Analytical Development Services
A GMP product is a prerequisite for any further product development such as a human study. If product quality cannot be demonstrated to be well characterized and consistently maintained then the authorities are likely to immediately reject a submission for claims or product approval. End of story. A critical element to GMP is active ingredient assay which is challenging in natural products and often this portion of the dossier can be easily questioned. Vedic Lifesciences organizes the analytical method development and standardization of dietary supplements and other natural health products to exacting global standards and to the needs of the client or the market.
We have access to the finest equipment, reference marker compounds, reagents, kits and test protocols in the industry. Our partner labs maintain state of the art instrumentation such as HPTLC, GC, HPLC, LC-MS, ICP-MS, etc.We can standardize your food ingredient or finished product for disallowed residual solvents using latest analytical tools like GC-HS, GC-MS to detect traces of solvents upto ppb levels & thus complying limits as per USP & ICH Q3C (R4) guidelines. Heavy metals (arsenic, cadmium, lead and mercury) can be tested individually by using latest technologies like ICP-OES & ICP-MS.
Formulation Development Services
Ensuring integrity of the product on the retail shelf (stability), the complete delivery of the functional actives to the physiological sites of action (bioavailability) and the aesthetics and convenience of the final product to today’s demanding consumer are all subjects of immense research in our industry and offer huge opportunities for product innovation and differentiation. Due to the grand-fathering rules in most regions and drying of new molecular pipelines, novel formulations or delivery systems such as sprays, patches, sublingual strips, etc. are sometimes easy pathways to meeting unmet needs or even creating a niche brand offering.
Vedic Lifesciences has partnered with labs and Contract manufacturers to create unique delivery systems in foods and supplements or carry out routine trouble shooting in existing products. Our novel formulations have been part of dossiers for new product approvals submitted to FDA. Call us to have a discussion on what is possible for your specific product and market type.
Cosmeceutical Research Services
|Cleaning /ConditioningGrowth stimulation
Styling / Coloring
|Oral hygieneEye care
Weight loss and management
Vedic Lifesciences has a specialized team of dermatologists and site staff to conduct and monitor safety and efficacy studies for cosmetics,cosmeceutical, dermatological and personal care products.
Services provided by Vedic especially for these products:
- Invitro screening of herbal extracts for cosmeceutical applications
- Phototoxicity studies invitro SPF testing: Estimation of protection from UVB (short wave UV light) and UVA (long wavelength UV light)
- Patch testing as per ASTM or BIS standards
- Assistance in product development stage
- Human volunteer clinical studies for the assessment of efficacy and safety
Turn-key Solutions for Indian Market Entry (TIME)
Vedic Lifesciences supports companies who are keen on launching their products in India at 3 stages:
- Indian Regulatory Services: Submission and Registration of approvals for Marketing of products in India
- Indian Manufacturing Services: Raw material supplier identification and development, Laboratory scale batches, Tech transfer support to manufacturing scale.
- Indian Sales and Distribution Channels: Setting up with national level distributors of nutraceutical/food supplements, Advertising/marketing support, New geography and market segment identification
Bioavailability/ Bioequivalence (BA/BE) services
Following types of studies are managed by Vedic
- Relative bioavailability of established and experimental formulations
- Single and multiple-dose (steady state) kinetic studies
- Fasting / food-effect kinetic studies
- Drug interaction studies
- Studies comparing immediate and modified release formulations
- Pharmacodynamic studies
- Studies comparing various routes of administration
- Studies in special population (pediatric, geriatric, post menopausal women)
- Bioanalytical / Analytical Method Development & Validation
- Selection of centre based on sponsor/study/regulatory requirement
- Complete Project Management
- Site Audits and Site Monitoring
- Review of essential documents including the protocol, ICF,CRFs, etc
- Review of method development and validation reports, statistical analysis reports, study reports
- End to end monitoring of the study activities at the centre (volunteers check in activities, ICF presentation, screening of volunteers, IP dispensing and administration, AE/SAEs, blood collection and sample processing, storage, sample analysis, etc)
- Audits of vendors
- Prompt, periodic and transparent reporting to sponsor
505(b)(2) support services
- A 505(b)(2) application is one for which one or more of the investigations relied upon by the applicant for approval “were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted” (21 U.S.C.355(b)(2))
- 505(b)(2) is one of the routes the US FDA has approved for companies to launch their products quickly into the markets.
- Vedic supports the product development needs for companies filing through this route right from New Formulation development, Analytical Method Development, Validation, Stability testing and human volunteer studies to dossier preparation, submissions and regulatory meetings.