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 […]

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Transparency and Disclosure_DEV

Study Participant Engagement, Transparency, and Disclosure Services Synchrogenix provides expertise, services, and technology, not only to meet transparency and disclosure requirements, but also as a complement to our commitment to enhance engagement of study participants and the general public in drug development. Synchrogenix produces anonymized and redacted datasets and clinical documents; authors Informed Consent Forms […]

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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 […]

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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 […]

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Technology and Innovation_DEV

Leading Edge Systems Synchrogenix develops interoperable and innovative technologies that support our services and differentiate ourselves in the market. Additionally, Synchrogenix provides strategy and delivery capabilities to implement emerging technology solutions both internally and externally. Synchrogenix offers the following solutions: Open APIs Microservices Data abstraction/anonymization User interface/data visualization solutions Cryptographic services Blockchain technology Artificial intelligence […]

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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 […]

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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 […]

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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 […]

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Topics:

Technology and Innovation

Leading Edge Systems Synchrogenix develops interoperable and innovative technologies that support our services and differentiate ourselves in the market. Additionally, Synchrogenix provides strategy and delivery capabilities to implement emerging technology solutions both internally and externally. Synchrogenix offers the following solutions: Open APIs Microservices Data abstraction/anonymization User interface/data visualization solutions Cryptographic services Blockchain technology Artificial intelligence […]

Read More
Topics:

Transparency and Disclosure

Study Participant Engagement, Transparency, and Disclosure Services Synchrogenix provides expertise, services, and technology, not only to meet transparency and disclosure requirements, but also as a complement to our commitment to enhance engagement of study participants and the general public in drug development. Synchrogenix produces anonymized and redacted datasets and clinical documents; authors Informed Consent Forms […]

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 […]

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Recent Advances in Development and Application of Physiologically-based Pharmacokinetic (PBPK) Models: A Transition from Academic Curiosity to Regulatory Acceptance

There is a renewed surge of interest in applications of physiologically-based pharmacokinetic (PBPK) models by the pharmaceutical industry and regulatory agencies. Developing PBPK models within a systems pharmacology context allows separation of the parameters pertaining to the animal or human body (the system) from that of the drug and the study design which is essential to develop […]

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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 […]

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