Our Bio-Analytical department has been supporting client’s project in the areas of method development and method validation, clinical sample analysis, reporting and submission since the company’s inception.
Our dedicated and knowledgeable scientists are well-trained in GLP and GCP regulations and have provided data of the highest quality to our clients.
The team uses state-of-the-art instruments, such as LC-MS/MS, UPLC, HPLC to complete projects with the highest data quality (AB SCIEX 4000, 4200,3200 & XEVO TQS XEVO TQMS)
All procedures are as per principles of GLP and in compliance with applicable regulatory guidelines like USFDA, WHO, ANVISA, NPRA and EMA, and so on.
The team comprises of well-trained and experienced scientists in method development of simple to complex drugs and metabolites including endogenous substances, achiral and chiral assays.
In addition, MAKOLET has expertise in offering the services for the conduct of Invitro BA/BE biowaiver studies based on BCS classification system.
Bioanalysis plays a critical role in drug development and we make sure to deliver accurate and reliable data subject to scientific and regulatory review that leads to the success of your preclinical and clinical trials. Our bioanalytical laboratories will offer a variety of techniques and technology platforms to meet the customer needs. At Makolet, we are dedicated to offer detailed bioanalytical reports that aid in understanding and estimating the process involved in a research.
To meet critical deadlines, we help in selecting the most appropriate analytical methodology with best standard operating procedures and we will guide you from the early discovery scientific stages to the later clinical stage. We also offer strategic solutions and help you in regulatory challenges. Our research scientists are active contributors to the regulatory discussions and aid you to generate high quality results. Our team comprises qualified researchers with vast experience in BA/BE. We focused on delivering accurate, high quality results in a timely, secured and cost effective manner.