Total Herb Solutions USA / America Ayruvedic CRO, Botanical CRO, Ayurveda CRO, Plant Extract CRO
Herbal Research Center, Dietary Supplement Research Center, Nutraceutical Research Center
The organization is instituted with the main intension of providing research and development input for the Herbal drug industry, Ayurvedic formulators, Nutraceuticals and Functional foods organizations. Our team comprises of botanists, process technologists, analysts, and clinical pharmacologists who in turn will ensure a product of high quality and efficacy.

Identification of herbs and its application : Herbs are produced in two main ways: collection of wild-crafted plants from their natural habitats in the wild and cultivation of herbs that are grown using commercial farming techniques. Plants from cultivated sources provide better guarantees that the plant collected is the one that is desired, while in wild-crafted herbs there is a chance that the wrong herb has been picked, which could lead to serious consequences.

Herb authentication is a quality assurance process that ensures the correct plant species and plant parts are used as raw materials for herbal medicines. The proper authentication of herbal raw materials is critically important to the safety and efficacy of herbal medicines. We carry out Identification and authentication of botanicals, medicinal plans and raw herbs by taxonomy, morphology, macroscopic, microscopic, histochemical, chemical and chromatographic techniques.
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validation of herbs, Herbs manufacturer, Indian medicinal herbs, Herbal extracts,Herbal formulation,Ayurvedic Standardization
Herbal Research, validation of herbals,validation of herbs,Contract Research Lab,Herbal Standardization
Herbal formulations,contract research organization,Dietary Supplement Research Center, Dietary Supplement Animal Toxicity
Process and technology development for extraction of herbal drugs : We provide complete solution for technological development from lab level to industry scale for herbal drug extraction. We judiciously work out the parameters which include selection of solvent, time for the process and temperature at which extraction is to be carried out. The process so developed will ensure extract with high content of bio-molecule at the same time helping in saving time, energy and cost.
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Development of new formulation, application, process and technology : Development of herbal formulations is a specialized field which needs in depth knowledge of herbal raw materials, its dose, their chemical compositions, possible interaction between chemicals from other herbs, compatibility of excipients, packing material, and final application of the product. We undertake to develop the herbal drug formulation on scientific basis taking into considerations the various aspects associated with it.

Our formulation development capabilities include :

  • Feasibility study
  • Formulation composition
  • Designing of dosage form
  • Process optimization
  • Scale up

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Development of Analytical profile : Phytochemical methods have been modernized considerably over the past decades. Classical chemical methods have been progressively replaced by high performance instrumental techniques. In many cases however botanicals and herbal medicinal products resist analytical characterization due to the complex composition of plant extracts and difficulties in finding analytical targets and markers the contributes to the pharmacological and therapeutic effects.

We at THS with the help of modern phytoanalytical chromatographic methods develop complete analytical profile (Chemical fingerprinting) of herbals.

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Testing and standardisation of herbal medicines

Quality Control Services

  • Standardization and Control of Herbal Actives.
  • Testing and Control of Impurities: Foreign matter, adulterants, Physico-Chemical analysis, Heavy Metals, Pesticides, Residual Solvents, Alfatoxins, Microbial limits, etc.
  • Isolation and purification of marker compounds.
  • Ingredient Standardization and Testing.
  • Formulation Standardization as per EMEA guidelines.
  • Battery of tests applied ranging from simple chemical assays to Chromatographic Analysis.
  • Method Development for Stability Studies and Pharmacokinetic Studies.
  • Trouble-shooting for Polyherbal Formulations.
  • Impurity profiling and characterization.
  • Accelerated Stability studies according to ICH and other regulatory requirements.
  • Preparation of Chemistry, Manufacturing and Controls (CMC) Dossier.
  • Bioanalytical Method Development.
  • Quantitative analysis of ingredients in the formulation without using marker compounds.
  • Nutritional analysis to label the food supplements.
  • Preservative testing in formulations.                                                                                                   

Analytical Method Development and Validation : Our professional scientists have extensive experience in analytical chemistry and routinely provide method development and validation for Herbal, neutraceuticals and stability testing. Methods are validated to current USP/ICH guidelines.
The objective of the analytical procedure should be clearly understood since this will govern the validation characteristics which need to be evaluated. Typical validation characteristics which should be considered are listed below:

Intermediate Precision
Detection Limit
Quantitation Limit

Each of these validation characteristics is defined in the attached Glossary. The table lists those validation characteristics regarded as the most important for the validation of different types of analytical procedures. This list should be considered typical for the analytical procedures cited but occasional exceptions should be dealt with on a case-by-case basis. It should be noted that robustness is not listed in the table but should be considered at an appropriate stage in the development of the analytical procedure.

