Regulatory and Medical Writing Services

Regulatory and Medical Writing Services_DEV

Strategic Writing and Compliance is Key to Successful Drug Development High quality medical and regulatory writing is an essential part of any successful drug development program. Pharmaceutical and biotech companies need a trusted, agile, and experienced partner not only to write medical documents, but also to be a strategic partner and address key issues. Synchrogenix […]

Read More
Topics:

Communications

Strategic Writing and Compliance is Key to Successful Drug Development High quality medical and regulatory writing is an essential part of any successful drug development program. Sponsors need a trusted, agile, and experienced partner not only to write these documents, but also to provide program guidance to address key issues and opportunities. Synchrogenix has developed […]

Read More
Topics:

Operations_DEV

Synchrogenix Regulatory Submission and Publishing Services The skills needed to confidently compile an electronic regulatory submission take years of on-the-job training, industry immersion, and regulatory study to develop. Full or partial outsourcing to a proven electronic common technical document (eCTD) partner is often the most cost effective solution, and one that gives your organization the […]

Read More
Topics:

Consulting_DEV

Synchrogenix Provides Global Regulatory Strategy Consulting, Harnessing All of Certara’s Capabilities and Leveraging Our Technologies and Domain Expertise Regulatory gap analysis of development programs and global dossiers to increase probability of success for approval and patient access Agency engagement preparation, communications, and leadership Review of Agency correspondence, analysis of relevant regulatory guidelines and precedent Competitor […]

Read More
Topics:

About Certara

Changing the Game in Drug Development and Patient Access At Certara, we are innovators, dedicated to helping our clients develop new therapies and target unmet medical needs, expand existing therapies to other subpopulations, communicate scientific information in the language of regulatory success and market access, balance risk-benefit profiles, differentiate therapies from the competitive landscape, and […]

Read More
Topics:

Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions

Maria Saluta

Analogous to how a geologist surveys the “lay of the land” to determine if oil lies underneath, or an investment advisor strives to understand the “lay of the land” to decide how to invest in a turbulent market, sponsors and regulators also need to determine how to best utilize and report modeling and simulation results […]

Read More
Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Regulatory Submissions Management

Clinical Pharmacology Gap Analysis

Increase your Odds of Regulatory Success with a Quantitative and Regulatory Science-based Strategy As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in performing a strategic assessment is a gap analysis and […]

Read More
Topics:

Drug Development and Clinical Pharmacology Strategy

Strategic Drug Development Involves Thinking Without Borders™ Certara has demonstrated that a modern, state-of-the-art integrated drug development approach, using quantitative methods to inform, guide, and supplant traditional development methods, will dramatically improve efficiency and reduce costs. Creating unquestionable value for our clients is our objective. To achieve these objectives, Certara employs a strategic and programmatic […]

Read More
Topics:

Operations

Synchrogenix Regulatory Submission and Publishing Services The skills needed to confidently compile an electronic regulatory submission take years of on-the-job training, industry immersion, and regulatory study to develop. Full or partial outsourcing to a proven electronic common technical document (eCTD) partner is often the most cost effective solution, and one that gives your organization the […]

Read More
Topics:

Regulatory Consulting

Synchrogenix Provides Global Regulatory Strategy Consulting, Harnessing All of Certara’s Capabilities and Leveraging Our Technologies and Domain Expertise Regulatory gap analysis of development programs and global dossiers to increase probability of success for approval and patient access Agency engagement preparation, communications, and leadership Review of Agency correspondence, analysis of relevant regulatory guidelines and precedent Competitor […]

Read More
Topics:

Regulatory and Medical Writing Services

Strategic Writing and Compliance is Key to Successful Drug Development High quality medical and regulatory writing is an essential part of any successful drug development program. Pharmaceutical and biotech companies need a trusted, agile, and experienced partner not only to write medical documents, but also to be a strategic partner and address key issues. Synchrogenix […]

Read More
Topics:

PK/PD Drug and Disease Modeling and Simulation

Quantifying Drug, Disease, and Trial Information to Aid Efficient Drug Development For almost 20 years, our pharmacometricians have combined insight and innovation to build quantitative models of the interactions between the human body, drug effects, and diseases. Our team develops models that are fit-for-purpose and meet strategic objectives, are aligned with regulatory authority requirements and […]

Read More
Topics:

About Our Consulting Services

Why Partner with our Drug Development, Regulatory, and Clinical Pharmacology Experts? Committed to scientific, regulatory, and commercial advancement, Certara creates impactful solutions facing the biopharm industry today—speed and cost. The largest and most comprehensive provider of strategic drug development, modeling and simulation, and regulatory science services, Certara partners with you to optimize drug development and […]

Read More
Topics:

About Certara

Changing the Game in Drug Development and Patient Access At Certara, we are innovators, dedicated to helping our clients develop new therapies and target unmet medical needs, expand existing therapies to other subpopulations, communicate scientific information in the language of regulatory success and market access, balance risk-benefit profiles, differentiate therapies from the competitive landscape, and […]

Read More
Topics:
Learn More LinkedIn Twitter Facebook Email Subscribe to the Blog