KMS Pharma supports pharmaceutical development with analytical services that help teams evaluate product quality, investigate impurities, study stability and prepare relevant analytical documentation. The work can begin during early formulation development and continue through method validation, transfer and regulatory submission, depending on the agreed project scope.
When evaluating a Pharmaceutical Analytical Development Company in Chennai, consider its method development capabilities, analytical instrumentation, specialised testing experience, stability support and ability to document results clearly. Analytical requirements differ by product, so the programme should reflect the molecule, dosage form, development stage and intended regulatory pathway.
Pharmaceutical Analytical Development Company in Chennai
Analytical development helps establish how a pharmaceutical product will be tested and how its relevant quality attributes will be measured. Methods may be needed to assess assay, impurities, dissolution, stability and other product-specific characteristics. The approach depends on the active ingredient, formulation, intended testing purpose and applicable requirements.
KMS Pharma provides analytical development support for pharmaceutical products from early formulation work to regulatory documentation. The team works alongside formulation development and quality functions to generate useful analytical data, assess method performance and support decisions throughout the development programme.
Analytical method development and validation are different but connected activities. Development establishes a suitable method for its intended use, while validation evaluates whether the method meets predefined performance criteria. Transfer and verification may also be required when methods move between laboratories or sites.
Analytical method development
Develop methods around the product, the attributes being measured and the purpose for which the results will be used.
Validation and transfer
Assess method performance and support transfer or verification activities according to the agreed study requirements.
20+ years of experience
KMS Pharma states more than 20 years of analytical R&D experience supporting pharmaceutical development activities.
The objective is to produce dependable analytical data and methods that are suitable for their intended purpose, with documentation that supports the next development decision.
Analytical method development, validation and transfer
An analytical method must be appropriate for the product and the decision it is expected to support. A method used during early development may need further assessment as the formulation, manufacturing process or regulatory requirements become more clearly defined.
Method development
Develop analytical methods for finished products and intermediates, considering the product's critical quality attributes and the intended analytical purpose.
Method validation
Evaluate method performance against predefined acceptance criteria and applicable requirements to establish suitability for the intended use.
Method transfer
Support transfer to a receiving laboratory or manufacturing site, with appropriate documentation and data to evaluate method performance at the receiving location.
Method verification and cleaning methods
Support verification of compendial or transferred methods, as well as cleaning-method development and validation where included in the project scope.
Method lifecycle activities should be planned according to the product's stage of development and intended use. The required tests, acceptance criteria, transfer arrangements and documentation should be agreed upon for each programme.
Impurity profiling, elemental impurities and extractables and leachables
Impurity assessment is an important part of pharmaceutical analytical development. Understanding the identity, levels and potential sources of impurities can help development teams evaluate product quality and identify issues that may need further investigation before regulatory submission.
The analytical programme may consider impurities associated with the active ingredient, formulation components, manufacturing process or packaging system. The appropriate assessment depends on the product, available information and applicable regulatory expectations.
Impurity identification and characterisation
Investigate relevant impurity profiles and support characterisation activities based on the analytical requirements of the product.
ICH Q3D assessment
Support evaluation of elemental impurities in line with relevant ICH Q3D considerations and the requirements of the product.
Extractables and leachables
Assess extractables and leachables requirements where relevant to the product, its packaging or its container-closure system.
Nitrosamine assessment
Support nitrosamine-related analytical studies and risk assessment according to the product and the agreed scope of work.
Preformulation studies
Generate relevant analytical information to support early formulation assessment and product development decisions.
Analytical problem assessment
Use suitable analytical data and investigations to help understand product or method-related observations.
Impurity, elemental impurity and extractables and leachables assessments are product-specific. The study design and any required follow-up testing should be established with reference to the intended market, available evidence and applicable guidance.
Specialised analytical testing for pharmaceutical products
Some products require analytical studies beyond routine assay and impurity testing. Specialised studies can help investigate product performance, delivery characteristics, compatibility or use-specific questions. The required method and study design depend on the formulation and the objective of the assessment.
Nitrosamine studies: Analytical work to support the assessment of nitrosamine-related risks and product-specific requirements.
NG tube studies: Evaluation of relevant product attributes when administration through a nasogastric tube is part of the intended use or development question.
Elemental impurities: Analytical assessment to support evaluation against relevant product requirements and ICH Q3D considerations.
IVRT and IVPT studies: In vitro release and in vitro permeation testing for relevant topical and other suitable product development programmes.
Phosphate binding studies: Product-specific studies to assess phosphate-binding performance where relevant to the development objective.
Specialised analytical studies should be selected according to the question being investigated. Before a programme begins, it is useful to define the study objective, test method, controls, acceptance criteria where applicable and the intended use of the results.
Pharmaceutical stability studies in line with ICH guidance
Stability studies help establish how a pharmaceutical product's quality attributes change over time under defined storage conditions. The results support development decisions, help identify potential formulation weaknesses and contribute to the evidence used when establishing a proposed shelf life.
KMS Pharma's stated analytical capabilities include development stability studies using temperature- and humidity-controlled stability chambers and photostability chambers. The study design should reflect the product's characteristics, dosage form, packaging, stage of development and relevant ICH guidance.
Define the stability programme
Identify the product attributes to be monitored, the relevant storage conditions and the testing schedule appropriate to the study.
Monitor product quality
Generate analytical data at planned intervals to evaluate changes in relevant product characteristics during storage.
