hyperlinks to YouTube videos and other educational sites is available through my website, BrainSnacksCafe.com.
Enjoy!
The Critical Role of Sales Throughout the New Product Development ProcessGreg Bonsib
The sales team has a critical role at every stage of the NPD process. So does product marketing. These roles are very different and each crucial to the ultimate product commercialization success in the marketplace.
New Product Development Tools and Techniques SurveyDayu Tony Jin
This is the questionnaire that I developed for one of my market research research project. Various techniques have been incorporated to improve response rate. For details, please visit: http://servicesresearch.blogspot.sg/2010/10/research-methogology-course-summary-2.html
BioTech Journey through the Phases of Commercializing a ProductCBG Benefits
This presentation was delivered by Breck Arnzen of the ArnzenGroup and Susan Nemetz of The NemetzGroup at the HR BioTech Connect Group meeting in January 2013.
They shared a variety of guidance to help companies navigate the process of commercializing a product in the BioTech industry.
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.
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 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 spans 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. 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/
#Stabicon product certification process management strives to improve processes and align the needs of regulatory with client objectives on quality product distribution channel. This gives transparency to the process making it more efficient. It include review and testing process to validate that certified products meet certain standards and comply with a stated designed specification/requirement. Product certification process works towards improving efficiency across the various project stakeholders by helping product evaluation and implement best practices.
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
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
Master of Good Manufacturing Practice - Course Detailsutspharmacy
Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
Working in the Food Processing & confectionary industry. Skilled in Research and Development, Food regulations, Sensory Evaluation, GMP and Quality Assurance. Strong quality assurance.
Mastering the Product Development Process: A Comprehensive Guide to Bringing ...CIO Look Leader
Key Stages of the Product Development Process: 1. Idea Generation 2. Concept Development and Screening 3. Market Research 4. Prototype Development 5. Testing and Validation
Similar to Concept to Commercialization Health & Wellness Product (20)
Biopharmaceutical include vast range of proteins which can be modified at a molecular level and used in artificial vaccines, nutraceutical products and various product on a large scale.
n Ayurveda, withania is widely claimed to have potent aphrodisiac, sedative, rejuvenative and life prolonging properties. It is also used as a general energy-enhancing tonic known as Medharasayana, which means 'that which promotes learning and a good memory' and in geriatric problems.
A growth strategy is an organization's plan for overcoming current and future challenges to realize its goals for expansion. Example of growth strategy goals include increasing market share and revenue, acquiring assets, and improving the organization's products or services.
#FormulationDevelopment is as much an art as it is a science, and it's the people that make the difference. Each of the technologies we work with has application two or more dosage forms and multiple routes of administration. Of course, we have all the analytical and production support needed to advance these products into the clinic. For more details please visit on: http://www.stabicon.com/formulation_Development.php
#Imported or Locally Manufactured #medicines without proper pre & post inspection may be rendered substandard at any point along the #medical supply chain, from the point of manufacture through the point of distribution. Regardless of where along the supply chain substandard #medicines are compromised, they pose serious public health risks. for more details please visit on:http://www.stabicon.com/
#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
Stabicon Life Sciences’ Innovative Solity 3p™* proprietary product technology platform. It enables a wide set of industry and function specific solutions that allows our customers to elevate productivity and create value.
In vitro studies are critical to 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 selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established.
Orally Inhaled & Nasal Drug Products: delivery systems, components and specialist services for a growing industry sector” This edition is one in the series of ONdrugDelivery publications.
Nutraceutical product is a food or fortified food product that not only supplements the diet but also assists in treating or
preventing disease (apart from anemia), so provides medical benefits. Nutraceuticals are not tested and regulated to the extent of pharmaceutical drugs…
In Ayurveda, Withania is widely claimed to have potent aphrodisiac, sedative, rejuvenative and life prolonging properties. It is also used as a general energy-enhancing tonic known as Medharasayana, which means ‘that which promotes learning and a good memory’ and in geriatric problems .
Imported or locally manufactured medicine without proper & post inspection may be rendered substandard at any point along the medical supply chain, from the point of manufactured the point of distribution. Regar4dless of where along the supply chain substandard medicines are compromised, they pose serious health risks.
