Medical Writing Services in USA, India & Europe

Whether done as part of a clinical trial or as a stand-alone project, the professional medical writers at ProRelix Research combine medicine, science, and technical writing to deliver concise documents for all stages of regulatory, project management, and final reports.

With the unique blend of medical writers comprising of doctors, pharmacists, scientists and grammar experts, ProRelix provides medical writing services from essential documents such as study synopsis and protocol, clinical study report (CSR), investigator’s brochure (IB) informed consent form (ICF), case report form (CRF), etc. ProRelix has a devoted team of subject experts for abstract writing, manuscript writing, journal articles, and submissions. We provide these medical writing and publication services in India, USA, Europe, UK

We feature Medical Writing Services in India, catering to local and regional needs with a deep understanding of the Indian regulatory landscape. Similarly, our Medical Writing Services in the USA are designed to meet global standards, addressing the specific requirements of U.S. based clients with precision and expertise. 
As part of our medical writing consulting services, we provide specialized strategies for pharmaceutical companies and other stakeholders, ensuring compliance and high-quality deliverables. Our medical writing services list includes: 
 
  • Protocol Development
  • Clinical Study Reports (CSR)
  • Investigator’s Brochures (IB)
  • Informed Consent Forms (ICF)
  • Case Report Forms (CRF)
  • Manuscripts and Abstracts
  • Journal Submissions 
 
Recognized for delivering the best medical writing services, ProRelix Research stands out for its ability to combine technical expertise and regulatory knowledge. Whether it’s medical writing for pharmaceutical companies or extensive documentation support, we ensure excellence in every aspect. 
 
Let ProRelix Research be your trusted partner for medical writing, whether you’re in India, the USA, or beyond. 

Clinical Research Writing

  • Study Synopsis & Protocol

  • Clinical Study Report (CSR)

  • Investigator’s Brochure (IB)

  • Informed Consent Form (ICF)

  • Case Report Form (CRF)

  • Quick Design And Layout

  • Direction High Level Idea

  • And Concept Illustration

Regulatory & Pharmacovigilance

  • Clinical sections of common technical documents (CTDs) & new drug applications (NDAs)

  • Risk Management Plans (RMP)

  • Periodic safety update report (PSUR)

  • Benefit risk evaluation report

  • Patient safety summaries/ narratives

  • Summary product characteristics (SPC)

  • Package Inserts

Publication

  • Abstracts writing

  • Manuscript writing

  • Journal articles & submission

ProRelix Research has undertaken a wide range of medical writing assignments such as:

  • Protocols

  • Clinical Study Reports

  • Literature Research

  • Technical Document

  • Case Narratives

  • Abstracts and Manuscripts

  • Documentation for congress exhibits (abstracts, posters, and slide presentations)

  • Investigator’s Brochures (IBs)

  • Investigational Medicinal Product Dossiers (IMPDs)

  • Investigational New Drug documents (INDs)

  • Pediatric Investigation Plans (PIPs)

  • Risk Management Plans (RMPs)

  • Common Technical Document (CTD/eCTD)

Delivering Scientific Clarity and Regulatory Precision Across the Clinical Development Lifecycle

At our organization, we understand that medical writing is not merely a support function—it’s a critical scientific discipline that transforms complex data into actionable insight. In today’s dynamic regulatory landscape, success in clinical development hinges on clear, accurate, and compliant documentation. Our medical writing services are designed to seamlessly integrate with your clinical and regulatory strategies, ensuring that every word we write propels your product forward in a scientifically robust and globally compliant manner.

As an end-to-end clinical research organization, we offer a full spectrum of medical writing services that span early-phase research to post-marketing submissions. Our seasoned team of medical writers brings together advanced scientific training, therapeutic expertise, and a deep understanding of international regulatory requirements. Working in close collaboration with cross-functional teams—including clinical operations, pharmacovigilance, regulatory affairs, and biostatistics—we ensure that our documentation reflects the highest standards of scientific accuracy, regulatory rigor, and editorial excellence.

