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English
$
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I will perform regulatory documentation review and dossier assessment
Seema J
About this gig
- Are you looking for professional support for pharmaceutical regulatory documentation and dossier review?
- I help pharmaceutical companies, regulatory consultants, and healthcare organizations review regulatory documents and assess submission readiness. With over 9 years of experience in Regulatory Affairs, I have worked on regulatory documentation, compliance assessment, CMC document review, and regulatory data management.
- This gig is ideal for pharmaceutical manufacturers, regulatory consultants, generic companies, and healthcare organizations.
- Services included:
- Dossier review and gap assessment
- CMC documentation review
- Regulatory compliance assessment
- Stability and specification review
- Submission readiness evaluation
- Document quality checks
- Why choose me?
- 9+ years of pharmaceutical experience
- Experience with global regulatory projects
- Strong attention to detail
- Quality-focused approach
- Professional communication and timely delivery
- Please contact me before placing an order so we can discuss your project requirements and ensure the best possible outcome.
Get to know Seema J
Seema J
REGULATORY AFFAIRS LEAD
- FromIndia
- Member sinceJan 2026
- Avg. response time1 hour
Languages
English
Regulatory Affairs Specialist with 9 years of experience in the pharmaceutical industry, including with a proven track record of supporting global regulatory submissions, tender bid processes, and compliance for both regulated and semi-regulated markets. Adept in leveraging key regulatory tools and platforms such as Veeva Vault, REDS, ORION, CAST, Amplexor, and Darius System to drive submission accuracy and streamline documentation workflows. Demonstrated expertise in: Regulatory planning, authoring, and quality assurance of dossiers, Data collation and quality control.
Other Regulatory Compliance Consulting Services I Offer
FAQ
Q: What types of pharmaceutical documents do you review?
A: I review regulatory dossiers, CMC documents, specifications, stability reports, validation reports, quality documents, and submission-related documentation.
Q: Do you prepare regulatory submissions for health authorities?
A: I provide documentation review, gap assessment, and submission readiness support. Final submissions remain the responsibility of the client or regulatory authority representative.
Q: Is my information kept confidential?
A: Yes. All documents and project information shared during the engagement are treated as confidential and used only for the assigned work.