We express our gratitude and thank you for being the part of our journey through 10 years. without it would not have been possible. We believe in touching lives by providing good quality of life and wellness. You are the witness to our diversification and venturing into future segments of therapeutic and FMCG.
Biopharmaceutical include vast range of proteins which can be modified at a molecular level and used in artificial preparation of vaccines, nutraceutical products and various products on a scale. Biopharmaceuticals are usually derivatives of natural human proteins, which make them ideal for targeted cellular therapy. Unlike small molecule drugs, which penetrate cell membranes including healthy cells, Biopharmaceuticals act through external cellular binding to induce the desired cellular response.
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.
Ability to work in joint ventures and across divisions, culture and countries. Ability to integrate an understand of IP. Scientific expertise and business strategy. Ability to spur creativity while managing commercially. Expertise in functioning and decision making of regulatory requirement. Human resource skills to transform pharmaceutical segment. Dedicated support systems for web interface with real time information. Quality system must meet regulation in multiple markets plus clients internal standards.
Stabicon has evolved with vast experience in working with MNCs and diversified its business portfolio into specialization in managing product quality process, upgrading, introducing advanced technology into products and manufacturing. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. For more details please visit the link http://www.stabicon.com/blog/2020/11/13/strategic-growth-process/?preview_id=106&preview_nonce=7affa7312c&preview=true
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
QA Paediatric dentistry department, Hospital Melaka 2020Azreen Aj
QA study - To improve the 6th monthly recall rate post-comprehensive dental treatment under general anaesthesia in paediatric dentistry department, Hospital Melaka
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
We understand the unique challenges pickleball players face and are committed to helping you stay healthy and active. In this presentation, we’ll explore the three most common pickleball injuries and provide strategies for prevention and treatment.
Navigating the Health Insurance Market_ Understanding Trends and Options.pdfEnterprise Wired
From navigating policy options to staying informed about industry trends, this comprehensive guide explores everything you need to know about the health insurance market.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
2. Concept to Commercialization - Product Email: info@stabicon.com
Confidential Document www.stabicon.com Page: 2
1. Introduction 03-04
2. Quality Approval 05-05
3. Regulatory and Supply network 06-06
4.Operational Portfolio 07-08
5.Development Strategy 09-15
5a. Unmet Needs 16-16
6. Business Model 17-17
7. Formulation and Development division 18-18
7a. Capacity and Capability 19-21
7b. Client scope in product development activity 22-22
7c. Formulation development business development 23-24
7d. Product Development Approach 25-25
7e. Formulation development work flow 26-26
7f. Product development risk analysis 27-27
7g. Generic formulation development timelines 28-28
7h. Development activity milestone 29-29
7i. Upgradation of existing formulation dev cycle –template 30-31
8. Technology checklist 32-36
8a. Generic product pipeline and its status
8b. Innovation pipeline and its status
9. QMS 37-38
10. CTD Dossier 39-40
11.Alliance model case study 40-41
3. Concept to Commercialization - Product Email: info@stabicon.com
Confidential Document www.stabicon.com Page: 3
1. Introduction:
STABICON is a focused research Organization, specialized in the area of Formulation Development (OTC & supplement), Laboratory, In-Vitro and
Technology Development. Lyrus is group company and focus on prescription product development, clinical supply, Clinical Studies & filing and
supply globally
Corporate office is located at
Stabicon Life Sciences Private Limited.
3BM – 416,3rd Block, HRBR Extension,
Bangalore – 560043, Karnataka, India
email: info@stabicon.com
Research Development Center is located at
Stabicon Life Sciences Private Limited.
