Regulatory Writing
Our knowledgeable professionals produce clear, content-ready to submit and compliant with globally accepted regulatory standards.
Regulatory Writing for Life Sciences, Pharma and Research
Full Compliance, Clarity, and Accuracy in Scientific Data Submission
At Pubrica, we specialize in regulatory writing services for pharmaceutical, biotech, and medical device companies, ensuring your scientific and clinical data is translated into clear, accurate, and regulatory-compliant documents that meet global submission standards.
Whether you’re preparing for an IND, NDA, BLA, MAA, or CTD submission, our team of experienced regulatory writers ensures that your data is well-organized, truthful, and fully aligned with international guidelines such as ICH, FDA, EMA, PMDA, and MHRA.
We help pharmaceutical companies, clinical research organizations (CROs), and medical device manufacturers by:
- To help you translate your complex scientific and clinical data into organized and compliant, submission-ready documents.
- To help you comply with international regulatory regulations (ICH, FDA, EMA, PMDA, CTD).
- To avoid delays and rejections caused by insufficient documentation, formatting errors, or non-compliance.
Our experienced regulatory writers and experts in clinical regulatory writing understand that and provide services to help you develop your data into organized, compliant documents ready for regulatory submission.
We work in close collaboration with your project teams to produce documents with a clear understanding of the expected clarity required for investigational submissions, marketing applications and reporting, and regulatory expectations. Our tailored writing service seeks to minimize approval timelines and facilitate a successful regulatory strategy, Partner with Pubrica to ensure your regulatory documents are clear, compliant, and submission ready.
We simplify the regulatory writing process—from data compilation to submission—helping you meet global compliance standards. Accelerate your approval timelines with Pubrica’s expert regulatory writing support, delivering clarity, consistency, and compliance in every document.
1000+ regulatory documents delivered successfully
Experienced writers with expertise in 40+ therapeutic areas
100% confidentiality & regulatory standards compliant
Fully compliant with global regulatory authority standards FDA (US), EMA (EU), MHRA (UK), PMDA
Who We Serve
Our regulatory writing services serve to aid pharmaceutical companies, biotech companies, CROs, and medical device companies with every phase of their product development and regulatory submission processes. Whether you are navigating early phase trials or global market access, Pubrica produces accurate and compliant regulatory writing specific to your needs.
Pharmaceutical and Biotechnology Companies
We assist pharma and biotech companies create high-quality, compliant regulatory documents including INDs, NDAs, MAAs and safety reports that meet the regulatory requirements imposed by the global regulatory agencies.
Clinical Research Organizations (CROs)
CROs need our regulatory writers to prepare their regulatory documents for clinical trials including their protocols, investigator brochures (IBs), clinical study reports (CSRs) and Clinical Trial Documents (CTDs) that comply with International Conference on Harmonization (ICH) regulations and Good Clinical Practice (GCP) requirements.
Medical Device Companies
We help device manufacturers to develop technical documentation, clinical evaluation reports (CERs) and submissions in accordance with their regional standards including EU Medical Device Regulation (MDR), FDA, and TGA.
Medical Device regulation
Our services include regulatory writing, which can include thousands of devices. i.e.: with technical files, clinical evaluations, and 510 submissions.
Academic and Research Institutions
We assist research institutions in converting their research findings and data into regulatory compliant document publication or submission for approvals, including clinical trials, ethics submissions, and statuary applications to finance grants, etc.
Regulatory Affairs and Medical Affairs
Our consultants' combined experience is relied upon by internal departments when needing to draft, have documents or messages reviewed and other written communication or documentation for the purpose of other regulatory activities.
Our Regulatory Writing Services
We appreciate the value of regulatory writing in obtaining product approval and market access, and for ongoing compliance. Our services can assist life science companies at every stage of product development—from early-stage clinical documentation to post-marketing commitments.