Delivering Scientific Clarity and Regulatory Precision Across the Clinical Development Lifecycle

Regulatory Medical Writing

Our approach to medical writing is both strategic and adaptive. Whether you’re developing a novel biologic, repurposing an established molecule, or advancing an innovative medical device, our team tailors its documentation strategy to your unique objectives, timelines, and regulatory targets. Our services encompass the full lifecycle of clinical and regulatory documentation, including a strong focus on regulatory medical writing, ensuring alignment with global standards and expectations.

Comprehensive Medical Writing Solutions Across Clinical Phases

  • Clinical Trial Protocols: We specialize in developing scientifically sound, regulatory-compliant clinical trial protocols that are both operationally feasible and aligned with ICH E6(R2) GCP standards. Our protocol development support services clearly articulate study design, objectives, methodology, endpoints, and statistical considerations, ensuring that all stakeholders—from investigators to regulators—are aligned.

  • Investigator’s Brochures (IBs): The IB is a cornerstone document for regulatory submissions and clinical site training. Our writers synthesize preclinical and clinical data into a coherent, scientifically rigorous document through our specialized investigator’s brochure writing services that communicate the investigational product’s safety profile, mechanism of action, and rationale for ongoing study.

  • Informed Consent Forms (ICFs): Patient-centricity is central to ethical clinical research. Our team develops informed consent forms that are not only compliant with regional ethics standards but also easy to understand, ensuring that patients can make informed decisions about their participation.

  • Clinical Study Reports (CSRs): Our writers are adept at preparing ICH E3-compliant clinical study reports. Our clinical study report (CSR) preparation services detail the methods, conduct, results, and interpretation of clinical trials. We collaborate with biostatisticians to ensure accurate representation of statistical analyses and key efficacy and safety outcomes.

  • Regulatory Submission Documents: We have deep experience preparing documentation required for IND, NDA, CTA, and MAA filings. Our offerings include summaries of clinical efficacy (SCE), summaries of clinical safety (SCS), integrated summaries (ISS/ISE), and full Common Technical Document (CTD) preparation in alignment with global submission requirements. We also support response-to-queries packages for regulatory agencies including the FDA, EMA, CDSCO, TGA, and others.

  • Scientific Publications and Medical Communications: Beyond regulatory writing, our medical communication specialists craft high-impact manuscripts, abstracts, posters, and slide decks for scientific congresses and peer-reviewed journals. Through our manuscript writing and publication support services, every publication is developed in accordance with GPP (Good Publication Practices) and ICMJE authorship guidelines, ensuring transparency, credibility, and alignment with sponsor messaging.
  • Risk Management and Safety Documents: Our pharmacovigilance writers are proficient in preparing Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and other safety narratives critical to product lifecycle management.

 

Therapeutic Expertise that Drives Targeted Scientific Messaging: One of the distinguishing strengths of this expert team is its deep therapeutic domain knowledge. Our writers possess extensive experience across a diverse range of therapeutic areas, including oncology, immunology, cardiology, neurology, metabolic disorders, rare diseases, and infectious diseases. This domain expertise ensures that our deliverables are not only technically sound but also contextually relevant—crafted to reflect the nuances of specific indications, patient populations, and treatment paradigms. Moreover, we stay abreast of emerging scientific trends, therapeutic breakthroughs, and evolving regulatory frameworks. This proactive approach allows us to anticipate changes in documentation expectations and ensure that your submissions are always compliant with the most current global standards.

Integrated Collaboration and Process Efficiency: Medical writing within our organization is a deeply collaborative endeavor. Our writers are integrated members of cross-functional project teams and are involved from early protocol development through to final study reporting. By engaging medical writers early in the clinical process, we ensure alignment on key scientific messages, data collection plans, and endpoint analyses—minimizing the need for downstream revisions and ensuring submission-ready documentation. We employ a standardized, metrics-driven approach to project planning and delivery. Each medical writing assignment is governed by clear timelines, quality benchmarks, and iterative review cycles. Our proprietary templates and SOP-driven processes ensure consistency across documents, while our electronic document management systems (EDMS) enable seamless collaboration, version control, and audit-readiness. Whether operating as an embedded partner within your existing teams or managing the full document lifecycle independently, we are committed to efficiency, transparency, and accountability at every step.