Plot No. 28, Bommasandra Industrial Area (Sub-layout),4th Phase, Jigani hobli, Anekal Taluk, Bangalore - 560 100, Karnataka, India
Tel. no: +9180-27839259/60
email: info@stabicon.com
4. Concept to Commercialization - Product Email: info@stabicon.com
Confidential Document www.stabicon.com Page: 4
Karnataka State, India: Historical Building
5. Concept to Commercialization - Product Email: info@stabicon.com
Confidential Document www.stabicon.com Page: 5
Stabicon is incorporated in accordance with the laws of India, under the Companies Act, 1956, (No 1 of 1956) with Certificate of Incorporation
“corporate identity number U73100KA2010PTC052428” 2009-2010.Our Company D & B D-U-N-S Number :65-049-0621
The laboratory is registered with the Food & Drug administration, Karnataka as per the Indian Drugs & cosmetics Act 1940. The laboratory has been
approved as an analytical testing laboratory with License No.: - KTK/37/23/2010 Dated 09-04-2013 by Drugs Controller, Karnataka, India.
Registered with Central Bureau of Narcotics Board, India for Handling Medicines with Controlled substances for Development
70 products developed or in various stages of development for regulated Markets-Europe, ANZ, USA
Strong Intellectual Property advisory team with large experience in the Pharma industry experienced in handling both domestic and international
litigations.
2. Quality Approval & Accreditation:
Audited and Approved by Health Canada
Approved Drugs & Pharmaceutical Facility by Indian FDA & Registered with USFDA
Laboratory Assessment was done by NABL (National Accreditation Board for Testing & Calibration Laboratories) – India as per ISO / IEC
17025:2005and approved successfully
Audited and Approved by WHO, Geneva; under Prequalification Medicine Program – Procedure for Assessing the Acceptability, in Principle of QC
Laboratory for use by UN agencies.
6. Concept to Commercialization - Product Email: info@stabicon.com
Confidential Document www.stabicon.com Page: 6
3. Regulatory and supply Network:
Pharmaceutical Companies from Europe, Middle East, South Africa, Canada, USA ,UK and South Asia Pacific.
7. Concept to Commercialization - Product Email: info@stabicon.com
Confidential Document www.stabicon.com Page: 7
4. Operational Portfolio:
Market Analysis
Existing Product
Portfolio GAP
Analysis
Patent
Landscape
Development
Concept &
prototype -
Active,
Technology & PM
approach
In-vitro
Model -
Safety,
Efficacy &
Delivery
Clinical
Studies
Manufacturing
process
improvement
Dossier filing Supply
Concept - Product Development – In vitro - Validation - Dossier & Supply for Nutraceutical, Herbal, OTC
8. Concept to Commercialization - Product Email: info@stabicon.com
Confidential Document www.stabicon.com Page: 8
● Formulation Development for Solid oral, Liquid and Topical & transdermal Dosage Form
● Working with NCE, NDA, ANDA and differentiating Filing
● Expertise in ODT and Resin based formulation
● Dosage conversion from one form to other
● By pass first phase of metabolism & multi delivery system
● Bioavailability Enhancements for poorly water soluble molecules
● Preservative free
● Dosage conversion and sensory development
● Targeted delivery site in Extended release suspensions or solid oral for suspensions
● Abuse Deterrent Formulations
● Mouth Melting crystals
● Multi-unit particulate Systems (MUPS) technology
● Taste masking technologies
● Combination of Immediate and sustained release
● Up gradation of conventional Product formula
● Stability Programs
● Upgrading Analytical Development & Validation
● Bio-waiver Studies (Comparative Dissolution Profiles)
● In-vitro Studies /Binding Studies
● Dossier filing for new & variation
9. Concept to Commercialization - Product Email: info@stabicon.com
Confidential Document www.stabicon.com Page: 9
DEVELOPMENT STRATEGY
5. Development Strategy
10. Concept to Commercialization - Product Email: info@stabicon.com
Confidential Document www.stabicon.com Page: 10
Development Strategy
Needs of
Organization
Challenges Address Approach Outcome
Consumer -
Feedback
1. Crowd -
Standout
Consumer
Confusion - Too
many options
Effective Unique Delivery,
Sensory, Efficacy & Safe product
Immediate Release to Modified
Release, Dosage conversion,
Combination, Packing Sensory
Development
Created Market
Space and Value
Consumer preference
increased due to
reduction in
inconvenience of
using
Regulatory
Barrier
Alternative of Protective &
Current Regulatory route
Nutraceutical to Pharmaceutical, Rx to
OTC, Improving Technology on Dosage
,Strength & Reducing Side effect
Barrier created and
delaying
competition in
market place. Users
increased
Increased Consumer
reach including
medical professional
too
Diversity of
Consumer Habit
Acceptability Across Generation
Dosage type changed to make user
friendly across generations ,Sensory
acceptance
Consumer
Preference
increased within
various level of
family
Consumer self-
interest to use
increased.
