Bioequivalence Studies
BA/BE Studies conducted at MTRL are in strict compliance with International Regulatory Requirements.
Read More →Bioanalytical Services
Our Bioanalytical department has been supporting client’s project in the areas of method development validation.
Read More →Diagnostics
Our team of expert statisticians, SAS programmers, and medical writers have the qualifications, training, and experience necessary to deliver top-notch data analysis services.
Read More →Medical Writing
Our standard reports are prepared to conform to the requirements of the ICH E3 "Structure and Content of Clinical Study Reports". Past experience and regulatory expertise ensures that reports are written to minimize any possible delay in regulatory approvals.
Read More →Regulatory Affairs
Qualified, trained & experienced team of statisticians, SAS programmers, pharmacokineticists, and medical writers providing high quality data analysis & statistical report writing in accordance with regulatory standards.
Read More →01Bioequivalence Studies
Bioequivalence Studies
MTRL conducts BA/BE studies in accordance with international regulatory standards and is monitored by an independent quality assurance department. We have a large database of over 32,000 volunteers, including healthy and special populations, and female volunteers. We have completed more than 1700 BA/BE Studies and successfully cleared many international (USD FDA, EMA, ANVISA, NPRA etc) regulatory audits. We also have a dedicated volunteer mobilization team to ensure timely completion of studies.
02Bioanalytical Science
Bioanalytical Science
Our Bioanalytical department has been providing support to clients since the company's establishment, offering services such as method development, validation, sample analysis, reporting, and submission. Our team is composed of knowledgeable scientists who are well-trained in GLP and GCP regulations and utilizes state-of-the-art instruments like LC-MS/MS, UPLC, HPLC to produce data of the highest quality. All procedures follow GLP principles and comply with relevant regulatory guidelines from organizations like USFDA, WHO, ANVISA, NPRA, EMA, and others. Our team also has experience in method development for various substances, including simple and complex drugs and metabolites, endogenous substances, and chiral and achiral assays.
03Diagnostics
Diagnostics
Our diagnostics services include Biochemistry, Serology, Haematology, Clinical Pathology, and Endocrinology, which are used to diagnose and monitor diseases and conditions.
MTR's molecular diagnostics services include various genetic and DNA tests. These services include Pre-Natal Tests, Post-Natal Tests, Infectious-Test Panels, Pre-Implantation Genetic Testing for Aneuploidies-PGT-A(PGS)Packages, Pre-Implantation Genetic Testing for Structural Re-arrangements and Aneuploidies, Cytogenetic Evaluation, Endometrium Health Packages, and Carrier Screening. These tests are used to identify genetic predispositions to diseases, screen for inherited disorders, and determine if a person is a carrier of genetic mutations that could be passed on to their offspring. MTR's advanced testing and diagnostic services help healthcare providers make accurate diagnoses, offer personalized treatments, and improve patient outcomes.
04Medical Writing
Medical Writing
Our Medical writing involves presenting high-quality data in compliance with global regulatory standards. This includes creating integrated study reports in eCTD format, preparing FDA Summary Tables, developing customized reports, and creating CS-BE submissions for TPD. Additionally, medical writers can prepare abstracts, manuscripts, publications, and poster presentations, as well as develop study protocols and informed consent forms based on their experience. These reports are written to meet the requirements of the ICH E3 guidelines and ensure timely regulatory approvals.
05Regulatory Affairs
Regulatory Affairs
Scientific Affairs offers expert data analysis, statistical report writing, and pharmacokinetic analysis services, provided by a team of experienced statisticians, SAS programmers, and medical writers. Their work is done to meet regulatory standards and Our Regulatory Affairs handles IRB submissions and liaises with IRB/IEC. They also communicate with regulatory agencies such as FDA, TPD, and EMEA.
06Testimonial
What Our Clients Say!
“MTRL's quality, responsiveness and customer service with both routine and unique requests are exemplary. Their work shows professionalism with a craftsmanship-like pride that is difficult to find now-a-days.”
“My knowledge in this area is not very strong. I knew what I wanted to achieve but wasn’t sure how to get there. MTRL's got me there and I am ecstatic with the results. Thank you so much.”
“The team members from MTRL's were responsive, hard-working and client oriented. It was easy to work with them and they were always willing to take the time to discuss any concerns and respond to questions.”