Analytical Method Development:
We provide the service of developing new analytical methods for testing of Pharmaceutical drug substances of various dosage forms, excipients, active pharmaceutical ingredients and fixed dose combinations.
We provide the service of developing new analytical methods for testing of Pharmaceutical drug substances of various dosage forms, excipients, active pharmaceutical ingredients and fixed dose combinations.
Assay of single and fixed dose combinations.
Stability indicating assay methods
Related substances profiling methods
Stress studies
Single and multidrug methods for cleaning validation studies
Analytical methods for critical excipients like preservatives and stabilizers
Methods for multivitamin formulations
All methods developed by our lab are fully validated as per the current requirements laid down in the ICH guidelines Q2(R1).
Over the years we have developed and validated hundreds of analytical methods. Some of the methods developed independently by our team have been published in reputed journals and presented at conference; a list of some of the publications can be seen on our publications page.
We are confident that if you have an analytical problem we will have a solution for it!
Validation of analytical procedures used in the pharmaceutical laboratory is critical to ensure that they are suitable for the analysis is being carried out.
Analytical method validation reports form an integral part of product dossiers for the approval of pharmaceutical products and pharmaceutical substances. Nowadays all countries require that analytical method validation reports with complete chromatograms and raw data must be submitted along with the dossiers for evaluation and approval of the products.
Our laboratory has carried out method validation studies for leading pharmaceutical companies in India and we follow a systematic process for conducting validation studies so that the correct data can be submitted in a time bound manner.
The exact analytical method to be followed is shared in the form of a standard testing procedure for approval
After the approval of the standard testing procedure a draft method validation protocol is developed
The draft method validation protocol is submitted to the client for approval
If there are any recommendations from the client these are incorporated into the method validation protocol
A final method validation protocol is issued
Method validation studies are initiated and carried out as per the protocol
After completion of the method validation or draft method validation report is prepared and submitted to the client along with the raw data
Once the client gives the go-ahead for preparation of final report the final report incorporating any suggestions a correction this prepared
The final report along with all raw data as well as soft copy of the chromatographic data is submitted to the client
If there are any queries from the regulatory bodies on the method validation is data submitted we help our clients answer these queries and also carry out additional experiment work if there is a need
Stability testing is integral to developing new pharmaceutical products and active pharmaceutical ingredients, to establish their shelf life or expiry date. It is also equally important along with ongoing routine manufacturing to monitor product quality as a function of time. We provide a complete solution to your requirements of Stability Studies for Shelf Life Estimation during
Product Development
Product Shelf life evaluation
Packing Material development & change over
For Product Registration in Global Markets
Critical supplier change
Our pharmaceutical testing laboratory has been performing third-party testing of pharmaceutical finished products and we have been supporting our customers in the pharmaceutical industry for testing their pharmaceutical drug products for –
Product release testing
Form 39 reports for government supplies and tenders
Comparative studies with innovative products developmental stability testing
Process validation studies
Ongoing stability studies
Quality control support for third-party manufacturing sites
Investigating market complaints
Pre-shipment inspection and testing for exports
We offer a complete package of pharmaceutical testing services for finished products for both the domestic as well as export markets.
Our team is experienced and laboratories are well equipped for carrying out the analysis as per pharmacopoeial monographs and also in our specifications given by the clients.
Our services include identity, purity as well as functional testing for various dosage sterile and non-sterile forms like tablets, capsules, syrups, dry syrups, suspensions, suppositories, pessaries, eyedrops, ointments, transdermal patches, small volume parenterals and large volume parenterals,etc.
Besides carrying out routine analysis and release testing our laboratories also perform stability studies and analytical method development and validation studies to support you for your product development and registration in both semi-regulated and highly regulated markets.
We carry out Assay, related substances test, compatibility studies and stress studies on active pharmaceutical ingredients and also develop new analytical method and perform the validation of the methods.
We do not disclose the API details to any different customers so your API methods are safe with us.
We provide application support for any existing methods at your site and also we can develop methods at our lab if samples are provided to us by your lab.
Also we develop your existing methods on our brand columns and deliver it to you. This reduces your efforts, time and most importantly the cost to the organization. Also we guide you regarding, how to increase the column life.
Column Chemistry
HPLC column washing procedures
Approach to Method Development
Systematic steps to Method Validation
Guidelines
We will provide theoretical and practical training of many instruments. We will give training of how to handle instruments, how to care for instruments in industries, Calibration of instruments, Standard operating procedures for all the instruments which are available with us and also which are not available with us.
We will help in the project work for the students from initial to completion of the projects. We will also check the slides that to be presented in the final seminars. We offer mostly 6 months project work for a better and complete Master’s thesis. We will also help in publication of the thesis in reputed and peer reviewed journals.
We also instruct the ways to write research abstracts and papers for national and international seminars and conferences. We have an expert panel of researchers worldwide for necessary guidance.
We will be preparing our students confidently to face interviews. We will make them expert in interview questions for all rounds (HR, Technical, etc). We will also prepare them for group discussions.
There are various guidelines followed in industries for various departments. The plants are approved with various organizations and according to that the guidelines are made. We will make them aware of all the major guidelines.
On technical point of view, we are very strong and our trainers are basically scientists who have worked with different MNC organizations both government (CSIR, DST) and private (Nicolas Piramal, Wockhardt, KHPL, Chromanik Tech, Japan). We will provide training on how to do method validation of drugs, Extraction, Isolation, and Characterization of drugs from Natural products. The method development, interpretation of HPLC chromatograms of Assay and Impurity profiling, NMR and Mass spectra is the real challenging and we will give complete focus on that. Also we will make students aware of process validation, cleaning validation and many more.
We will choose some students who will work for us. We will prepare all for industrial jobs like Production, QA, QC, R&D both formulation and Analytical, Regulatory department. We will be having some industries tied up with us shortly, for fixing interviews and providing jobs for our students.