Vedic Lifesciences has extensive experience in designing, conducting and reporting of clinical studies for cosmetics, cosmeceuticals, personal care products and other dermatological products.
2. Vedic. Introduction
2
A decade of experience as full and functional service CRO
Widest range of services for the Nutraceuticals, Dietary Supplements,
Botanical Drug Products, Medical Foods, Natural Health Products,
Cosmetics & Personal Care Products
Clinical trials for label claim substantiation
Compliant data to meet regulatory requirements
Efficient study design for testing cosmetic products
Cosmetic efficacy studies
Quality check of developed product
Delivery of safe and effective products to the customers.
ISO 9001:2008 certified
Headquarters in Mumbai, india with office in California, USA
4. Vedic. Benefits
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Experienced team of medical experts with experience in studies for Acne,
Melasma, Weight Loss, Hair removals, etc
Claim Substantiations possible - “Clinically Proven” tags at affordable
costs
Protocols made in accordance with ICH-GCP
Unmatched Quality, Effective Costs and Reduced Timelines
End to end service provider for all your products
Quality Research for better market acceptance
5. Vedic. Capabilities
5
SKIN HAIR OTHERS
Lightening/Fairness Cleaning Oral Hygiene
Anti-ageing /Conditioning Eye care
Acne/oil control
Growth stimulation Weight Loss and
Blemishes/Marks
Growth retardation Management
Softness/Elasticity
Dandruff Control
Body odour
Styling / Colouring
Excessive sweating
Repair
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6. Vedic. Site Capabilities
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Access to Right Set of Volunteers
Comprehensive and Independent Facility
Specialized in Cosmetics, Cosmeceutical and Dermatological Safety and
Efficacy studies
Offer services to National and International sponsors for Safety as well as
Efficacy Testing
Fulfill client’s expectations with Reliable, Consistent and Efficient
performance
7. Vedic. Invitro Tests
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Invitro screening of herbal extracts for cosmeceutical applications
Skin irritation
Phototoxicity
E.g: Invitro SPF testing: Estimation of protection from UVB (short wave
UV light) and UVA (long wavelength UV light)
Instrument Used: Optometrics LLC, SPF- 290S
Assist in product development stage
8. Vedic. Safety Studies – Standards & Methods
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Standards followed:
ASTM
BIS
Primary Irritation Patch Test:
To ascertain the safety in terms of irritation potential of the cosmetic
products against a positive control on the healthy human subjects
Repeat Insult Patch Test:
The objective of this test is to determine the irritation and/or sensitization
potential of the test material(s) after repeated application under occlusive,
semi- occlusive or open patches to the skin of human subjects
The above are based on Client requests and preferences
9. Vedic. Clinical Studies Expertise
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Clinical studies compliant to ICH –GCP
Experienced medical writing team
Dedicated project management team
ICH-GCP trained and qualified clinical research monitors
Independent ethics committee approvals
Evaluations for clinical studies based on:
Expert dermatologist assessment
Instrument assessment
Self assessment carried out by the volunteers
Comprehensive data management and statistical analysis
Final report writing
10. Vedic. Investigators
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Rich experience in managing Dermatology and Venereology
patients
Dynamic, energetic and result oriented professionals
Ability to deliver quality data within specified timelines
11. Vedic. Instrumental Capabilities
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Instrument Measures Evaluates efficacy of
Visiometer® Wrinkle Depth Anti Ageing Products
Cutometer® Skin Elasticity Anti Ageing Products
Tewameter® Skin Softness Moisturizers
Chromameter® Skin color according to pigmentation Fairness creams, tanning products
Mexameter® Skin melanin content / erythema Fairness creams, tanning products, anti-
marks creams
Sebumeter® Skin Oiliness Anti-acne products
Corneometer® Skin Moisture Moisturizers
Visioscan® Skin Surface Texture Moisturizers
Skin Ph® pH-level on the skin surface Soaps, Face Wash
12. SKIN LIGHTENING
Visiometer®
Manufacturer: Courage + Khazaka electronic GmbH
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Studies the skin surface directly with Special UV-A light
Shows the skin structure and level of dryness
Evaluates desquamation and sebum production
13. Elasticity / Anti – ageing
Cutometer ®
Manufacturer: Courage + Khazaka electronic GmbH
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Measures precise skin elasticity
Elasticity
1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
m
R
C
g
n
d
o
u
a
e
r
t
i
0.1
0
0 10 20 30 40 50 60 70 80
Age
The chart shows elasticity as a function of age
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14. Skin Softness
Tewameter ®
Manufacturer: Courage + Khazaka electronic GmbH
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Measures trans epidermal water loss
Evaluates efficiency of the skin water barrier
Moisture-Locking Ability
6.0
5.0
4.0
3.0
2.0
W
m
E
h
g
L
T
2
)
(
/
1.0
0.0
0 4 8 12 16 20 24
No. of hrs
Lotion Cream Control
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15. Skin Fairness