11. Concept to Commercialization - Product Email: info@stabicon.com
Confidential Document www.stabicon.com Page: 11
Development Strategy
Needs of
Organization
Challenges Address Approach Outcome
Consumer -
Feedback
Crowd -
Standout
Low Cost User Friendly
Improving Manufacturing Process,
Sourcing Alternative to reduce
commercial ,Packing enhancement
making product stabile thereby
reducing expiry expense
Improved
Production
,Expense reduced
and user population
increased due to
affordability
Value for Money in
Consumer mindset on
Brand
Awareness of
Products' Pros &
Cons
Manufacturing & Sourcing with
current Technology Dynamics
Clinically proven with consumer self-
test approach marketing program
Repeat sales
business increased
and confidence on
product increased
in consumer to use
Consumer confidence
No
Standardization -
Geography wise
Simple Consumer Validation
program
Technology Route - Nano ,Preservative
,IR , MR, Control Release, Niche Dosage
Delivery
Prompt product
business with
reduce limited
media cost
Client relief enhanced
Lack of
Integration Skill
Forum to take operation message
of all level and evaluate for
improvement. Cross functional
expertise domain head
Value addition in product synergy
effected area or beneficial area by
combination approach - changing habit
Product enhanced
360 degree
Continuous
improvement to
continue same brand ,
then shifting
12. Concept to Commercialization - Product Email: info@stabicon.com
Confidential Document www.stabicon.com Page: 12
Development Strategy
Needs of
Organization
Challenges Address Approach Outcome
Consumer -
Feedback
Crowd -
Standout
Lack of
Transparency
Micro entrepreneurs - Expertise
partnering
Fast route to Market by Product design
and regulatory approval
Focus ,Ownership
and fast to market
Client product
experience related
issue addressed
Comprised
Product - Impact
Health
Market Report on Product and
process complaint around
category product
Re - engineer the process to eliminate
market & environmental compliant
around category
Safe Product Increased Reliability
2. Brand
Addition
Brand Stagnation
Improving Consumer Extended
Application or Benefit
Pain Management : Uncomforting +
Inflammation + Muscle Pain + Knee
Joint product
Very rapidly improved consumer bases and
product ROI
Brand Dilution
Updating product with Current
trend of technology
Multivitamin Tablet for children to
Multivitamin Stable liquid In UK
Preference moved to new product from all
other brands and downsized tablet to non-
profitable category
13. Concept to Commercialization - Product Email: info@stabicon.com
Confidential Document www.stabicon.com Page: 13
Development Strategy
Needs of
Organization
Challenges Address Approach Outcome
Consumer -
Feedback
Brand Addition
Changing
Consumer Habits
Consumer Generation Preference
- Segment wise expansion
Dosage development for Elderly and
Children into Liquid dosage form with
increased palpability, Dosage
reduction
Untapped market potential tapped
Economic &
Environment
Impact
Sourcing: Review Material
specification vs current policy
and alternative improved
environmental friendly
Codeine Alternative development with
similar effect but out of narcotic
window
Continue loyalty to the brand
Consumer
Application with
other products or
Non Brand
Products
White Paper - Improve
Regulatory Aspect
Cough Cold and Fever target approach & multi angle approach combination
Consumer
Transition
Dosage - Re - engineering,
Enhance consumer experience
program on new product, packing
& Design
Introduction of Small Pack so that consumer can try. Less side effects and cell
regeneration capability , additional benefit than existing on crisis management
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Development Strategy
Needs of
Organization
Challenges Address Approach Outcome
Consumer -
Feedback
Proof of Concept
on Model- Idea
Test or Proof of concept Model
for evaluation prior to Market
test
All Body delivery model built for evaluation efficient dosage form in various platform
technology drug
Collaboration -
Multi Integration
Multiple expertise team - with
single window focus
Multiple Dosage development with few combination of actives in platform technology
to see effect in various disorders/ disease
Monopoly -
Mirroring
Patent
Non Infringing Patent
Landscaping Route
Para 665 for one client -osteoporosis
