claim substantiation for cosmeceuticals / personal care products through human clinical testing
DESCRIPTION
Vedic Lifesciences has extensive experience in designing, conducting and reporting of clinical studies for cosmetics, cosmeceuticals, personal care products and other dermatological products.TRANSCRIPT
AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH
Claim Substantiation for
Cosmeceuticals through Clinical Testing
Vedic. Introduction
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
2
Vedic. Services3
Vedic. Benefits
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
4
Vedic. Capabilities
5
SKIN HAIR OTHERS
Lightening/Fairness
Anti-ageing
Acne/oil control
Blemishes/Marks
Softness/Elasticity
Body odour
Excessive sweating
Cleaning
/Conditioning
Growth stimulation
Growth retardation
Dandruff Control
Styling / Colouring
Repair
Oral Hygiene
Eye care
Weight Loss and
Management
5
Vedic. Site Capabilities
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
6
Vedic. Invitro Tests
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
7
Vedic. Safety Studies – Standards & Methods
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
8
Vedic. Clinical Studies Expertise
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
9
Vedic. Investigators
Rich experience in managing Dermatology and Venereology patients
Dynamic, energetic and result oriented professionals Ability to deliver quality data within specified timelines
10
11
Vedic. Instrumental Capabilities
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
Studies the skin surface directly with Special UV-A light
Shows the skin structure and level of dryness
Evaluates desquamation and sebum production
SKIN LIGHTENINGVisiometer®Manufacturer: Courage + Khazaka electronic GmbH
12
Elasticity / Anti – ageing Cutometer ®Manufacturer: Courage + Khazaka electronic GmbH
Measures precise skin elasticity
The chart shows elasticity as a function of age
00.10.20.30.40.50.60.70.80.91
0 10 20 30 40 50 60 70 80
Cu
tom
eter
Rea
din
g
Age
Elasticity
13
13
Skin SoftnessTewameter ®Manufacturer: Courage + Khazaka electronic GmbH
Measures trans epidermal water loss
Evaluates efficiency of the skin water barrier
0.0
1.0
2.0
3.0
4.0
5.0
6.0
0 4 8 12 16 20 24
TE
WL
(g
/m2
/h)
No. of hrs
Moisture-Locking Ability
Lotion Cream Control
14
14
Skin FairnessChromameter ®Manufacturer: Konica Minolta
Measures the skin color according toL* Lightness
a* Redness
b* yellowness
15
15
Skin Fairness Mexameter ® Manufacturer: Courage + Khazaka electronic GmbH
16
Measure the two components, mainly responsible for the colour of the skin:
Melanin and Hemoglobin (erythema)
16
Skin oilinessSebumeter®Manufacturer: Courage + Khazaka electronic GmbH
17
Allows determination of even slightest changes in the skin surface sebum content
Measures oiliness in acne prone skin
17
Skin softnessCorneometer ®Manufacturer: Courage + Khazaka electronic GmbH
Measures skin moisture levels
18
18
Skin drynessVisioscan®Manufacturer: Courage + Khazaka electronic GmbH
Measures the level of dryness of the skin
Measures desquamation on skin and scalp
Evaluates sebum production
19
19
Skin pHSkin-pH-Meter® Manufacturer: Courage + Khazaka electronic GmbH
20
Evaluates the quality of the Hydrolipidic film on the skin
especially in developing soaps, cleanser or detergents
20
Vedic. Key people21
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.
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.
• 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.
Vedic. Key people22
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.
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.
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
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.
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.
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.
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.
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
[email protected], www.vediclifesciences.com
24