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

Global Regulatory & Clinical Writing Services

The Global Regulatory Medical Writing Unit at Pepgra delivers Clinical Study Protocols and Study Reports that are Scientifically accurate, Culturally Sensitive, fully Compliant with current regulations (ICH GCP guidelines), in a timely and Confidential manner.

Pepgra, a Clinical Research Organisation (CRO), understand the importance of regulatory Medical Writing in Clinical Research 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 of time and money. Further, delays and additional revisions can have significant cost implications. However, our qualified regulatory medical writing services help you in composing well-written regulatory documents and ensure that your clinical trial protocol is reviewed, edited and proofread properly that helps you save time and money. Pepgra regulatory medical writers work closely with your statistical, medical regulatory and data management team to deliver the meticulously accurate document to the highest ethical and scientific industry standards.

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Regulatory & Clinical research writing experts have the capabilities and skills to prepare regulatory submission documents required to seek US Food and Drug Administration (FDA) approval for drugs, devices and nutraceuticals (for health claims). The regulatory 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 regulatory medical writers hold vast experience in handling a wide range of therapeutic areas and all phases of development that are sound from both a scientific and regulatory perspective

 

Pepgra Extensive Experience

  • Full Dossier Development
  • Clinical Overview (eCTD Modules 2.5) including Literature Review
  • The Common Technical Document (CTD)
    • Module 2.3: Quality Overall Summary (QOS)
    • Module 2.4/2.6: Non-Clinical Overview / Summary
    • Module 2.5/2.7: Clinical Overview / Summary
    • Module 4 and Module 5
  • Module 3 – Quality
  • Regulatory eCTD dossier preparation, publishing and submission
  • Clinical Expert Statements
  • Briefing documents
  • Gap Analysis for Clinical part of the dossier
  • IND/NDA, MAA, PMA, 510(k) preparation and submission in US FDA, EMA Europe, Canada, Asia Pacific, Gulf countries and semi-regulated countries
  • Labeling and Core datasheet
  • Pharmacovigilance documents such as Periodic Safety Update Reports
  • Translation
  • For Medical Device: for Class, I (low risk), IIa, IIb, and III (high risk), Pepgra has extensive experience in preparing following reports:
    • (a) Clinical Evaluation Reports (CER) as part of the approval process allowing market access (CE-mark) for a medical device
    • (b) Clinical Data – Safety and/or performance of information generated from Clinical use of a device in question or a similar device for which equivalence has been demonstrated
    • (C) Equivalent Device Report – Similar technical, biological and clinical characteristics
    • (d) In-depth literature search and appraisal of relevant publications along with drafting of the CEO by our qualified experts
    • (e) Premarket, CE-mark studies, post-market studies and registries
    • For the Medical device, we are compliant with MEDDEV 2.7/1 Revision 4 guidelines to perform the clinical evaluation.
Regulatory writing

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.

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. Pepgra 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.

Pepgra Advantages to Ensure the Highest Quality

    Expertise and Experience:

  • Well-versed in working with various stakeholders like clinical operations, data management, biostatistics, medical and safety teams to deliver documents.
  • Experience in writing documents for various phases of clinical development including Phase I to Phase IV, post-marketing surveillance studies (PMS) and post-authorization safety studies (PASS)
  • Area of Regulatory Writing Experience include Medical Devices, Prescription Drugs (with extensive knowledge of pharmacokinetics, pharmacodynamics, pharmacogenomics), Over-the-counter Medicines, Veterinary medicines, Cosmetics, Biologics and Nutraceuticals
  • Complete understanding of the complex drug development process, including NCEs, generic, biologics and biosimilars
  • Knowledge of GPP3, ICMJE, CONSORT/STROBE /PRISMA (as appropriate) and other applicable regulatory guidelines. Besides, ICH, ABPI (Association of the British Pharmaceutical Industry), and FDA guidelines, STRAD Standards for Reporting of Diagnostic Accuracy, MedDev Guidelines (European Standards)

 

Pepgra Experts (Regulatory Medical Writers):

  • Our geographically and professionally broad team of regulatory writers are qualified to the MSc, M.D., M.B.B.S., Pharm.D. or Ph.D. level and possess extensive regulatory knowledge of industry guidelines located in 100+ countries.
  • Our regulatory medical writers have vast experience in writing and editing a wide range of clinical trial documentation involved in the regulatory process.
  • Our writers undergo regular training conducted by the AMWA (American Medical Writers Association) and the EMWA (European Medical Writers Association) and other recognized medical writing organization to keep their skills at the vanguard of the medical writing field.
  • Our translation team consists of native speakers with many years of experience in translating all documents necessary for the performance of clinical studies.
    Therapeutic Areas:

  • Vast experience in working across multiple therapeutic areas like Biochemistry, Diabetes, Gastrointestinal, Renal/Nephrology, Respiratory, Psychiatry, Rheumatology, Cardiovascular, Toxicology and Oncology
    • Editing & Formatting:

    • Submission-ready documents in terms of technical information, language, format, and template used to prepare the document
    • Our Quality Control & Assurance:

    • o All our clinical development services are done in accordance with our SOPs compliant standards. All our regulatory documents undergo thorough scientific, medical, editorial, quality check and assurance to ensure that the clinical documents we produce are scientifically accurate.
    • o The documents are prepared using sponsored-provided materials SOPs or pepgra suite of International Conference on Harmonization ICH-compliant templates and style guides. In either case, pepgra medical writing team ensures that the document we produce is of the highest quality in terms of scientific content, style and formatting.
    • Delivery:

    • Timely delivery of the highest standard of quality
    • Culturally sensitive to the locale and competitive price

At Pepgra

  • 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 ?

Pepgra 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 Pepgra?

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 Pepgra 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. Pepgra 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 Pepgra at Pepgra?

Yes, Pepgra 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. Pepgra 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 Pepgra?

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