non patent infringe using technology
giving similar AUC and Cmax
Client was able to
file and get
approval
NA
Supply Chain
Alternative Equivalent /Superior
for Product Performance
Repurposed Drug for Eye aliment infection, GI acting
drug, non-absorbed drug alternative set up API
production site in partnering
Yet to reach the market
Consumer Choice
Robust Partnering Approach -
Skill Expertise Integration
Partnered with University Professor ,Doctor
,Toxicologist and Regulatory to build an alternative to
improve the wellbeing by adjuvant technology in
metabolic syndrome
Yet to reach the market
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Development Strategy
Needs of
Organization
Challenges Address Approach Outcome
Consumer -
Feedback
Monopoly -
Mirroring
Regulatory Consumer Surprise
Platform Technology with Consumer devices to test
themselves
Yet to reach the market
Regional Leader Localized Business Partnering
Technical, Patent Regulatory, Manufacturing support
partner In major countries
NA
R & D Strong
Experience &
Expertise in
House
Diversified & Integrated
Lactose Intolerance ,Plant Extract high end purification
to API conversion
NA
R & D centre
In-organic
Growth
Cross-functional
Industry Process
Workshop
Develop platform technology to support Pharma, Nutraceutical, Food & Beverages
segment
Relook at Policy
v/s Consumer
Needs
Set up Panel Member team to
participate in forum & Advisory
Board to advice
Being an active member in Research Panels of Govt. and Association Bodies
Innovation &
Concept
Incubation to
support creative
mind & team
Mentoring, Direction, Funding
,Test & Integration
In progress
Same process /
Product-
Diversification of
Application
Vendor Partnering for increasing
application to address future
needs
Process to enhance the aroma , dispersion, Stabilization ,Solubility and Permeability in
various dosage forms
Unmet Needs
Partnering with Academic
,Regional Control
COVID -19 Prevention Program with Govt. of Karnataka, Developing rare disease
dosage form to evaluate delivery
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6. Business Model:
Collaboration Model
Open Source Business Model
1
2
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7. Formulation & Development Division
Formulation Development
Formulation Development
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7a. Capacity & Capability
a. Stabicon Formulation Development Capacity & Capability
Industry Segment: Pharmaceutical ,Bio - molecule & Health Supplement
Drug Delivery
System
Type Dosage form
Number of Product
Development
Capacity/Per Year
Number of Product
Development Capacity
infrastructure available for
Expansion
Oral Delivery
through Digestive
tract(enteral)
Solids
Pill 20 10
Tablet 20 10
Capsule 20 10
Lozenges & Pastille 22 11
Buccal& sub lingual Tablets 15 8
Osmotic delivery system (OROS) 8 4
Granules, Powder 15 8
Modified Release 12 6
Effervescent Granules or tablet 18 9
Chewable Tablets 18 9
Liquids
Drops 18 9
Elixir 18 9
Gargles& Mouth Wash 22 11
Emulsion 12 6
Extended-release syrup 8 4
Suspension 12 6
Hydrogel 18 9
Molecular encapsulation 5 3
Lint uses 18 9
Solution 18 9
Syrup 22 11
Spray 22 11
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Stabicon Formulation Development Capacity & Capability
Industry Segment: Pharmaceutical ,Bio - molecule & Health Supplement
Drug Delivery System Type Dosage form
Number of Product
Development
Capacity/Per Year
Number of Product
Development Capcity
infrastructure avaliable for
Expansion
Ophthalmic /Otologic / Nasal
Spray 12 6
Drops 15 8
Ointment 18 9
Hydrogel 18 9
Nano sphere suspension 5 3
Insufflation 4 2
Mucoadhesive micro disc
(microsphere tablet)
3 2
Urogenital Solid/Liquid
Ointment 18 9
Pessary (vaginal suppository) 12 6
Extra-amniotic infusion 15 8
Tablets 18 9
Intravesical infusion 15 8
Rectal (enteral) Solid/Liquid
Ointment 18 9
Suppository 12 6
Enema 12 6
Solution 18 9
Hydrogel 15 8
Murphy drip 8 4
Nutrient enema 12 6
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Stabicon Formulation Development Capacity & Capability
Industry Segment: Pharmaceutical ,Bio - molecule & Health Supplement
Drug Delivery
System
Type Dosage form
Number of Product
Development Capacity/Per
Year
Number of Product
Development Capacity
infrastructure available for
Expansion
Dermal Solid/Liquid
Ointment 18 9
Topical gel 15 8