Clinical & Nonclinical Documentation
- Clinical Study Protocols (Phases I–IV)
- Investigator Brochures (IBs)
- Clinical Study Reports (CSRs)
- Nonclinical Study Reports & Summaries
- Patient Narratives
Regulatory Dossier Preparation
- Common Technical Document (CTD) Modules 2–5
- Investigational New Drug Applications (IND)
- New Drug Applications (NDA)
- Biologics License Applications (BLA)
Applications (MAA) Agency Communication Documents
- Briefing Documents (FDA, EMA, etc)
- Meeting Packages & Backgrounders
- Orphan Drug Designation Applications
- Paediatric Investigation Plans (PIPs)
Medical Device Regulatory Writing
- Clinical Evaluation Reports (CERs)
- Performance Evaluation Reports (PERs)
- Technical Files & 510(k) Submissions
- Risk Management & Benefit-Risk Reports
Submission Strategy & Support
- Regulatory Pathway Consulting
- Submission Project Management
- Gap Analysis & Document Audits
- Submission Portal Assistance (eCTD, ESG)
Safety and Pharmacovigilance Documentation
- Risk Management Plans (RMPs)
- Periodic Safety Update Report (PSURs)
- Development Safety Update Report (DSURs)
- Summary of Product Characteristics (SmPCs)
Post Marketing Support
- Variations and Renewals Documentation
- Post Marketing Study Report
- Labelling Updates & Review
- Risk Communication Documents
Quality and Regulatory Compliance
- ICH and GCP Compliance Review
- QC of Regulatory Documents
- Internal SOP Development Support
- Health Authority Query Response Support
Specialized Document Services
- Layperson Summaries, per EU Regulation
- Plain Language Summaries (PLS)
Disciplines We Support
With our regulatory writing services, we work across a broad range of scientific, clinical, and technical disciplines.
Whether you are developing a new therapy, applying for a medical device, or need safety documents, our subject matter expertise indicates your regulatory documents will be accurate, compliant, and purposefully constructed for specific global health authority requirement.
We support life sciences companies with writing that connects innovative research and regulatory expectations, in fields like molecular biology, genomics, proteomics, cell therapy, and biotechnology. We ensure your documents are scientifically acceptable and compliant with ICH and international standards.
Our regulatory writers have significant experience drafting documents related to clinical trials, pharmacovigilance, and health authority submissions in many therapeutic areas – everything from clinical study reports (CSR) to risk management plans (RMP). Our team prepares complex documents and adheres to regulations set forth by FDA, EMA, MHRA, and PMDA.
From drug discovery to lifecycle management, we support pharmaceutical companies with submission-ready documentation including INDs, NDAs, MAAs, CTD modules and other documentation that are published in accordance with regulatory and scientific expectations.
We supply regulatory writing for medical device manufacturers including Clinical Evaluation Reports (CERs), Technical Documentation, 510(k) submissions, and Post-Market Surveillance (PMS) reports. Our experts are very familiar with EU MDR, FDA, and other global regulations.
We provide regulatory writing for products such as cell and gene therapies, biologics, biosimilars, and RNA-based therapeutics. Our writers ensure innovative biotech submissions meet increasing global regulatory requirements and scientific standards.
We write documentation for public health studies, vaccines, and population-level interventions, including study protocols, safety summaries, and briefing books for regulatory advisory meetings.
Writing by Regulatory Need / Type
Choose a regulatory writing service based on your development phase, type of document, submission model, or worldwide regulatory authority.
At Pubrica, we recognize that regulatory writing is not a cookie-cutter approach. While you may be preparing for a first-in-human trial or responding to post-marketing commitments, our solutions are framed within the exact regulatory, clinical, and scientific context of what you are making. Our services are based upon global standards such as ICH, FDA, EMA, MHRA, PMDA, and others. Whether you need a clinical study protocol, CTD module, or risk management plan, we get it submission-ready, scientifically accurate, and regulatory compliant.
