Concept to Commercialization- Health & Wellness Product

Page: 1
Index
Page No
Think Innovative
Concept to
Commercialization –
Health & Wellness
Product

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

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

Karnataka State, India: Historical Building

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.

3. Regulatory and supply Network:
Pharmaceutical Companies from Europe, Middle East, South Africa, Canada, USA ,UK and South Asia Pacific.

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

● 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

DEVELOPMENT STRATEGY
5. Development Strategy

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.

Needs of
Organization
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

Needs of
Organization
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

Needs of
Organization
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

Needs of
Organization
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

Needs of
Organization
Consumer -
Feedback
Monopoly -
Mirroring
Regulatory Consumer Surprise
Platform Technology with Consumer devices to test
themselves
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

6. Business Model:
Collaboration Model
Open Source Business Model
1
2

7. Formulation & Development Division
Formulation Development
Formulation Development

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

Stabicon Formulation Development Capacity & Capability
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

Stabicon Formulation Development Capacity & Capability
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

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

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.

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

7e. Formulation Development Work Flow:

7f. Product Development Risk Analysis:

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

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.

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.

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

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

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): ______________

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

8a. Generic Product pipeline and its status

8b. Innovation Product pipeline and its status

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

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

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.

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

11. Alliance Model Case Study Example

Thank You for your Valuable time.

Concept to Commercialization- Health & Wellness Product

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