Liniment 15 8
Paste 15 8
Film 8 4
DMSO drug solution 8 4
Hydrogel 8 4
Liposomes 5 3
Transfer some vesicles 5 3
Cream 18 9
Lotion 15 8
Medicated shampoo 15 8
Dusting Powder 12 6
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7b. Stabicon – Client Scope in Product Development Activity:
Product
Develop
Validati
on
Dossier
Commercial
Manufactur
ing
Marketing
Customer Proposed Scope
Stabicon Life Sciences Proposed Scope
New
Enquiry
To
produce
Submit
To
Produce
To
Organize
it
Complete
Activity
Technology
Transfer &
F1 F2
Dossier
Preparation
Annual
Stability
Post
Market
sample
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7c. Formulation Development Business Process:
Product design, research and development (PDR&D) is a cycle of continuous improvement over time that includes four stages: product idea
generation; product selection; product development; and launch. Substantial investment in PDR&D can be made with the aim of extending the
market life of products through product extension strategies, which drive long-term profitability and future iterations of product development.
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7d. Product Development Approach will be based on QBD typically follow this format:
1. Define (Quality) Target Product Profile
2. Define (Critical) Quality Attributes
3. Outline Process Maps
4. Identify (Critical) Process Parameters and (Critical) Material Attributes
5. Risk Assessments
6. Design Space Studies (Design of Experiments)
7. Update Risk Assessment
8. Control Strategy
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7e. Formulation Development Work Flow:
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7f. Product Development Risk Analysis:
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7g. Generic Formulation Development Timelines:
S. No Development Stage Timeline (months)
1 Innovator sample procurement, Pre-formulation and Bench scale studies 1-4
2 Lab scale and process development studies 2-4
3 Process optimization and Pharmaceutical-Equivalence 1-2
4 Accelerated Stability Studies 6 -8
5 Technology Transfer to Manufacturing Site for Validation Batches 0.5-1
Total Development Time
10-24months
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7h. Development Activity Milestone:
S. No. Activity Outcome Reports
1. Licenses Copy of certificates issued by necessary authorities.
2. API and Excipient sourcing & qualification Vendor finalization & generation of necessary Certificate of Analysis
3. Reference product analysis Evaluation of reference product quality attributes and generation of Certificate of Analysis
4. Pre-formulation & Compatibility study
Screening out compatible excipients and generation of report with necessary data /
chromatograms
5. Formulation Development Trials to finalize batch composition
6. Method development Method development documents.
7. Stability Study for lab batches Stability study report
8. Process optimization / Scale up Process optimization / Scale up report
10. Analytical Method validation Analytical Method validation Report
11. Tech Transfer Documents Necessary documents to transfer the product.
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7i. Formulation Development /Up-gradation of existing Formulation Development Cycle
Project Schedule Template:
S. No. Activity Outcome Reports Completion Proposed Date Actual- Date Remarks
1 Licenses
Copy of certificates issued by
necessary authorities.
2
API and
Excipient
sourcing &
qualification
Vendor finalization & generation
of necessary Certificate of
Analysis
3
Reference
product analysis
Evaluation of reference product
quality attributes and generation
of Certificate of Analysis
4
Pre-formulation
& Compatibility
study
Screening out compatible
excipients and generation of
report with necessary data /
chromatograms
5
Formulation
Development
Trials to finalize batch
composition
6
Method
development
Method development documents.
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7
Stability Study
for lab batches
Stability study report
8
Process
optimization /
Scale up
Process optimization / Scale up
report
9
Multimedia
Dissolution
Comparative Dissolution Profile
Report for multiple strengths
10
Analytical
Method
validation
Analytical Method validation
Report
11
Tech Transfer
Documents
Necessary documents to transfer
the product.
