REGULATERY AFFAIRS SERVICES IN PUNE
Managing regulatory affairs in a pharma company is not a child-play especially when you have several other activities to handle. We at Lifepoint Research provide thorough professional regulatory affairs services in pune.know more.
Different Types of Clinical Research
NDA and ANDA
Filing of NDAs and ANDAs in India and the US, as well as MAs in Europe, Canada, Asia Pacific, Gulf countries, and semi-regulated countries.
eCTD/NeeS Dossier
Publishing services, eCTD/NeeS dossier compilation, verification, validation, and lifecycle management for all regulated markets.
Depending on the research objective, our team of experts conduct clinical research of the following types:
Diagnostic Research
Diagnostic research includes the diagnostic tests of patients who show symptoms of the disease or condition.
Epidemiological studies
It involves the study of the fraction and pattern of causes/risk factors of health-related states and events in specified populations.
Quality of Life Research
This type of clinical research is devoted to exploring ways to comfort and improve the quality of life for patients with chronic diseases.
Screening Research
Screening research evaluates new tests for detecting certain health conditions and diseases such as cancer before symptoms are present.
Prevention Research
The role of prevention researchers includes working out better ways to prevent disorders from developing or returning. The prevention research includes the study of medicines, vaccines, vitamins, minerals, or lifestyle changes.
Genetic studies
Genetic studies include the study of inheritance and the mapping of disease genes. The goal of this type of clinical research is to explore ways in which a person’s genes make them more or less likely to develop a disorder.
Treatment Research
Treatment research is essential to find out which treatments work better for patients. It generally involves an intervention such as medication, new devices, or new approaches to surgeries.
Our Clinical Research Services
Lifepoint Research offers an array of services in clinical research. Some of them are as follows:
Phase 1 is the earliest phase of trials. It includes giving the best dose of a new drug to a small scale of trial subjects to check the safety of the drug.
The aim of the Phase 2 trial is to develop an understanding of drug metabolism by testing it on a small number of patients.
In this phase, a large number of patients are subjected to the drug test. This is done to obtain the safety and efficacy of the drug.
Phase 4 trials are run after the drug is licensed. It aims to study the side effects caused over time by a new treatment after it is marketed.
Phase 1 is the earliest phase of trials. It includes giving the best dose of a new drug to a small scale of trial subjects to check the safety of the drug.
The aim of the Phase 2 trial is to develop an understanding of drug metabolism by testing it on a small number of patients.
In this phase, a large number of patients are subjected to the drug test. This is done to obtain the safety and efficacy of the drug.
Phase 4 trials are run after the drug is licensed. It aims to study the side effects caused over time by a new treatment after it is marketed.
Listed below are the other important clinical research services in Pune that we provide to our customers:
- Regulatory affairs
- Site selection
- Clinical safety services
- Clinical operations
- Investigator site selection
- Site selection and management
- Patient recruitment and retention
What are the potential benefits of Clinical Research?
The potential benefits of clinical research include:
- It provides insights and answers about the safety and effectiveness of drugs and other therapies.
- It gives us the access to experimental and new treatments
- It provides us with the knowledge that may benefit us in the future
- You get additional care and more frequent health check-ups
- Clinical research enables us to play a more active role in our own healthcare
At Lifepoint Research, we have a team of great professionals who conduct thorough and transparent clinical research and deliver promising results.
Submissions
RA in Clinical Trial Application
- Compilation of CMC, pre-clinical, and clinical data for IND submission.
- IND submission for the United States, Europe, and other regulated and semi-regulated markets.
- CTA filing in various countries such as Europe, the United States, and other regulated and semi-regulated markets.
Active Pharmaceutical Ingredients (API): DMF, ASMF, and CEP / COS Compilation and Filing
- Compilation in CTD, ACTD, eCTD publishing, and Country Specific Dossier
- Labeling in the United States Food and Drug Administration, Health Canada, the European Union, and other markets
- Applications for Marketing
- CMC Consulting Services
Lifepoint Research are dedicated to offering expert assistance in drug development programs. This includes regulatory support for clinical trials and the development of a new chemical entity (NCE). Our diligence and competence to get fillings done in the most efficient way is what gives us an edge. With us, you can always expect proficient regulatory affairs services in Pune in a methodical and stepwise manner.
