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Development

Analytical Development

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.

Analytical Infrastructure:

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:

  • UV-Visible Spectrophotometer: Our UV-Visible spectrophotometer is a versatile instrument used for qualitative and quantitative analysis of various compounds. It allows us to measure and analyze the absorption and transmission of light, providing valuable information about the chemical composition and concentration of substances.
  • HPLCs – Agilent: We utilize high-performance liquid chromatography (HPLC) systems from Agilent, a renowned manufacturer in the industry. HPLC is a powerful technique used for separation, identification, and quantification of complex mixtures. Our HPLCs enable us to perform precise and efficient analysis of pharmaceutical compounds, ensuring accurate determination of their purity, potency, and impurity profiles.
  • Stability Chambers: We maintain stability chambers with controlled temperature and humidity conditions to conduct stability studies on our formulations. These chambers provide a controlled environment to simulate real-time storage conditions, allowing us to assess the stability, degradation, and shelf life of our products.
  • Dissolution Tester (Auto and Manual): Our dissolution testers, both automatic and manual, are used to evaluate the release of active pharmaceutical ingredients from solid dosage forms. These testers help us determine the dissolution profile, dissolution rate, and performance of our formulations, ensuring their effectiveness and bioavailability.
  • Water Purification System: We have a dedicated water purification system to ensure a reliable and consistent supply of purified water for analytical testing and formulation processes. This system eliminates impurities, contaminants, and ions from water, maintaining the integrity of our analyses and ensuring accurate results.
  • pH Meters – 5-Point Calibration: Our pH meters undergo a meticulous 5-point calibration process to ensure accurate and reliable pH measurements. These meters are essential for determining the acidity or alkalinity of solutions, which is critical for quality control and formulation development.
  • Other Supporting Equipment: In addition to the above instruments, we also possess a range of supporting equipment that aids in formulation development and analytical testing. This includes microbalances and semi-microbalances for precise weighing, headspace analyzers for gas analysis, DO meters for dissolved oxygen measurements, and centrifuges for sample separation and preparation.

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.

Services for Injectable Dosage forms

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.

  1. Product Development designed as per QBD:
  • Sterilization Method Selection: Our experienced team assists in selecting the most appropriate sterilization method for injectable products, considering factors such as efficacy, product compatibility, and regulatory requirements.
  • Packaging Material Compatibility Studies: We conduct thorough studies to evaluate the compatibility of packaging materials with the formulation, ensuring optimal packaging integrity and product stability throughout its shelf life.
  • Manufacturing Vessel Compatibility Studies: Our experts perform compatibility studies to ensure that the manufacturing vessels used during production do not interact with the formulation, safeguarding product quality and efficacy.
  • Manufacturing Components Compatibility Studies: We assess the compatibility of various components, including filters, tubing, and gaskets, to ensure that they do not adversely affect product quality or introduce any contaminants.
  • Oxygen Sensitivity Studies: We evaluate the sensitivity of the formulation to oxygen exposure, ensuring that appropriate measures are taken to maintain the product’s stability and efficacy.
  • pH Sensitivity Studies: We investigate the impact of different pH levels on the formulation to determine its stability and compatibility, enabling us to optimize the product’s performance.
  • Thermal Cycling Studies: Our team performs rigorous thermal cycling studies to assess the formulation’s stability and integrity under varying temperature conditions, providing valuable insights for storage and transportation.
  • Freeze Thaw Studies: We conduct freeze-thaw studies to evaluate the impact of repeated freezing and thawing cycles on the product’s stability and overall quality.
  • Stability Studies: We offer comprehensive stability studies to assess the formulation’s stability over time, ensuring its efficacy and maintaining product quality throughout its intended shelf life.
  • Photo Stability Studies: Our experts conduct photo stability studies to evaluate the formulation’s response to light exposure, helping us understand and mitigate any potential degradation risks.
  • Filter Validation Studies: We perform filter validation studies to ensure the efficiency and integrity of filtration processes, guaranteeing the removal of particulate matter and ensuring product safety.
  • Delamination Studies: We investigate the potential for delamination in container closure systems, employing advanced analytical techniques to detect and mitigate any risks associated with container integrity.
  • Extractable and Leachable Studies: Our team conducts thorough extractable and leachable studies to identify and quantify any potential chemical substances that may migrate from packaging materials into the product, ensuring product safety and regulatory compliance.
  1. Scale Up / Technology Transfer Activities:
  • Our formulation and analytical scientists collaborate with manufacturing sites, ensuring a seamless execution of analytical method transfer, scale-up activities, and exhibit batch manufacturing.
  • We prepare comprehensive pre-technology transfer documentation, including master formula records, specifications, standard testing procedures, transfer protocols, stability and sampling protocols, and provide them to the manufacturing site, facilitating a smooth transition and maintaining consistency.
  • Our experts review all documents provided by Contract Manufacturing Organizations (CMOs), ensuring alignment with product quality standards and regulatory requirements for finished product method transfer and report finalization.
  • We oversee the execution of scale-up and exhibit batches at manufacturing sites, ensuring that the transition from lab-scale to commercial-scale production is carried out seamlessly, meeting the highest quality standards.
  1. Product Development Report Preparation:
  • We prepare comprehensive product development reports tailored to various markets based on specific regulatory requirements, ensuring compliance and facilitating efficient regulatory submissions.

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.

Clinical

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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