By Regulatory Stage
- Preclinical activities to post-marketing documents
- Phase I – IV clinical trial support
- NDA, MAA, and BLA submissions
By Document Type
- Protocols, CSRs, IBs, CTDs, RMPs, CERs
- Briefing books and regulatory responses
By Regulatory Model & Standards
- FDA, EMA, PMDA, TGA, Health Canada, EU MDR
- eCTD format and ICH & GVP guidelines
- Dossier harmonization, where applicable, to support cross regional submissions
(Optional Add-Ons)
- Advantages of Tailored Writing:
- Guaranteed to be compliant with current regulatory guidelines
- Enhances quality of submissions and expedites approval timelines
- Minimizes chances of rejection / resubmission
Our services are tailored to:
- The stage of the product development life cycle (from preclinical to post-market)
- Type of regulatory document being submitted (IND, CSR, CER, etc.)
- Requirements of the regulatory authority (FDA, EMA, etc.)
- Regional requirements (eCTD, EU MDR, etc.)
Regulatory Writing Sample Work
Download the full Report Now
- Literature review
- Manuscript (with journal formatting)
- Systematic review with PRISMA
- Thesis chapter
Speed Up Your Regulatory Writing with Pubrica
Gain access to your dedicated regulatory writing expert, ensuring high-quality, fully compliant documentation tailored to agency requirements and your development objectives.
Testimonials
" Pubrica's regulatory writing team helped us streamline our NDA submission. Their understanding of FDA requirements and quick turnaround was instrumental in keeping us on schedule. "
" We partnered with Pubrica for our EU MDR documentation, and the CERs they delivered were thorough, compliant, and professionally written. We cleared our audit with zero findings. "
" From CTD modules to briefing documents, Pubrica has been our go-to partner. Their writers know exactly what agencies expect, and that’s saved us valuable time during submissions. "
" Their eCTD-ready documents were perfectly formatted and accepted without a hitch. Highly recommended for anyone seeking dependable regulatory writing support. "
Our Packages
Regulatory Dossier Writing
Clinical Trial
Documents
Safety & Pharmacovigilance Writing
Complete writing and compilation of documents for global regulatory submissions.
Services include:
- Completed Common Technical Document (CTD), Modules 2-5
- IND, NDA, BLA & MAA, applications
- Investigational Medicinal Product Dossiers (IMPDs)
- Summary Documents – Clinical, Nonclinical, Quality
- Clinical Study Reports (CSR)
What you receive:
- Health authority compliant content (FDA, EMA, etc.)
- ICH guideline compliant
- Submission-ready documents (will work in eCTD format)
Specialized clinical trial writing support for all phases.
Examples of clinical trial documentation I create:
- Clinical trial protocols (Phase I–IV)
- Investigator brochures (IBs)
- Patient narratives and case listings
- Informed consent forms (ICFs)
- Clinical development plans (CDPs)
What you get:
- Scientifically sound and audit-ready documents
- Consistent with trial designs and regulatory expectations
Thorough documentation for drug safety and risk mitigation throughout the product lifecycle.
Our services include:
- Risk Management Plans (RMPs)
- Development Safety Update Reports (DSURs)
- Periodic Safety Update Reports (PSURs)
- Adverse event summaries
- Benefit-risk evaluations
What you’ll receive:
- Compliance with GVP and ICH E2E guidelines
- Safety data integration from multiple sources
- Transparent and actionable documentation for regulators.
Regulatory Writing for Medical Devices
Health Authority Communication Support
Labelling and Lifecycle Documentation
Regulatory writing provides support to clients with their device submissions according to international standards.
Services we offer are:
- Clinical Evaluation Reports (CER)
- Performance Evaluation Reports (PER)
- Technical documents for CE marking
- Post-market surveillance report
What you receive:
- Devices that are compliant with the MDR and FDA
- Support from domain experts in the device arena
- Document tailored to the risk class and type of device.
Expert development of documentation used to inform regulatory interactions and decisions.
Our services include:
- Briefing books and meeting packages (FDA, EMA, etc.)
