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Biologics and Biosimilars Regulatory Writing, Statistics and Publications
Pubrica supports developers of biologics, biosimilars and advanced therapies with regulatory writing, statistical analysis and scientific publications. We prepare analytical similarity summaries, immunogenicity reports, clinical study protocols and reports, CTD Module 2.5 and 2.7 documents, risk management plans and publications. Biosimilar documents are structured to show comparability with the reference product, in line with ICH Q5E and EMA and FDA biosimilar guidance.
Each document states the guidance and version it was prepared to.
- Structured comparability reporting
- One designated project lead
- Your SOPs and templates
- Mutual NDA on request
- You remain the named sponsor
Service Scope
Regulatory writing for biologics and biosimilar applications
A biosimilar application is assessed on the totality of evidence. We present the analytical, nonclinical and clinical data together so assessors can follow the comparability case with the reference product.
Approach
Totality of evidence
Analytical, nonclinical and clinical data presented as one consistent comparability case.
Standards
ICH and the biosimilar guidelines
ICH Q5E and EMA and FDA biosimilar guidance, applied at the current edition.
Coordination
One project lead
One lead coordinates the comparability summary, study reports and publications.
Our Services
Biologics and biosimilar documents we prepare
Available as individual documents or as a full programme. If a document relies on material prepared elsewhere, the initial assessment reviews that material first.
Documents and applicable standards
Full Service List
All services available for biologics programmes
Services are grouped by type of work so you can find what you need. Services governed by a different regulation are listed on the relevant industry page.
47 services, grouped
Available individually or together. When several services run at once, one project lead coordinates them so the documents stay consistent.
Who We Serve
Teams we work with on biologics programmes
We support the following functions at biologics and biosimilar developers.
Who we support
Our compliance and guideline standards
Guidelines and standards we work to
Each standard is applied at its current edition, with the date it was checked. Where a standard has changed recently, the deliverable records which version was used.
Applicable standards
Use of AI Tools
AI tools support search and formatting. They are not used to write your scientific content.
This policy applies to every service and every industry, regardless of deadline.
Our AI policy
How it works
Our five-step process, starting with a free assessment
We review your materials before providing a quote.
One
Initial assessment
Two business days, at no cost. We set out what the work requires, who will lead it and the cost.
Two
Named team
We confirm who is assigned and their relevant experience before work starts.
Three
Outline approval
You approve the content and sources for each section before drafting begins.
Four
Draft and review
Independent review, quality control and reference verification, each signed off separately.
Five
Handover
The final deliverable with its working files under version control, revised within the agreed scope.
Throughout
One project lead
One project lead coordinates the work so all documents remain consistent.
Project Inputs
Send us your existing materials and we will identify any gaps.
Many projects start with incomplete material, so the initial assessment includes a review of what is available.
You send
Existing materials
Existing documents, your templates and the required completion date.
We send back
Written assessment
What is available, what is missing and the condition of existing material.
Then
Packages
A quote for the programme, with the named team and timeline, before you commit.
Our experts
Our biologics writing and statistics team
Writers are assigned by subject and industry, not by availability. They hold a master’s degree or doctorate in life sciences, medicine, pharmacy or a related discipline, with at least five years of experience in the field. Keeping up to date with the relevant guidance is part of their regular work.
Specialists involved
Sample work
Example deliverables and methods
Published with client agreement and redacted where requested.
Benefits
Practical benefits for biologics programmes
The benefits clients mention most often.
What you get
Packages
Pricing based on programme scope
Page count does not reflect the work involved, so we do not price by length. The free initial assessment defines the work and gives you a quote you can budget for.
First
Initial assessment
Free, within two business days. A written assessment of the work required.
Then
A written scope
Deliverables, standards, named team and timeline, agreed before work starts.
Quoted
Per programme
One price for the agreed scope, with revisions included rather than charged per round.
Quality Assurance
Revisions within the agreed scope
If a deliverable does not meet the scope you approved, we revise it at no additional charge and repeat the independent review.
What is covered
FAQs
Common questions about biologics and biosimilar work
The assessor asks a different question. A new active substance demonstrates efficacy and safety directly. A biosimilar shows that, after analytical and functional comparison, remaining uncertainty is small and the clinical data only needs to confirm similarity. The Module 2.5 clinical overview should follow that structure, not the format used for a new active substance.
We write it up; the analytical work stays with your team. We turn the comparability data your CMC team generates into the similarity summary used in the clinical overview, and we point out any gaps an assessor is likely to notice.
Yes, for the documentation. Interchangeability under FDA guidance usually requires switching study data. We report that data so it addresses the switching question directly, rather than leaving it to be inferred from safety tables.
Yes, this is our standard arrangement for sponsors. We work within your quality system, supported by our ISO 9001:2015 certified process.
Each deliverable goes through independent review by a second qualified person, quality control and reference verification, each signed off separately. The review reports are supplied with the deliverable.
We do not operate your pharmacovigilance system. We write the risk management plan and periodic reports, but case processing and reporting to authorities remain within your PV system under your qualified person. We do not run analytical or clinical work, and we do not audit or certify GMP or GCP compliance. We do not claim authorship of your science.
Related services
Related industries and services
If your project spans more than one area, the same team can support it.
Other industries and topics
Discuss your biologics or biosimilar project requirements
The initial assessment is free and takes two business days. You receive a written summary of the work required and who would lead it.