PharmaPRO's expert team of pharmacometricians build models tailored to guide your drug development program’s decisions
PharmaPRO offers a full repertoire of functional expertise, as you take your product from discovery to market.
PharmaPRO's consultants have experience authoring a diverse array of documents for submission to the FDA and other regulatory agencies.
PharmaPRO's team of regulatory affairs professionals understand the statutes, key regulatory opinions, and procedures that make for successful interactions with regulatory authorities like the FDA.
In the study design phase, PharmaPRO works with your team to craft well-designed studies that contribute to your drug development plan.
PharmaPRO is unique in that we have implemented and developed a specialized Data Management and Programming team, specifically in compliance with CDISC standards.
Drug development continues to be time consuming, expensive, and inefficient, while pharmacotherapy is often practiced at a suboptimal level of performance. This trend has not waned despite the fact that vast amounts of data are obtained during clinical trials and patient care each year.
Within these data, knowledge that would improve drug development and pharmacotherapy lays hidden and undiscovered. With the publication of the Guidance for Industry: Population Pharmacokinetics by the Food and Drug Administration (FDA), and recently the FDA Critical Path Initiative: The Critical Path to New Medical Products, the assimilation of pharmacometrics as an applied science in drug development and evaluation is increasing.
Pharmacometrics is the science of quantitative clinical pharmacology that impacts decision making throughout the drug development and regulatory review process. It is based primarily on pharmacokinetic and pharmacodynamic modeling and simulation with applications including, among others, clinical trial design and dose optimization. Through the channel of quantitative drug, disease, and trial models, pharmacometric methods have the unique ability to leverage all prior and current information from diverse sources, including pathophysiology, clinical pharmacology, and statistics.
Our Pharmacometrics staff is a multidisciplinary team consisting of quantitative clinical pharmacologists, statisticians, engineers, and data management experts who work closely with clinicians and statisticians.
We can help you author the clinical pharmacology sections for submission to various health authorities (FDA, PMDA, SFDA, EMA, KFDA, etc) which include:
o eCTDs modules 2.7.1 and 2.7.2
o Question-based Reviews (QbR)
o Clinical Study Protocols
o Clinical Study Reports
o Investigational New Drug (IND) Applications
o New Drug Applications (NDA)
o Pediatric Investigation Plans (PIP)
o Pediatric Study Plans (PSP)
o Orphan Drug Designation Applications (ODD)
o Breakthrough Therapy Designations Applications
Our seasoned professionals can address questions relating to Clinical pharmacology, PK, PK/PD, and POPPK from various regulatory agencies across the world.
We can help you develop strategy and execute clinical pharmacology plans, PIP Binding elements, and PSP plans. PharmaPro does this by serving as clinical pharmacology project leader and providing scientific leadership on Biologics, ADCs and combination therapies, in oncology, immuno-oncology, diseases with unmet medical needs, etc.
We can participate in due-diligence and in-licensing activities, conduct market research analyses, and forecast trends. Based on project needs, we can conduct hands-on PK, PK/PD analyses, provide QC-QR of IBs, CSRs, and create health authority submission documents.
An efficient drug development process and rapid review and approval are the goals of every pharmaceutical sponsor, but numerous factors make this goal difficult and sometimes impossible to achieve. Although some of these factors are beyond the control of the sponsor, many delays in the regulatory process can be avoided by conceiving a robust regulatory strategy early in the development process. When a regulatory strategy document is prepared prior to development planning and updated throughout the development process, it provides the project team with a valuable reference resource and guideline, enabling them to make informed decisions in line with FDA requirements. This will ultimately reduce avoidable delays in the development, review, and approval processes and allow for the marketing of important new drugs.
We have demonstrated with many of our clients that a modern, state-of-the-art integrated drug development approach, using quantitative methods to inform, guide, and supplant traditional development methods, dramatically improves efficiency and reduces costs. Our team of experts work as an integrated part of your team, asking and answering questions, leveraging the most innovative modeling and simulation technologies and providing deep scientific and regulatory acumen to impact the Return of Investment of the clients R&D investment.
Chemistry, Manufacturing, and Controls Regulatory Affairs (CMC RA) maintains a central role in the development, licensing, manufacture, and marketing of pharmaceutical products. As part of this vital role, experienced CMC RA professionals assist in ensuring pharmaceutical products maintain consistent levels of effectiveness, safety, and quality for consumers. Expansions in technical experiences and scientific knowledge have led to advanced biopharmaceutical manufacturing processes and products. This increased complexity has resulted in a growing and evolving array of regulatory agency expectations related to CMC activities. It is essential that sponsor companies fully comprehend regulatory compliance requirements for their specific type of pharmaceutical product, and they devote sufficient resources needed to meet these requirements. Overall, CMC RA plays a pivotal role in the development, licensure, manufacturing, and ongoing marketing of pharmaceutical products. In this role, CMC RA professionals help ensure that pharmaceutical products are consistently effective, safe, and provide high quality for consumers
We have a team of CMC professionals who have experience in both authoring and submitting. Our team members have many years of experience in submitting, as these individuals are responsible for preparing scientific responses to regulatory agency queries, which is significant in determining whether the drug is approved.
Medical writing involves writing scientific documents of different types which include regulatory and research-related documents, disease or drug-related educational and promotional literature, publication articles such as journal manuscripts and abstracts, and content for healthcare websites, health-related magazines, or news articles. The scientific information in these documents needs to be presented to suit the level of understanding of the target audience, namely, patients or general public, physicians, or the regulators. Medical writers require an understanding of the medical field and terminology, knowledge of relevant guidelines as regards the structure and contents of specific documents, and good writing skills. They also need to be familiar with searching medical literature, understanding and presenting research data, the document review process, as well as editing and publishing requirements.
We provide world-class medical writing expertise across a broad range of therapeutic areas and document types, from preclinical reporting through the drug development life cycle to post-marketing and commercialization writing.
Our writers develop documents from data sources in various analytic models for a variety of audiences, manage writing projects, and maintain consistency of style and message across multiple documents. They possess strong project management and negotiation skills and support projects with multiple customer contributors and external thought leaders. They drive timelines, organize and lead authoring meetings, and reconcile sponsor feedback across functions to create consistent, scientifically cohesive documents while minimizing nonessential customer oversight.
PharmaPro Consulting’s expert biostatisticians with wide industry experience will help you apply solid statistical and scientific principles to select the optimal study design, randomization, endpoints, sample size, and analyses to accelerate the clinical development program for your compounds.
Our consultancy services include:
o Independent verification of study design, sample size, and endpoints
o Independent review of analysis plans and validate the sufficiency of analysis
o Perform sensitivity analyses to test the robustness of results
o Assist in regulatory strategy planning, regulatory questions, and meetings
o Our programming expertise will enable you to transform your analysis needs to modular code that arrives at the right results quickly and consistently with high traceability.
In addition, we can consult on the following services:
o Regulatory compliance evaluation of clinical trial data
o Verification of adherence to industry data standards (CDISC SDTM/ADaM, SEND)
o Verification of M5 data submission package
o Optimizing programming process in existing teams/environment
o Data Standards Gap Analysis
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