Teadus Pharma Private Limited is committed to delivering excellence in analytical development, a critical aspect of the pharmaceutical industry. Our state-of-the-art facilities and highly skilled analytical scientists enable us to provide a comprehensive range of analytical services.
Analytical Method Development lies at the core of our capabilities. We follow Quality by Design (QBD) principles to design and develop robust and reliable analytical methods for drug products. Our experienced team utilizes advanced techniques and instrumentation to establish methods that ensure accurate and precise analysis of key quality attributes, enabling efficient formulation development and quality control.
Method Validation and Transfer are essential steps to ensure the reliability and consistency of analytical methods. Our team conducts thorough validation studies in compliance with regulatory guidelines to demonstrate method accuracy, precision, specificity, and robustness. We also offer method transfer services to seamlessly transition validated methods between laboratories, ensuring consistent analytical results across different sites.
API Method Verification and Transfer is a critical process to verify and transfer analytical methods specific to active pharmaceutical ingredients (APIs). Our experts ensure that the methods developed for API analysis are accurate, reliable, and suitable for use, facilitating seamless integration into formulation development and quality control processes.
Cleaning Method Development and Method Transfer are crucial for ensuring proper cleaning validation of manufacturing equipment. We develop and transfer analytical methods that accurately determine the presence of residual drug substances or contaminants on equipment surfaces, ensuring compliance with regulatory requirements and maintaining product safety and quality.
Reverse Engineering Studies of Innovator Products involve a comprehensive analysis of the reference or innovator product to understand its formulation and manufacturing process. Our skilled scientists employ cutting-edge techniques to dissect and analyze the innovator product, providing valuable insights for formulation development and generic product equivalency studies.
Stability Studies are conducted to assess the product’s stability under various environmental conditions over time. Our state-of-the-art stability chambers and meticulous monitoring allow us to evaluate the product’s shelf life, degradation pathways, and storage requirements, ensuring product quality and safety throughout its intended shelf life.
Pharmaceutical Equivalency Studies and Multimedia Dissolution Studies play a crucial role in establishing the equivalence of generic products to the reference or innovator products. Our skilled scientists design and conduct comparative studies to evaluate the dissolution profiles and pharmaceutical equivalency of generic products, providing critical data for regulatory submissions and ensuring the efficacy and performance of generic formulations.
At Teadus Pharma, our commitment to analytical development drives us to continuously enhance our capabilities, ensuring accurate, reliable, and efficient analytical solutions. Trust us to deliver comprehensive analytical services that facilitate successful formulation development, quality control, and regulatory compliance.
At Teadus Pharma, we have established a state-of-the-art analytical infrastructure to support our rigorous testing and analysis processes. Our advanced analytical facilities are equipped with cutting-edge instruments and equipment, enabling us to deliver accurate and reliable analytical results for our clients. We prioritize the use of industry-leading technology and maintain strict quality control measures to ensure the highest standards of precision and compliance.
Here are some key components of our analytical infrastructure:
At Teadus Pharma, we understand the significance of robust and advanced analytical infrastructure in delivering accurate and reliable results. Our investment in cutting-edge instruments and equipment, combined with the expertise of our analytical team, ensures that we meet and exceed the analytical requirements of our clients and adhere to stringent quality standards.
Teadus Pharma Private Limited takes pride in providing a wide range of comprehensive services specifically tailored for injectable dosage forms. Our commitment to excellence ensures that every aspect of product development and manufacturing is executed with utmost precision and adherence to regulatory standards.
At Teadus Pharma, we prioritize excellence, precision, and compliance throughout the entire injectable product development process. Partner with us to benefit from our expertise and ensure the successful development and manufacturing of injectable dosage forms.
In our Clinical division, we offer a wide range of services to support the transition from pre-clinical studies to clinical trials. Our dedicated team of experts focuses on ensuring the safety, efficacy, and scalability of the drug candidate.
One of our key areas of expertise is Non-Infringing Route Development and Optimization, where we explore alternative synthetic routes that comply with intellectual property regulations while maintaining efficiency and cost-effectiveness. This allows us to overcome any potential patent-related hurdles.
We also conduct QbD-DOE (Quality by Design-Design of Experiments) studies, which involve a systematic evaluation of critical quality attributes (CQA) and critical process parameters (CPP). This approach helps us identify and optimize the factors that impact the quality and performance of the drug candidate.
Process Characterization studies play a vital role in understanding the robustness and reliability of the manufacturing process. We conduct Spike & Purging studies and employ the One Factor at a Time (OFAT) approach to evaluate and optimize process parameters.
To ensure process safety and efficiency, we conduct Process Engineering Assessments, including Failure Mode and Effects Analysis (FMEA) and Process Safety/Hazop Assessments. These evaluations help identify and mitigate potential risks and hazards associated with the manufacturing process.
A comprehensive Polymorph Study is also conducted to assess the different crystalline forms of the drug candidate, which can impact its stability, solubility, and bioavailability.
In the Clinical division, we place strong emphasis on analytical method validation to ensure accurate and reliable analysis of the drug candidate at different stages of development. Our Phase-Appropriate Analytical Method Validation approach aligns with regulatory requirements and ensures method suitability for clinical trials.
For large-scale manufacturing, we offer Multi Kilo synthesis under cGMP conditions, adhering to stringent quality standards to meet regulatory requirements.
Lastly, we provide Formulation Support to optimize the drug candidate’s formulation for clinical trials, taking into account factors such as stability, bioavailability, and patient compliance.
Our Clinical services are designed to accelerate the transition from pre-clinical to clinical stages, while ensuring the safety, quality, and efficacy of the drug candidate, ultimately advancing its path towards successful commercialization.
At Teadus Pharma, our goal is to provide our clients with exceptional technical expertise, grounded in our specialist chemistry knowledge and robust project management capabilities. We are committed to delivering excellence, guided by internationally recognized ethical and quality standards.
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