Furthermore revalidation may be necessary in the following circumstances:
- changes in the synthesis of the drug substance;
- changes in the composition of the finished product;
- changes in the analytical procedure.

The degree of revalidation required depends on the nature of the changes. Certain other changes may require validation as well.

Toxicity : Toxicity Recent adverse events have clearly shown that all Herbal products are not free from side effects and toxicity. Products that have been confirmed to have bioefficacy can then be taken up for safety studies to determine possible side effects, adverse reactions and the maximum tolerable dosages. We undertake acute, sub-acute and chronic toxicity studies in animals.

The assumption that herbal medications only have beneficial effects have proven to be incorrect and the literature reports citing problems associated with herbal preparations use are increasing. Hence the evaluation of safety aspects should have priority. Most of the adverse drug reactions to phytomedicines and toxicity could be attributed mainly due to contamination or substitution of the plant material. Contaminants most likely to be found in medicinal herbs are heavy metals, microorganisms, pesticides / herbicides and radioactive isotopes. These contaminants cannot be excluded completely but may be significantly reduced by proper cultivation and harvesting. Any one of the factors - collection, preparation, dispensing, packaging and dosage can be the cause of toxicity.

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Stability Profile : Stability testing is necessary to ensure the product is of acceptable quality throughout its entire storage period. In order to do this, it is necessary to monitor compliance of the product with a suitable quality specification throughout the shelf life. It is not acceptable to only test at the time of expiry, for example, on a retention sample (even though the results of this type of testing may provide useful information about the overall stability of the product).

Stability testing is useful for :

  • Guiding formulation development
  • Selecting packaging materials
  • Defining expiration dating
  • Selecting labeling text
  • Monitoring the quality of marketed formulations using a sampling of
    batches made during production manufacturing

We at THS carry out the stability studies as per the ICH guidelines and provides the following services to support stability testing :

  • Study design, in cooperation with the client
  • Protocol development for client approval
  • Storage of stability samples (alternatively, storage may be performed
    by the client and ASI may receive samples for testing)
  • Testing of stability samples
  • Interim stability reports, provided after each testing interval
  • A final stability report after the last testing interval
  • QA review of reports and data.
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Toxicity : Toxicity Recent adverse events have clearly shown that all Herbal products are not free from side effects and toxicity. Products that have been confirmed to have bioefficacy can then be taken up for safety studies to determine possible side effects, adverse reactions and the maximum tolerable dosages. We undertake acute, sub-acute and chronic toxicity studies in animals.

Animal studies: We at THS undertake systematic animal studies of herbal extracts and formulations by utilizing appropriate models.
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Clinical Data : The common belief that "if a polyherbal product has been prepared as per the traditional system of medicine it is bound to be safe and effective" is not true. If you would like a herbal product to have an edge over the competition then it needs to have a health benefit claim. Well designed Double Blind Randomized Clinical trials can prove such health claims. India has now become the favorite destination to conduct Clinical Research due to modern facilities, high patient population and advanced data management skills

We at THS has a protocol designed to meet the specific requirements of the clients in the field of clinical registration of new pharmaceutical products from phase I to phase IV, including Bioequivalence, Bioavailability, Pharmacokinetic/Pharmacodynamic studies, Statistical Analysis and Data Management strictly adhering to ICH and GCP guidelines. The company offers competitive and high quality clinical trial services to domestic and international pharmaceutical and Bio-Pharmaceutical companies.
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Serving Customers Globally

Total Herb Solutions Private Limited - India
Total Herb Solutions USA / America - Brazil,Spain,Greece,France,Finland,Germany,Gibralter,Italy,Ireland,Poland,Portugal,Spain
Total Herb Solutions UK / Europe - North America - Mexico,Panama,Cuba,Canada

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