Nonclinical & Clinical Pharmacology Support for IND/IMPD and NDA Modules
Our Regulatory & Medical Writing services encompass the meticulous preparation of nonclinical and clinical pharmacology documentation required for Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), and New Drug Application (NDA) submissions. Our team of experienced writers and regulatory experts collaborate closely with clients to deliver high-quality, scientifically sound documents that adhere to regulatory guidelines and standards.
Overview
We provide end-to-end support for the preparation of regulatory documents related to nonclinical and clinical pharmacology, including study reports, summaries, and overviews. Our services cover all aspects of IND, IMPD, and NDA modules, ensuring comprehensive documentation for regulatory submission.
The Vital Role of Regulatory Documentation in Drug Approval
Regulatory documents play a crucial role in the drug approval process, providing essential information on the safety, efficacy, and quality of the investigational product. Properly prepared documentation is required to demonstrate compliance with regulatory requirements and facilitate successful approval by regulatory authorities.
Key Features
- Expert team of regulatory writers and medical professionals.
- Compliance with regulatory guidelines and standards.
- Scientifically rigorous and comprehensive documentation.
- Tailored solutions to meet specific regulatory requirements.
How it works
Regulatory Query Response Process
Consultation
Initial consultation to understand your specific regulatory writing needs.
Document Preparation
Collaborative development of regulatory documents based on provided data and requirements.
Review and Revision
Iterative review process to incorporate feedback and ensure accuracy.
Finalization and Submission
Finalization of documents and support for submission to regulatory authorities.
Years of Experience
Our vision is to empower health by envisioning a world where innovative medicines foster well-being and resilience, transforming lives.
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
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.
Patient-Centric Approach
We prioritize patient needs, ensuring that drug development aligns with real-world clinical practice. Patient perspectives guide our work.
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.
Frequently Asked Question?
Comprehensive Answers to Your Inquiries about Biopharmetrics’ Services
How can Biopharmetrics' Regulatory & Medical Writing Services benefit my drug development process?
Our Regulatory & Medical Writing Services are designed to streamline the preparation of regulatory documents required for drug approval, particularly focusing on nonclinical and clinical pharmacology support for Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), and New Drug Application (NDA) submissions. By leveraging our expert team of regulatory writers and medical professionals, we ensure meticulous preparation of scientifically sound documents that adhere to regulatory guidelines and standards. This support not only facilitates compliance but also enhances the efficiency of your drug development process, ultimately aiding in successful approval by regulatory authorities.
How does Biopharmetrics ensure the accuracy of drug behavior predictions?
At Biopharmetrics, we pride ourselves on our comprehensive approach to regulatory and medical writing. Our services cover all aspects of IND, IMPD, and NDA modules, offering end-to-end support for the preparation of regulatory documents related to nonclinical and clinical pharmacology. We prioritize scientific rigor, ensuring that our documentation is not only compliant but also scientifically robust. Additionally, our tailored solutions are designed to meet specific regulatory requirements, providing personalized support to each client. With our collaborative process and iterative review system, we strive to deliver high-quality documents that stand out for their accuracy and clarity.
How does Biopharmetrics' Regulatory & Medical Writing Services ensure the success of regulatory submissions?
Our Regulatory & Medical Writing Services play a vital role in facilitating the success of regulatory submissions by providing expert guidance and support throughout the process. From the initial consultation to the finalization and submission of documents, our team works closely with clients to understand their specific needs and requirements. We employ a meticulous document preparation process, which includes collaborative development, iterative review, and incorporation of feedback to ensure accuracy and completeness. By adhering to regulatory guidelines and standards, our services help demonstrate compliance and enhance the quality of submissions, ultimately increasing the likelihood of successful approval by regulatory authorities.
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