12
Tech Transfer
& Process
validation
Transfer of technology with
necessary process validation &
Report
13
Stability for the
Validation
batches
Stability study report
14
Bioequivalence
Study
Bioequivalence Report
Total product development time schedule = 18 to 24 Months
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8. Technology Checklist:
Sr. No PARTICULARS
1 Intellectual/Patent Status of API used
2 Intellectual/Patent Status of Finished Product developed
3 Formulation Approach Infringing Non-Infringing
4 Product Developed for which Market
5 Product Commercially launched
6 Business Module (dossier will be exclusive)
7 API details Salt/Polymorph
8 Availability of Standard of Polymorph used
9 DMF availability NON ICH EUDMF Grade USDMF Grade
10 API owned by the Finished Product Manufacturer
11 Commitment of Letter of Access (LOA) to Closed Part of DMF YES NO
12 If API owned by other than finished product manufacturer
commitment of supply from the API vendor
13 GMP Certificates (API Manufacturer) YES NO
14 API Country of Origin
15 Reference Sample Strength and Country of Origin
16 List of Excipients
17 Excipients Grade Pharma/Food
18 Excipients comply with Inactive Ingredient Guide
(IIG ) Limits
19 Excipients Certification TSE/BSE/Halal/Gluten free
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20 Pigment Restriction, if any
21 Dose Proportionality/Look alike formula in case of Multiple
Strength Product
22 Manufacturing Process (Any special requirement) with respect to
area and equipment
23 Any organic solvent used during manufacturing process
24 Manufacturing Batch Scale Range
25 Process Optimization and Risk Assessment Performed
26 Holding time stability data established for granules/core and coated
tablets
27 Analytical activities out sourced or In house
28 Any special reagent column material required
29 Analytical Method Development YES NO
30 Analytical Method Validation YES NO
31 Excipients Compatibility Studies Performed YES NO
32 Force Degradation Studies Performed YES NO
33 Impurities profile Pharmacopoeia/ICH
34 Genotoxic impurities, if any
35 Any impurities identified/qualified
36 Comparative Multimedia Dissolution of Test Vs Reference
Performed
YES NO
37 Certificate of residual solvent in API excipient and finished
products
38 Supporting document for polymorphic conversion during stability
39 Pilot BE Study Performed YES NO
40 Primary Packaging Details
1. Pack Size: ________________
2. Details of Packs (e.g. HDPE, Blister etc): ______________
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41 Stability study as per regulatory requirements
42 In-Use stability data, if applicable
43 Photo Stability study, if require
44 Freeze thaw study, if required
45 Leaching study, if required
46 Sedimentation and redispersability study if applicable
47 Panel study for taste evaluation if applicable
48 Microbial study
49 Particulate matter in case of sterile product
50 Preservative efficacy if applicable
51 Method of sterilization for sterile product
52 Sterility testing wherever applicable
53 Oozing study, if applicable
54 Stability Batch Size and Type
(1/10th or 100,000 Production Batch as per regulatory Guidelines) Batch Size_________________
55 Special Precaution for Storage
56 Shelf Life
57 Pivotal BE Study Performed YES NO
58 Type and Study Design
59 Pivotal BE Study RLD used
60 Complete Dossier in CTD Format YES NO
61
Commitment for personal presence, if required during technology
transfer activities
62
Commitment of support during regulatory submission and queries
responses
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8a. Generic Product pipeline and its status
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8b. Innovation Product pipeline and its status
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9. Quality Management System (QMS):
◦ Rich experience of regulatory documentation submissions for regulated markets
◦ Works closely with execution teams throughout product life cycle from the very beginning- licenses, review of development, vendor documents,
until dossier development and submission.
◦ Robust Regulatory Strategy- All scientific disciplines / aspects and constantly changing regulatory requirements considered.
◦ Rich Expertise in Submissions in eCTD, ACTD, ANDA, country specific formats,
◦ Well experienced in all different types of submission procedures -DCP, MRP as well as FDA.
◦ Comprehensive documentation, and meticulous, QC checked, archiving of documents etc.
