Product Development

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Product Development

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At Saigates Scientific Solutions, we understand how crucial it is to plan and develop a successful and efficient pharmaceutical product. As a scientific solutions company, we are uniquely positioned to assist our clients in developing a new drug. Since we are a team of multi-disciplinary experts, we are capable to perform different functions required for new drug development.

Within the circumference of new project requirement, our team of experts at Saigates Scientific Solutions assist clients in the following tasks:

  • – Project managing, monitoring and, if required, outsourcing.
  • – Critically analysing product formulation and processes best suited to that specific drug category.
  • – Technical documents write up and review (SOPs and work instructions)
  • – GLP compliance: Auditing the laboratories for GxP compliance can be performed for the clients on their request.
  • – Study plan write up and review
  • – Client Confidentiality Agreement is prepared before the initiation of any project to ensure client project information is safeguarded at all times.
  • – Specific literature search related to the product or a country that the client intends to develop or market the product.

Saigates Scientific Solution specialises in new product development. The company provides a complete evaluation of the material throughout all stages following high scientific standards. The team at Saigates conducts formulation development work for the new product or reformulation work for the existing product to improve the performance of the product.

Pre-formulation work that involves solubility (saturated and visual), excipient compatibility and stability of the API can be performed to understand the scientific behaviour of the product to be developed.

Product development work can be planned and performed for solid, semi-solid and liquid formulations. Saigates Scientific Solutions assists clients form study design, development and analysis of the materials throughout the product development pipeline.

Saigates Scientific Solutions has a trusted network of experienced scientists to help our clients develop, implement and validate various analytical methods for the analysis of the API and in order to detect the impurities in the product.

We can help you perform the following procedures for your specific product requirement:

  • – Method development and validation as per ICH requirements.
  • – Various analytical tests to quantify the levels of materials in formulation in order to check whether the product meets the specification, further producing reports.
  • – Stress modelling for drug substances and drug products.
  • – Drug release testing & stability testing, data interpretation and summary reports.
  • – Setting specification by initial experiments
  • – Analytical method transfer
  • – Method development and validation
  • – Isolation and identification of impurities, degradation products and metabolites.
  • – OOS and OOT investigation
  • – Setting of Specification

Saigates, with its strong association with reputed laboratories, engages further to help clients perform the necessary tests as per their product requirement. Timelines are given first priority with no slips in quality of work.

It is a given fact that not all the technology is as easy and smooth to transfer from R&D to manufacturing site. Saigates and its skilled consultants help clients to perform a smooth technology transfer by taking charge of the entire transfer process.

Saigates Scientific Solutions provides the following support to clients in need of a smooth technology transfer:

  • – Manufacturing method transfer
  • – Packaging & cleaning method transfer
  • – Technical and regulatory gap analysis of both the R&D process and manufacturing site
  • – Planning and documentation of the transfers

 

At Saigates Scientific Solutions, we provide end-to-end assistance to our clients ensuring common mistakes in technology transfer is avoided. This leads to a smooth process, saves them time and money, and gives us client satisfaction.