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$
USD
I will write and optimize mhra and eu regulatory ectd documents
About this Gig
Are your submissions being bounced back by MHRA? Struggling with variation justifications, labelling updates, or MAA dossier preparation? You need someone who knows how regulators think because I've worked inside MHRA and have granted applications.
I'm a UK Regulatory Affairs specialist with 5+ years' experience managing CMC lifecycle across 500+ licensed products for MHRA and EU markets. I've led 250+ eCTD variation submissions (Type IA, IB, and complex Type II) and 50+ initial MAA dossiers.
What I can write for you:
- SmPCs and PILs
- Module 1 and Module 3 documents
- Type IA / IB / II variation justifications
- MAA dossier preparation and review
- Cover letters and regulatory overviews
- Nitrosamine risk assessments
- MHRA query responses
- Artwork and labelling review
- DCP / MRP variation submissions
- Regulatory impact assessments
All documents are written to MHRA and EMA standards, with submission-ready formatting. Please message me before ordering if you're unsure which package fits your needs.
Document type:
Documentation
•
Regulatory Documents
Industry:
Medical & biotech
Language:
English
Delivery style preference
Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.
FAQ
What types of regulatory documents can you write?
SmPCs, PILs, Module 1 and 3 documents, Type IA/IB/II variation justifications, cover letters, MHRA query responses, nitrosamine risk assessments, labelling reviews, and MAA dossiers. Not sure if your document is in scope? Message me before ordering.
What do you need from me to get started?
Product name, formulation details, submission type, any existing dossier sections, and your target date. For variations, share the relevant change control docs. I'll send a short brief after ordering to collect everything needed.
Will the documents be submission-ready for MHRA?
Yes. All documents follow current MHRA and EMA standards. I previously worked inside MHRA as an operative, so I write with direct knowledge of what the agency expects and what triggers validation failures or queries.
Can you handle EU submissions as well as UK?
Yes. I have experience with MHRA national submissions and EU procedures including DCP and MRP variations. I've acted as CMS partner across multiple EU member states. Documents are tailored to your target regulatory framework.
My submission was queried by MHRA — can you help?
Yes. Share the query letter and I'll draft a compliant response. Having worked inside MHRA, I understand the reasoning behind common queries and can help resolve them efficiently without repeated back-and-forth.
How do you handle confidential product information?
All client information is treated as strictly confidential. I'm happy to sign an NDA before work begins — just ask when you message. Share only what's necessary for the document scope.
Can I request a custom package for ongoing work?
Yes. If you have a pipeline of submissions or need ongoing regulatory writing support, message me before ordering and I'll put together a custom quote. Volume work is priced separately.
Can you deliver faster than the stated timeline?
Rush delivery is available for most documents. Message me with your deadline before ordering and I'll confirm availability. An expedited fee applies depending on the turnaround required.
