Ayurvedic, Pharmaceutical and Herbal (APH) Industry Consultancy Services

We provide Chemistry, Manufacturing, and Control (CMC), Clinical and non-clinical consulting services to the Ayurvedic, Herbal and Pharmaceutical industries. Our expertise covers the range from due diligence and pre-clinical development to market registration.

• Chemistry, Manufacturing and Controls strategy and tasks

• Due diligence and drug candidate evaluation

• Sourcing and oversight of analytical, synthetic, and formulation development

• Authoring and review of regulatory documents

• Regulatory functions

• Advice on Herbal and Ayurvedic product development

• Non-clinical functions including toxicology

• Organizational development and training in the CMC area

Success in drug development depends on a complete team of professionals. We are in association with a range of highly experienced professionals whose expertise is quickly available to the client.

Associates

We assembled a team of experienced associates to cover a wide range of the CMC and non-clinical functions. These associates have extensive experience in their respective fields and demonstrated effectiveness in working on a development team. They see development events in a perspective developed over many projects and 10 to 25 years of experience. 

Mission

Our goal is to provide a superior quality of consulting services, both as insight and work product. The purpose is to facilitate the efficient development of Ayurvedic, Herbal and Pharmaceutical products to meet patient needs and develop value for the client. We seek to be consultants that contribute real work and advance the project, rather than just propose additional work for the client.

Formulation and Product development 

We at APH have the capability to assist our customers in formulation development in regards to ancient ayurvedic literature to develop a new formulation depending on the requirement of the customer. Our techincal expertise can also assist in the improvement of exisisting formulation for better efficacy. We have helped our esteemed customers to develop time tested new herbal formulations as well as modern nutraceutical formulations.

Our formulation development capabilities include :

• Feasibility study

• Formulation composition

• Designing of dosage form

• Process optimization

• Scale up

New Concept Development / New Project 

Our team comprises of botanists, process technologists, analysts, and clinical pharmacologists, market researchers and business development executives who in turn ensure the work that we deliver is of high quality and efficacy.

What we mean by new concept or project development, is that we can help people to satisfy their requirements and needs by providing professional consultancy for setting up manufacturing unit of natural products of any plant species and herbs. Our services also include nutraceuitcals, functional foods, dietary supplements and natural food colors. We have the capability to convert ideas to formulations and formulations into products.

We help in conceptualization of ideas beginning from detailed market survey both domestic and international to studying the raw material. To assisting in technology to be used, equipments, financial projections, plant layout, running trial batches, SOPs, helping in deciding the type and quality of the products to be produced, Operational convenience and accessibility , validation and the regulatory requirements to be met for the project.

Standardization / Method development and validation 

We are experts in the development, standardization, validation and transfer of analytical methods for natural products. Method development and validation services are important for a customer to understand all the difficulties associated with natural product development. We also deliver robust analytical methods that are either fully validated or validation-ready and easily transferable.

• Testing and standardisation of herbal medicines

• 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.

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 :

• Accuracy

• Precision

• Repeatability

• Intermediate Precision

• Specificity

• Detection Limit

• Quantitation Limit

• Linearity

• Range

Identification Of Herbs and Unknown Formulation 

Identification of unknown formulation 

Now-a-days, the modern techniques are utilized to understand the days old formulation which were prescribed by ayurvedacharyas, vaidyas and hakims. Our team can help these kind of customers in identifying the ingredients in the formulation by various trial and error procedures.

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.

Regulatory Services 

Good quality product literature is one of the keys to successful regulatory approval hence THS offers Regulatory expertise to export oriented Herbal and Nutracetical companies in the development of following documents for obtaining Market Authorization,

• Dossier preparation for regulatory submissions for DSHEA, GRAS, NDI, etc

• Dossier preparation for funding purposes

• Preparation of Chemistry Manufacturing & Controls (CMC) Dossier

• Preparation of Investigator’s Drug Brochure (IDB)

• Search & Consulting for Good Agricultural Practices (GAP) compliance

• Search & Consulting for Botanical Drug Product IND submissions

• DMF – Drug Master File

Market Report 

We also provide market survey report as well as study report for the client who are planning to enter the new industry i.e natural product