We intend to use software in compliance management with proven success in deploying regulatory compliance solutions to global pharmaceutical,
biotechnology and medical device companies. MS will provide a closed-loop compliance platform that enables you to integrate the common elements of
compliance across both our organizations, including content, processes, people and systems. MS solutions for document and quality management, submission
management and regulatory approval enable us to accelerate time to market, decrease compliance risks, improve operational efficiencies, reduce quality issue
and will give overall control over our site.
Pharmaceutical Quality Management Software:
quality management software (QMS) will enable us to:
Create and manage SOPs throughout the lifecycle: create, review, edit, approve, distribute and retire
Ensure that all users have access to the relevant documentation
Comply with audit trails and 21 CFR Part 11 electronic signatures
Address OOS, OOT deviations and related corrective and preventive actions (CAPA) in real-time, including automatic integration with the relevant
document
Manage the control of change across multiple sites and projects
Monitor trends and exceptions with dashboards and reports
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Packaged software solutions for QMS and R&D:
A number of packaged solutions that are pre-defined, pre-tested and ready to deploy, including:
CAPA Process Package
Deviation Process Package
Change Control Process Package
Complaints Process Package
Audit Process Package
Quality Documents Package
R&D Submission Documents Package
Each package can be designed to address a specific business function and includes all required software, implementation services, training and
documentation. These packages can be combined and built upon over time to address growing compliance requirements. The QMS facilitates integration
with a wide variety of third-party systems, including ERP, LIMS, LMS, and so on.
Accuracy of Data quality:
We have internal independent quality assurance team who conduct audit every six months and in process check of project on a regular basis. Audit Trail are
reviewed are reviewed by quality assurance to ensure data integrity. Web access of all application software can be provided to ensure transparency in
operations provided volume of project is large and long-term.
Statistical Analysis on data integrity can be submitted every six months.
Regulatory Submission: Our team has completed stability studies for our client from South Africa and Europe for their dossiers submission and accepted
Lab Technology Expertise Available for:
1) In-vitro Studies as per regulatory: Nonsystematic circulation therapeutic molecule formulation
2) ADME: In-vitro Profiling
3) Biopharma: Analytical and Characterization
4) Impurity Profiling
5) Medical Devices Stability Program
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10. CTD Dossier
R&D software for regulatory submissions: We use QMS and Dossier Module software solutions for R&D will enable us to
manage the creation, review, and approval of all content required for regulatory submissions. They allow the use of eCTD authoring templates for submission
readiness and enable us to collaborate on content throughout the product development lifecycle, batch import or scan paper documents, reuse submissions
across global regulatory agencies, and monitor progress with dashboards and reports.
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Feature of Dossier Software where it is tested and ready for installation
It will automate the entire regulatory publishing process
It can transform up to 155 file formats to PDF while maintaining 100%-page fidelity
It can integrate with multiple repositories simultaneously
It can be implemented on one server, or multiple servers depending on need and scalability requirements
It will support multiple simultaneous output formats (e.g., PDF, paper, CD-ROM, Web, etc.)
It has successfully published over 5,000 submissions, including some of the largest submissions in the world
The fact is, submission publishing process is absolutely mission critical. Software will support to deliver solutions that help us in:
Simplify and standardize the entire regulatory publishing process &Dramatically improve efficiency
Reduce time to market Repurpose information assets time and again
Dossier Various software Module Support us in our Partnership for
Drug Development Portfolio Management
Integrated project Schedule & Resource management with Evidence Creation
Structured electronic Drug Development Record
Automated lab development Archive& Design Dossier Management
Integrated Clinical Supply Development & Management
CMO collaboration & Material Chain of custody management
Technology Transfer & Collaboration
Secure collaboration(in text) with evidence archive & Knowledge reuse
Integrated Quality & Risk Management
Compliance & quality from Development through commercialization enable QBD
Comprehensive Packing & Collateral Management
Packing Labelling & Collateral content Synchronized with Registration
Global Product Registration
Product Registration Strategy, Submittal Creation, eCTD Management & Dossier
Maintenance
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11. Alliance Model Case Study Example
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Thank You for your Valuable time.