Our Services
Precision Solutions for Drug Development
At Biopharmetrics, we offer a comprehensive suite of services meticulously crafted to navigate the complexities of drug development. From pharmacokinetic modeling to regulatory strategy, our expert team provides tailored solutions that streamline processes, enhance efficiency, and ultimately accelerate the journey from concept to market.
With a commitment to innovation and patient-centricity, we empower pharmaceutical companies to bring life-changing medicines to patients worldwide, driving progress and improving healthcare outcomes.
What we offer
Dedicated to Your Health and Happiness
In Vitro-In
Vivo Correlation
Biopharm Design
Input
Biorelevant Specifications
Pharmacokinetic/ Pharmacodynamic
In Vitro-In
Vivo Correlation
Biopharm Design
Input
Biorelevant Specifications
Pharmacokinetic/ Pharmacodynamic
PBPK Modelling/
PBBM Modelling
Regulatory Query Response Support
Regulatory & Medical Writing
Statistical Analysis and Report submission
PBPK Modelling/
PBBM Modelling
Regulatory Query Response Support
Regulatory & Medical Writing
Statistical Analysis and Report submission
Why Choose Us
In the realm of drug development, Biopharmetrics stands out for several reasons
In-House Bio-Pharm Expertise
We act as an in-house bio-pharm expert for the organizations and provide support to them at any time
Clinical Trial Optimization
We design and optimize clinical trials, ensuring efficient data collection and robust evidence generation. Our expertise streamlines the drug development process.
Regulatory Strategy
We navigate complex regulatory landscapes, providing strategic guidance to meet requirements. Our insights facilitate successful submissions and approvals.
Scientific Communication
Our team communicates research findings effectively, bridging gaps between stakeholders. Clear, evidence-based communication drives informed decisions.
Nimble Project Management
An expert bio-pharma consultant would be the SPOC for all the communications related to the project
Pharmacometric Modeling
Leveraging advanced modelling techniques, we quantify drug effects, predict outcomes, and optimize dosing regimens. This informs decision-making and enhances patient safety.
Risk Assessment
We assess risks associated with drug development, identifying potential pitfalls early. This proactive approach minimizes setbacks and accelerates progress.
Patient-Centric Approach
We prioritize patient needs, ensuring that drug development aligns with real-world clinical practice. Patient perspectives guide our work.
Our Approach
Integrated Approach to Quality-Centric Drug Development
Our methodology integrates systematic and quantitative techniques, emphasizing clinical relevance, to ensure optimal product quality control and enhance patient outcomes.
Multivariate Models
Utilizing multivariate models to link raw material attributes, providing insights into their impact on product dissolution.
In Vitro/In Vivo Correlation (IVIVC)
Establishing connections between in vitro and in vivo data, ensuring clinical relevance in drug development.
Predicting Exposure Ratios
Utilizing models to predict exposure ratios between future and clinical batches, defining limits for consistency.
Raw Material Quality Control
Setting clinically meaningful limits for raw material quality control to ensure bioequivalence with clinical batches.
Optimizing Drug Product Quality
Applying mechanistic understanding through PBBM to optimize drug product quality attributes for enhanced safety and efficacy.
Application of PK/PD Modelling
Developing PK/PD models to address hypothetical scenarios, providing solutions for informed decision-making
Frequently Asked Question?
Comprehensive Answers to Your Inquiries about Biopharmetrics’ Services
What services does Biopharmetrics offer?
Biopharmetrics offers a comprehensive range of services to support drug development, including pharmacokinetic/pharmacodynamic (PK/PD) modeling, in vitro-in vivo correlation (IVIVC), biopharm design input, biorelevant specifications, PBPK/PBBM modeling, regulatory query response support, regulatory and medical writing, and statistical analysis and report submission.
How does Biopharmetrics ensure the accuracy of drug behavior predictions?
Biopharmetrics utilizes advanced modeling techniques, such as PBPK and PK/PD modeling, to bridge laboratory data with real-world drug behavior. This ensures precise predictions, optimizing dosing regimens, and enhancing patient safety and drug efficacy.
What is the significance of In Vitro-In Vivo Correlation (IVIVC) in drug development?
IVIVC is crucial as it connects laboratory data with clinical outcomes, providing insights into drug behavior. This empirical and mechanistic understanding helps in making informed decisions during drug development, ultimately ensuring that the drug behaves as expected in real-life scenarios.
How does Biopharmetrics support regulatory submissions?
Biopharmetrics offers extensive regulatory support, including responding to regulatory queries, providing strategic guidance, and preparing regulatory and medical writing for submissions. Their expertise ensures compliance and facilitates successful IND/IMPD and NDA submissions with robust evidence.
What makes Biopharmetrics different from other pharmaceutical consulting services?
Biopharmetrics stands out due to its integrated, patient-centric approach to drug development. They combine in-house bio-pharm expertise, advanced modeling techniques, and a commitment to innovation. Their focus on clinical relevance, risk assessment, and efficient project management ensures optimal outcomes for drug development projects.
Testimonials
Discover What Our Clients Have to Say
We had an outstanding experience working with Biopharmetrics. Their deep expertise in PBPK Modelling & Simulation was evident from the start of the mAb project. The Clinical Pharmacology consultancy support in clarifying queries from the Regulatory Agency and Principal Investigator of our upcoming trial was helpful. The team’s dedication to our project, attention to detail and strict adherence to our timelines helped us achieve our goals ahead of schedule. They worked closely as part of the regular project team and took utmost care in proposing any solutions. We appreciate their commitment and highly recommend Biopharmetrics for anyone seeking PBPK Services." - Battery Bio at Vial
We engaged Biopharmetrics for IVIVC services for our products and continue to work with them, they have been very proactive in proposing solutions like optimizing the dissolution profile, selecting bio-relevant dissolution media based on pilot bio results and shortlisting the pilot batches for pivotal BE studies. Their experience in using mathematical modelling tools ie IVIVC and PBPK for predictions has helped us immensely. They have been an integral part of R&D projects, working closely with CFT’s and aligning the deliverables as per our timelines. We recommend Biopharmetrics to others who are experiencing challenges in their formulation R&D
Case Studies
Optimizing Preclinical PBPK Models for Human Application
Dive into our case study to discover how we refine preclinical PBPK models, bridging the gap between animal studies and human application for precise exposure predictions and dosage regimen optimization.
Oxcarbazepine ER Suspension: Development of In Vitro Dissolution Profile
Explore the development of in vitro dissolution profiles for Oxcarbazepine ER Suspension in our case study.
Predicting In Vitro Dissolution of Extended Release Drugs from In Vivo Profiles
Explore our case study on accurately predicting in vitro dissolution of extended-release drugs from in vivo profiles.
Preclinical PBPK Model Translated for Human Exposure Prediction
Unlock insights into translating preclinical PBPK models for accurate human exposure predictions.
Blogs
Innovative Insights in Drug Development
Explore the Latest Trends, Research, and Case Studies in Pharmaceutical Consulting with Biopharmetrics