- Questions and responses to health authority questions
- Rebuttal letters and appeal documentation
- Advisory meeting support documents
What you receive:
- Strategic placement of data and rationale
- Clear, concise, and persuasive content
- Alignment of your document with agency expectations
Continued regulatory writing support for marketed products and label changes.
Services include:
- Summary of Product Characteristics (SmPCs)
- Product Information Leaflets (PILs)
- Label changes and variations
- Review of promotional material for compliance
What’s Included
- Regional compliance (FDA, EMA, etc
- Regulatory strategy and safety teams’ coordination
- Timeliness of updates for label changes and renewals
Optional Add-Ons (Regulatory Writing)
- Regulatory Gap Analysis
- Submission Portal Support (eCTD upload, FDA / EMA portals)
- Health Authority Query / Response Writing
- Document QC & Medical Editing
- Custom Templates (per agency or sponsor requirements)
Call to Action
- Need help choosing a package? [Talk to a Specialist]
- Ready to begin? [Upload Your Project]
- Want a custom quote? [Request a Proposal]
Frequently Asked Questions
We specialize in a variety of regulatory documents, including Clinical Study Reports (CSR), Investigator Brochures (IB), Common Technical Documents (CTD) Summary of Product Characteristics (SmPC), Risk-Benefit Analyses, Regulatory Submission Dossiers (FDA, EMA, SFDA, etc), Guidance Documents, Device Technical Files, etc. We offer our services to suit regional regulatory processes and specific agency requirements.
Our medical writers adhere to international regulatory standards such as ICH E3, E6, E9, EU MDR, FDA, SFDA, etc. We put the same rigor into assessing your documents against these standards for accuracy and completeness, as well as contextually evaluate the most up-to-date regulatory expectations.
The turnaround time will depend on the type and complexity of the documents:
- Short regulatory summaries: 7-10 business days
- Full Clinical Study Reports: 15-25 business days
- Complex dossier and multi-module CTDs: 25+ business days
If you need submissions of an urgent or expedited nature, we can provide this service for an additional fee.
We uphold confidentiality through NDAs, encrypted data transfer, secure cloud storage and ISO Information Security protocols. We will never share or use your proprietary and sensitive information without your express consent.
Yes. We provide support for preparing responses to agency queries, protocol amendments, and document updates to maintain submission compliance and facilitate smooth review processes.
Definitely. We make sure that your documents meet the formatting requirements of certain regulatory agencies, including proper templates, numbering, font standards, and consistent terminology, which leads to readability and professionalism.
Our quality assurance is multi-tiered and will include:
- Expert scientific and regulatory assessment
- Cross-checks to ensure data are accurate and consistent
- Verification with regulatory guidelines for compliance
- Plagiarism and reference checks
- Final editorial check before delivery
We specialize in regulatory submissions for medical devices (Class I – III), Software as a Medical Device (SaMD), and Digital Health Solutions. This includes Clinical Evaluation Reports (CER), Instructions for Use (IFU), Post-market Surveillance reports, and validation protocols.
Really, our project managers coordinate workflow to the minutiae to meet deadlines while not compromising the quality of our work. We plan for adequate resources and stay communicative as we develop to deliver on time.
Yes, we can supply sample documents within your therapeutic area or document type, upon request, to show our writing quality and compliance capabilities.
We offer multilingual services through native speaking writers or trusted partners to meet the local regulatory language requirements and be sure to remain accurate.
A dedicated coordinator is assigned to each project who becomes your point of contact via email, phone or video calls for periodic updates, feedback and clarifications
We provide revisions, at no charge, in the scope agreed upon, to ensure your dissatisfaction is addressed. If we still did not meet expectations, we will work with you directly to address your concerns, or provide refunds, as allowed in our quality assurance policies.
Yes. Our expertise covers regulatory agencies throughout the world, such as SFDA (Saudi Arabia), MHRA (UK), TGA (Australia), Health Canada, PMDA (Japan), and many others, helping you with regional submission requirements.