You will get support on pharmaceutical submission to ema or eu authorities

Yamira M.Status: Offline
Yamira M. Yamira M.
4.7
Top Rated

Let a pro handle the details

Buy Legal Consulting services from Yamira, priced and ready to go.
Yamira M.Status: Offline
Yamira M. Yamira M.
4.7
Top Rated

Let a pro handle the details

Buy Legal Consulting services from Yamira, priced and ready to go.

Project details

I specialize in EU regulatory submissions for food, supplement, and pharma products, offering streamlined support for product notifications and market entry. My projects stand out by combining deep regulatory knowledge with practical execution—ensuring fast, compliant submissions across multiple EU markets.
Field of Law
Health & Medical
Target Country
Worldwide
Language
English, German
Service Type
Legal Assistance, Legal Writing, Documentation Review, Contracts, Regulation & Compliance, Trademark Registration
What's included
Service Tiers Starter
$50
Standard
$120
Advanced
$250
Delivery Time 1 day 5 days 10 days
Number of Revisions
1220
Optional add-ons You can add these on the next page.
Additional Revision
+$50
4.7
16 reviews
88% Complete
1% Complete
(0)
6% Complete
6% Complete
1% Complete
(0)

ML

Marie L.
5.00
Jun 2, 2026
Chocolate Fruits Always a pleasure to work with Yamira.

ML

Marie L.
5.00
Jun 2, 2026
Artisan Cake Request for LMIV Translation Always a pleasure working with Yamira.

KA

Kathleen A.
5.00
May 18, 2026
Cosmetic Safety Documentation (EU) – 7 Products

EC

Esef C.
5.00
Mar 27, 2026
Registration of PureNADH supplement for German market Yamira was great to work with. She is detail-oriented, reliable, and delivers high-quality work with a strong sense of accountability.

Communication was clear and efficient throughout the project, and she handled everything in a professional and structured way.

I would definitely recommend her and would be happy to collaborate again in the future.

HA

Hisham A.
3.00
Feb 23, 2026
German proofreading of medical device material Generally OK, but I think the job was a bit rushed, while attention to the details was not optimal.
Yamira M.Status: Offline

About Yamira

Yamira M.Status: Offline
Regulatory Compliance I Quality Assurance I GxP
95% Job Success
4.7  (16 reviews)
Berlin, Germany - 4:29 am local time
Welcome! I am Yamira Munkel, a seasoned Regulatory and Quality Expert with over a decade of experience in the pharmaceutical industry. With GxP-Background. Certified PRRC (EU MDR 2017/745 / EU IVDR 2017/746, Responsible Person (GDP Directive 2001/83/EC), Responsible Person (Cosmetics EU Cosmetics Regulation 1223/2009).

I am passionate about guiding businesses through complex pharmaceutical regulatory requirements. My expertise includes technical writing, such as Standard Operating Procedures (SOPs), and in-depth knowledge of Quality Management Systems (QMS) that comply with ISO standards and global regulatory frameworks.

Furthermore, my experience encompasses EudraLex Volume 4, ensuring that pharmaceutical products adhere to jurisdictional compliance standards. I also possess extensive expertise in GDPR, Computer System Validation (CSV), lead auditing, CE certification, and ISO 9001 and ISO 13485 compliance. Research, technical documentation, and regulatory submissions are among my core competencies.

If you require regulatory affairs expertise, quality management system guidance, or support with regulatory submissions in the pharmaceutical industry, I am here to assist. My vast experience in regulatory and quality affairs ensures that your products meet international standards and compliance requirements.

Let’s collaborate to bring your pharmaceutical products to market with confidence and compliance!

I look forward to connecting with you!

Steps for completing your project

After purchasing the project, send requirements so Yamira can start the project.

Delivery time starts when Yamira receives requirements from you.

Yamira works on your project following the steps below.

Revisions may occur after the delivery date.

Review all documents

Review all documents if they comply with the law and give adjustment advices.

Submission to the authorithies

Documents will be submitted to the authorities with all required data, note if you want to do it by a consultant (me) you need a formal power of attorney (does not need to be signed by a notary)

Review the work, release payment, and leave feedback to Yamira.