Presentation on theme: "AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH Claim Substantiation for Cosmeceuticals through Clinical Testing."— Presentation 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. Services Services Regulatory Dossier Preparation & Consulting Preclinical Formulation and Standardization Toxicology In vitro & In vivo Animal studies Clinical Human Bioavailability Studies Human Clinical Studies Medical Writing 3
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 SKINHAIROTHERS 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 InstrumentMeasuresEvaluates efficacy of Visiometer®Wrinkle DepthAnti Ageing Products Cutometer®Skin ElasticityAnti Ageing Products Tewameter®Skin SoftnessMoisturizers Chromameter®Skin color according to pigmentationFairness creams, tanning products Mexameter®Skin melanin content / erythemaFairness creams, tanning products, anti-marks creams Sebumeter®Skin OilinessAnti-acne products Corneometer®Skin MoistureMoisturizers Visioscan®Skin Surface TextureMoisturizers Skin Ph®pH-level on the skin surfaceSoaps, 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 LIGHTENING Visiometer® 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 13
Skin Softness Tewameter ® Manufacturer: Courage + Khazaka electronic GmbH Measures trans epidermal water loss Evaluates efficiency of the skin water barrier 14
Skin Fairness Chromameter ® Manufacturer: Konica Minolta Measures the skin color according to L* Lightness a* Redness b* yellowness 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 oiliness Sebumeter® 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 dryness Visioscan® Manufacturer: Courage + Khazaka electronic GmbH Measures the level of dryness of the skin Measures desquamation on skin and scalp Evaluates sebum production 19
Skin pH Skin-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 people 21 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.
Vedic. Key people 22 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. 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@example.com@vediclifesciences.com, www.vediclifesciences.comwww.vediclifesciences.com 24