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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Certara’s Synchrogenix Division Collaborates with Hedera Hashgraph to Offer Data Flow and Transparent Collaboration Solutions for the Life Sciences Industry

October 15, 2018 – Certara today announced that it has formed a strategic collaboration with Hedera Hashgraph. Synchrogenix®, Certara’s regulatory sciences division, has been building distributed applications in the life sciences and healthcare markets that will expand its reach in the areas of transparency and disclosure, regulatory reporting and data sharing, and collaboration/communications from drug development through market access.

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Achieving Compliance with the FDA’s eCTD Mandate

Rob Labriola

The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs (INDs)—in the electronic Common Technical Document (eCTD) format. A DMF provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, […]

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Topics: Regulatory Submissions Management

6 Signs You Need Help with Submission Planning

Steve Sibley

Setting and adhering to a timeline for planning, drafting, reviewing, and editing regulatory documents needed for the submission dossier is a major challenge for drug development teams. I think of this process as having three phases: “discovery, drive, and survive.” In a previous blog post, I discussed the planning that occurs in the discovery phase. […]

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Topics: Regulatory & Medical Writing

Agreeing to Submission Document Timelines and Sticking to Them: Fairy Tale or Reality?

Steve Sibley

Does the thought of developing a submission for the marketing approval of a new drug fill you with dread? How do you avoid losing all of your holidays and weekends when developing a submission? Or burning out your team? In my career, I’ve helped teams develop robust submissions with minimal disruption to people’s lives and […]

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Topics: Regulatory & Medical Writing

Best Practices for a Successful eCTD Submission

Rob Connelly

The eCTD struggle is real. Regulatory submissions must conform to the electronic common technical document (eCTD) format to be successfully received and reviewed by health authorities. And while this might seem simple, this complex technical process is actually rife with risk if you lack expertise in medical writing and regulatory publishing. In this blog post, […]

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Topics: Regulatory Submissions Management

Things About eCTD You May Not Have Known

Rob Connelly

In helping clients with their regulatory operations and electronic publishing needs, I’m often asked about preparing regulatory submissions in the electronic common technical document (eCTD) format. While a lot of us have been working in the eCTD format for many years, new start-up companies focusing on rare diseases and new technologies to treat patients are […]

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Topics: Regulatory & Medical Writing, Regulatory Submissions Management

Best Practices for Writing Clinical Study Protocols

Kelley Kendle

The pharmaceutical industry has long grappled with the problem of poorly written clinical study protocols. The study protocol describes the conduct of a study, its objectives, methodology, design, and statistical considerations and ensures the safety of participants and integrity of data collected. The teams generally responsible for protocol writing are the medical writing and regulatory […]

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Topics: Clinical Transparency & Disclosure, Regulatory & Medical Writing

Avoiding Pitfalls in Plain Language Summaries of Clinical Trial Results

Behtash Bahador

Building trust with clinical trial participants is critical to the success of drug development programs. One of the best ways to earn that trust is by meeting their expectations regarding learning study results. In fact, a 2015 study by the Center for Information and Study of Clinical Research Participation (CISCRP) showed that 73% of clinical […]

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Topics: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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