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IND:+91 8754446690
US:+1-972-502-9262
UK:+44-1143520021

Regulatory Writing

Medical Writing Experts team consists of primarily Ph.D. level Research scientists with excellent communication skills, and trained International Society for Medical Publication Professionals(ISMPP) or American Association of Medical Writers (AMWA)

We understand the importance of a clinical trial that is written in a clear and precise manner which is easily understood by IRB, FDA, and any other reviewers. It is risky to submit a poorly written protocol which leads to a huge loss in time and money. Further, delays and additional revisions can have significant cost implications. However, our qualified regulatory medical writing services helps you in composing a well-written clinical trial and ensures that your clinical trial protocol is reviewed, edited and proofread properly that helps you save time and money and importantly the reputation of you/your organization.

 

Our team has the capabilities and skills to prepare regulatory submission documents required to seek US Food and Drug Administration (FDA) approval for drugs and devices. The Medical Writing Solutions we offer include regulatory compliance solutions in preparing essential documents for clinical trial submissions such as investigator brochures (IBs), protocols, common technical documents (CTDs), eCTD modules, periodic safety update reports (PSURs), development safety update reports (DSURs), annual safety reports (ASRs), clinical study reports (CSRs), documents related to pharmacovigilance like risk management plans (RMPs), periodic safety update reports (PSURs) and other associated documents. Our experts hold vast experience in handling several therapeutic areas including immunology and vaccines.

How we can help

 

  • Our medical writers can prepare a wide range of documents involved in the regulatory process. All our regulatory writing is done in accordance with our SOPs compliant standards.
  • We scrutinize the content of our medical writers and ensure that the documents we produce are scientifically accurate. When writing clinical study reports using data supplied to us we have often uncovered problems with the data or analyses that would have been costly to the entire research: for example, inappropriately calculated statistical hypothesis tests that could have led to the wrong conclusions had they not been corrected.
Regulatory writing

Write and develop a wide range of regulatory writing documents and other clinical research documentation for any phase of clinical development (Phase I through Phase III)

Protocols

Our team of medical writers has considerable experience writing clinical study reports and protocols. We ensure that we provide the best of services to our client and in turn ensure the following.

Brochure

Investigator Brochure characterizes the investigational material(new drug, biologic, or medical device)regarding its physical properties and will contain information from some or all the disciplines:pharmacology,toxicology,and pharmacokinetics/pharmacodynamics.

Brochure

Consent forms

Millions of volunteers participate in government- and industry-sponsored clinical trials each year. Prior to agreeing to participate, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent and it is a process that can help you decide whether or not participating in a trial is right for you.

Study Reports

We are experts in writing, editing, or managing reviews of final study reports, serious adverse event narratives, manuscripts, and NDA and IND submissions. Our consultants, including CRAs, medical writers, and contract negotiators, have extensive clinical research experience.

Safety Narratives

Guidelines issued by regulatory agencies and the international organizations define rigorous responsibilities for safety assessment and reporting in clinical studies, including narrative statements on special categories of adverse events for individual subjects.

Data Summaries

We delivers all-inclusive data management services utilizing efficient yet meticulous processes coupled with advanced technologies. We design, build, and deploy clinical databases faster than the industry norm; and our highly experienced team of data management professionals, manages your clinical trial data with keen precision and accuracy.

Surveillance Plan

The need for safety surveillance studies stems from inherent limitations in the clinical trial process used for regulatory approval. Medical Writing Experts has experienced clinical and medical data professionals who can develop an effective pharmacovigilance program.

Report Forms

CRF (case report form) is an official clinical data recording document or tool used in a clinical study. A properly designed CRF saves time and money, can be reused and is critical to the accuracy and completeness of the data. CRF collects all relevant data in the required specific formats by the protocol compliance requirements of regulatory agencies.

At Medical Writing Experts

  • Write and develop a wide range of regulatory writing documents and other clinical research documentation for any phase of clinical development (Phase I through Phase III)
  • Collaborate and coordinate with large cross-functional teams of clinical research expert.
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What Our Customers Are Saying ?

FAQs

What are the different types of Regulatory and clinical writing services you offer ?

Medical Writing Experts offers the various types of clinical and regulatory writing such as Clinical study reports and protocols, Investigation brochure (New drug, biologic, or medical device), Informed Consent Document, Clinical Study Reports, plan I to III study report, Non-Clinical Study Reports, Non-Clinical Summaries and Overviews, safety narratives, all-inclusive data management, Periodic Safety Update Reports, Safety Surveillance Plan and case report form.

What Skill does a qualified Medical writer bring at Medical Writing Experts?

Our qualified medical writers are good in writing the different types of scientific documents such as regulatory and clinical writing, research-related and drug/disease related documents, publication support services, manuscript editing services and scientific publication support.
Our Medical Writing Experts team possesses the following skill that helpful in the area of clinical and regulatory medical writing.
• Thoroughly scrutinize documents requirement.
• They provide comprehensive knowledge of the regulations such as European, US, and international pharmaceutical. (If any)
• Analyses and visualize the output that demonstrates the outcomes of a study.
• They build a clear and consistent documents complaints along with the regulation requirements or appropriate authorities inquiries
• Regulate and coordinate the essential inputs from the clinical team
• Stage-manage an effective and disciplinary Document review process
Produce the template documents that exactly replicate the complete study information or data and meanwhile; it meets the required international standards.

I want the therapeutic expertise to support my clinical studies. Do you offer?

Yes. We offer all-inclusive therapeutic expertise across a wide variety of indications. Medical Writing Experts shapes its clinical trials services to meet your requirements. We can provide complete program development, delivery services for any part of a trial that you are looking to outsource or even save failing trials. With our experienced clinical research, medical and scientific professionals, we have an in-depth knowledge that allows us to apply new concepts and innovation into clinical trials.

Could I outsource all Medical Writing Experts at Medical Writing Experts?

Yes, Medical Writing Experts Main Motto is to work hands-on with our clients to give 100% satisfaction based on their requirements. From start to end, you can be sure of proactive coordination of our experts. Our Medical teams have the capability to handle any regulatory and clinical documentation.

I want the therapeutic expertise to support my clinical studies. Do you offer?

Yes. We offer all-inclusive therapeutic expertise across a wide variety of indications. Medical Writing Experts shapes its clinical trials services to meet your requirements. We can provide complete program development, delivery services for any part of a trial that you are looking to outsource or even save failing trials. With our experienced clinical research, medical and scientific professionals, we have an in-depth knowledge that allows us to apply new concepts and innovation into clinical trials.

Having more questions regarding our writers, pricing or any at Medical Writing Experts?

Let’s connect us through our quick contact form to get an instant call back.
Connect us at
India No: +91-8754446690
Email: info@medicalwritingexperts.com
Website: http://www.medicalwritingexperts.com/