Chromameter ®
Manufacturer: Konica Minolta
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Measures the skin color according to
L* Lightness
a* Redness
b* yellowness
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16. Skin Fairness
Mexameter ®
Manufacturer: Courage + Khazaka electronic GmbH
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Measure the two components, mainly responsible for the
colour of the skin:
Melanin and Hemoglobin (erythema)
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17. Skin oiliness
Sebumeter®
Manufacturer: Courage + Khazaka electronic GmbH
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Allows determination of even slightest changes in the skin
surface sebum content
Measures oiliness in acne prone skin
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19. Skin dryness
Visioscan®
Manufacturer: Courage + Khazaka electronic GmbH
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Measures the level of dryness of the skin
Measures desquamation on skin and scalp
Evaluates sebum production
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20. Skin pH
Skin-pH-Meter®
Manufacturer: Courage + Khazaka electronic GmbH
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Evaluates the quality of the Hydrolipidic film on the skin
especially in developing soaps, cleanser or detergents
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21. Vedic. Key people
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Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences. He has been
involved in product development and international business since 1994. He is thorough with
regulatory affairs, research and marketing for nutraceutical and phyto-pharmaceutical actives
and formulations for the EU and US markets. Trained in Pharmacy and Microbial
Engineering from University of Minnesota, Jayesh was responsible for the Biocatalyst and
Natural Products technical support and national sales at Boehringer Mannheim India in the
early ‘90s.
• Dr. Navneet Sonawane is heading the Clinical Research Department. She has 12 years
of experience in the field of Medical Science & Clinical Research, which include areas
such as Medical Writing, Regulatory Affairs, Project Management & QA. She has
successfully headed Global Clinical Studies across various therapeutic segments. During
her tenure at Vedic, she has developed a strong network of GCP trained clinical
investigators around India and has been appreciated by Sponsors around globe. She
places a high premium for meeting time line while ensuring delivering of quality.
22. Vedic. Key people
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Kunal Bhatt has 8 years of experience within the pharmaceutical industry, having led
several Global Phase I - IV drug studies in various capacities and diverse therapeutic areas
like Neurology, Psychiatry (Adult and Pediatric), Oncology, Diabetes, Urology and Cardiology.
Masters in Pharmacology and Biotech from Sheffield Hallem University, UK, Kunal has worked
in areas of Global Project Management, Clinical Operations and Regulatory. As a Global
Business Development Manager his good business planning acumen and interpersonal relations
help in crafting Business & Marketing Plans.
ANIL YADAV leads VL’s QA department. After completing his graduation in
Microbiology he obtained a Master degree in Biochemistry from the Mumbai University.
He brings in over 7 years of experience in the field of Quality Assurance with actual
hands on experience in Product development, Documentation and Training.. His focus at
VL on System development and Training activities has helped in constant up-gradation of
our expertise and abilities.
23. Vedic. Key people
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Sakshi Pawar is involved in handling Feasibility and Project Management of trials at
Vedic and has over 11 years of professional experience in Clinical Research. During
this period she has actively participated in sponsor/regulatory audits, including those
conducted by USFDA, MHRA, EMEA and DCGI. . Sakshi has completed her
Diploma in Clinical Research and General Nursing and Midwifery. She has worked
for BA-BE studies.
Seema Damakale has got a total work experience of 7 years in Pharma and
Research industry. She has played various roles during her tenure, right from Sales
and Marketing to Quality Assurance and now, Project Management. With her
exuberance and dedication towards project work and her quest for meeting
timelines, she has been an excellent role model. Seema is a Science Graduate and
has completed her Post Graduate Diploma in Clinical Research and Diploma in
Business Management.
24. 24
India
203, Morya Landmark 1, Off new Link Road, Andheri West,
Mumbai 400053
Tel.: +91 22 42172300 / +91 22 42025719
USA
552, Shorebird Circle, Unit #1101, Redwood Shores, CA. 94065
Tel.: (650) 855-4832
bizdev@vediclifesciences.com, www.vediclifesciences.com
Editor's Notes
Chromameter readings are expressed as a 3-digit output L*a*b* where L* measures skin reflectance or lightness—this is a gray scale with values from 0 to 100 where 0 is black and 100 is white; a* measures the color saturation from red to green—the scale is from + 60 to -60, where positive values indicate varying intensities of red; b* measures the color saturation from yellow to blue—the scale is also from + 60 to -60, where positive values indicate varying intensities of yellow