Global Regulatory Acumen and Compliance

This clinical research powerhouse possesses a deep understanding of international regulatory requirements and harmonized standards. Our writers are proficient in ICH guidelines, EMA and FDA submission standards, and regional variations for Asia-Pacific, Middle East, and Latin American markets. We have supported clinical programs for both investigational and marketed products across North America, Europe, India, Japan, and other regulated and semi-regulated regions.

Our regulatory writing expertise is backed by a strong quality management framework. Every document undergoes comprehensive quality review, including peer editing, statistical cross-checks, and medical accuracy assessments. We also conduct document readiness assessments and submission audits to ensure that all deliverables are submission-ready and withstand regulatory scrutiny.

Quality Assurance, Confidentiality, and Ethical Integrity

Quality is a non-negotiable priority within our framework. All medical writing deliverables are reviewed through a multi-tiered QA process that includes senior medical writing oversight, editorial review, and clinical or regulatory subject matter input. We leverage validated document authoring tools and ensure that all data representations are scientifically accurate, ethically sound, and fully compliant with applicable laws and industry standards.

We also adhere to stringent confidentiality protocols. Whether managing proprietary research data, pre-publication manuscripts, or regulatory strategies, our teams operate under strict data protection and non-disclosure practices. Our commitment to ethical authorship, transparency, and data integrity is unwavering.

Tailored Engagement Models to Meet Sponsor Needs

Recognizing the diverse needs of sponsors across geographies and development phases, we offer flexible engagement models. Whether you require a full-service medical writing package as part of an integrated clinical trial solution or standalone document development for a specific milestone, our team is equipped to adapt.

We work with a range of sponsors—from emerging biotech firms to large pharmaceutical companies—and offer both onshore and offshore delivery capabilities. Our scalable team structure allows us to support programs of varying size and complexity, ensuring timely delivery without compromising quality.

Innovation-Driven, Future-Ready Documentation

We are continuously evolving our medical writing capabilities in response to industry innovation and digital transformation. From AI-assisted literature searches and automated document formatting to structured content authoring systems, we leverage technology to drive efficiency, reduce errors, and enhance document quality.

We are also exploring structured content management approaches that support modular content reuse, improve version control, and facilitate faster document updates across related submissions. By integrating technology with scientific expertise, we’re shaping the future of clinical documentation.

Why Choose Us for Medical Writing?

  • Expert team of medical writers with advanced life science and medical degrees

     

  • Proven track record across 150+ clinical trials and global regulatory submissions

     

  • Therapeutic expertise in over 15 therapeutic areas, including high-complexity indications

     

  • End-to-end writing support from protocol to publication

     

  • Robust quality control and document review processes

     

  • Regulatory insight into FDA, EMA, CDSCO, TGA, and global health authority expectations

     

  • Flexible engagement models with scalable delivery capabilities

     

  • Strong ethical framework and strict confidentiality protocols

     

Your Trusted Partner in Scientific Documentation

In a competitive and highly regulated clinical development environment, effective medical writing is essential—not just for compliance, but for clarity, credibility, and clinical success. With this dedicated scientific partner, you gain a team that brings science to life through precise, persuasive, and purpose-driven documentation. Whether you are initiating a first-in-human trial or preparing a global regulatory submission, our medical writing services provide the clarity and scientific integrity needed to move your asset forward with confidence.

Partner with a team that transforms your clinical data into regulatory success and scientific impact.

About Us

ProRelix Research is the best clinical research organization (CRO) with global service capability supporting Phase 1, 2, 3, & 4 clinical trials for Pharma, Biotech, Biopharma, Medical device, Nutraceutical & Herbal companies in US, India, Australia, & Europe.

Services
Subscribe Blogs & Newsletter
Legal Center
Copyright © 2021 Reserved at ProRelix Services LLP .
Inquire Now
close slider







      Register Now

      All the fields are mandatory