Services - Quantys

BA/BE SERVICES

The majority of generic drugs require pharmacokinetic bioequivalence and bioavailability studies for approval. We have 104 bedded facility divided into 5 clinics and supported by fully equipped 8 bedded ICUs for conducting bioavailability and bioequivalence studies. We offer our clients significant value addition that includes quicker subject/special population recruitment, quality assurance and competitive cost. A team of 50+ qualified, experienced and dedicated employees with over 90+ years of cumulative experience in clinical research and expertise in executing all types of dosage forms.

Under BA/BE services we offer;

PK/PD studies
Single/multiple doses
Fasting/fed condition
Various routes of administration
Implants, patches, injectable, etc.
Healthy volunteers/special population
Immediate/modified-release preparations

Project Management

Our Project Management team oversees the entire project flow right from the stage of first sponsor interaction until the final report dispatch. We also offer post-submission query resolution support till product approval from the regulatory authorities. QCPL offers the concept of client-specific project managers, increasing the ease of communication.

Our project management is responsible for;

Documents' review before finalization of the project.
Setting up project timelines for the awarded projects.
Arranging training a regulatory update on BA/BE studies.
Study updates to sponsor, Regulatory and Ethics committee.
Conduct meetings with the sponsor for their technical queries.
Site aspects of project management from budget management to operational delivery.
Develop contracts and subject enrolment strategies to minimize costs and stay on budget.
Regular effective meetings with all stakeholders of the project throughout the study period.
Develop efficient processes for data management and adverse event reporting to streamline compliance requirements.
Identify and prioritize financial, technical, and legal risks to ensure project success.
Implement best practices for managing misconduct and fraud to protect patient safety and avoid costly regulatory and legal action.

BIOANALYTICAL SERVICES

Our state-of-the-art Bio Analytical facility at QCPL has been established to offer both standalone services & support clinical work undertaken in-house through.

Bio Analytical methods developed and validated using highly sophisticated instruments such as LC-MS/MS for estimation of analytes and/or metabolites in different biological matrices at the sensitivity range of µg/mL to pg/mL.

Our expertise in rapid method development and validation allows us to offer timely and cost-effective analysis of samples. The Bioanalytical facility is designed and equipped with world-class standards and procedures that align with SOPs, GLP and applicable regulatory. We adhere strictly to maintain QC measures, including thorough documentation and record-keeping at every stage of the process.

QUALITY ASSURANCE (QA):

The QA ensures strict compliance to GCP, GLP and other regulatory requirements.
QA ensures compliance by using validated systems and software’s in line with 21 CFR PART 11
Quality Assurance is responsible for ensuring that all projects are conducted in compliance with the study protocol, Operating Procedures and Regulatory & ethical guidelines.
The team is committed to ensuring strict compliance to regulatory standards and dedication to high quality, accurate results which in turn facilitate swift and successful approval of sponsor projects.

INDEPENDENT & STANDALONE SERVICES:

Besides Quantys integrated services, we also offer the following independent services such as:

Protocol design
Trial monitoring
Document archival
Post submission query support
Regulatory Dossier preparation
Sample size estimation and justification
PK modelling & analysis using WinNonLin
Report preparation in E3 and eCTD formats
Randomization & Statistical analysis using SAS
R&D services & contract manufacturing of clinical trial batches of various finished dosage formulations.