Review trends and observations
Assess the data for trends or changes that may require additional investigation or consideration during formulation development.
Document the findings
Compile the relevant results and supporting documentation for the development programme and its next-stage decisions.
Stability results must be interpreted in the context of the study design and available data. A proposed shelf life or storage condition should be supported by the relevant evidence and applicable regulatory requirements.
Dissolution testing and pharmaceutical product performance
Product performance testing provides information about how a dosage form behaves under defined test conditions. Depending on the formulation and development objective, testing may be used to assess dissolution, drug release, permeation or particle-size characteristics.
KMS Pharma's stated analytical capabilities include dissolution testing with USP Apparatus I, II and III, intrinsic dissolution, Franz diffusion cell studies for topical products and particle-size analysis from micron to nano scale.
USP Apparatus I, II and III
Dissolution testing with autosampler support for relevant pharmaceutical product development and performance assessments.
Intrinsic dissolution testing
Studies to evaluate intrinsic dissolution characteristics where appropriate to the drug substance and development question.
Franz diffusion cell studies
Diffusion studies for suitable topical formulations as part of product performance assessment.
Micron-to-nano particle sizing
Particle-size analysis to support relevant material characterisation and formulation development requirements.
The choice of performance test should be justified by the product and the question being investigated. Study conditions, comparison criteria and interpretation of results need to be defined according to the intended purpose and applicable requirements.
Analytical documentation for pharmaceutical regulatory submissions
Analytical results need to be supported by clear methods, traceable data and documentation that explains how conclusions were reached. During a regulatory submission, the analytical sections should accurately describe the methods used, their suitability for the intended purpose and the relevant evidence generated during development.
KMS Pharma's analytical team supports preparation of analytical sections of regulatory dossiers and responses to questions relating to analytical data. The supplied service information also notes experience supporting submissions for the US and Europe, including QbR, OOS and OOT investigations and query resolution.
Analytical dossier sections: Prepare relevant analytical information based on the methods, studies and data available for the product.
Regulatory query support: Help address questions relating to analytical methods, results and supporting documentation within the agreed scope.
OOS investigations: Support investigations into out-of-specification results using appropriate procedures and documented evidence.
OOT investigations: Assess out-of-trend observations and document relevant findings according to the investigation requirements.
Method and data traceability: Maintain a clear link between the analytical method, test results, investigation records and the conclusions reported.
Regulatory requirements depend on the product, target market and submission pathway. The precise dossier deliverables, submission responsibilities and query-response scope should be agreed before the work begins.
Analytical instruments and laboratory capabilities
Analytical instruments are selected according to the substance being measured, the test method and the required sensitivity or measurement range. A combination of chromatographic, mass spectrometric, elemental analysis and product-performance equipment can support different types of pharmaceutical analytical work.
The following instruments and systems are listed in the information supplied for KMS Pharma. Confirm the current availability, method suitability and project-specific scope directly with the team.
LC-MS/MS
Liquid chromatography–tandem mass spectrometry for suitable analytical applications, subject to method and project requirements.
GC-MS
Gas chromatography–mass spectrometry for applicable analytical investigations and testing requirements.
ICP-MS
Inductively coupled plasma mass spectrometry for suitable elemental analysis applications.
Shimadzu HPLC with UV detection
High-performance liquid chromatography equipment for relevant method development and analytical testing.
Dionex ion chromatography
Ion chromatography for applicable analytical methods and product-related testing needs.
UV and UV-visible spectrophotometers
Spectrophotometric systems for suitable analytical measurements and development applications.
Electrolab USP Apparatus I, II and III
Dissolution testing systems for relevant dosage forms and product performance studies.
Franz diffusion apparatus
Equipment for suitable in vitro diffusion studies, including relevant topical product assessments.
Particle-size analyser
Particle-size measurement for samples in the stated micron-to-nano range, subject to method suitability.
Stability and photostability chambers
Controlled chambers to support relevant stability and photostability study programmes.
Supporting laboratory instruments
Karl Fischer titrator, viscometer and conductivity meter for applicable analytical and physical measurements.
Equipment alone does not establish that a method is suitable for a particular product. Method development, validation or verification, instrument suitability and appropriate documentation remain important parts of the analytical programme.
How to choose the right analytical development company in Chennai
The right analytical development partner should understand the product, the purpose of each study and the decisions the resulting data needs to support. Before selecting a service provider, review its experience with the relevant dosage form, analytical methods, specialised testing needs and documentation requirements.
Method development and validation: Confirm that the proposed analytical work matches the product and its intended testing requirements.
Specialised analytical capabilities: Ask about the relevant experience and scope for nitrosamine, elemental impurity, IVRT/IVPT or other specialised studies.
Stability and performance testing: Clarify which stability, dissolution, diffusion and particle-size studies are available for your product.
Instrumentation and method suitability: Check the equipment, method requirements and any limitations relevant to the proposed analysis.
Regulatory documentation: Agree on the analytical reports, dossier sections, investigation support and query responses included in the project.
Defined deliverables: Establish the scope, study milestones, responsibilities, timelines and data outputs before starting work.
A clear project brief helps the analytical team understand the product and determine the appropriate work. Capabilities, equipment availability, timelines and deliverables should be confirmed directly for the specific programme.
Discuss your pharmaceutical analytical development requirements
Planning analytical method development, validation, impurity assessment, stability studies or specialised product testing? Contact KMS Pharma to discuss your molecule, dosage form, development stage and the analytical support relevant to your project.
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