Book a Writing & Translation Consultation with Abhijath M. | Upwork

Writing & Translation Consultation with Abhijath M.

5.0 · 28 reviews

I can help you in terms of consultations for Regulatory affairs/Clinical research/Medical writing for Drugs, Devices, Cosmetics & Neutaceuticals.
I have been into Pharmacovigilance, Regulatory Affairs, Clinical Research, Medical Affairs and now into Business Development.
Looking forward to meet !

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About Abhijath

Regulatory Affairs Consultant - IND, NDA (USFDA) | Formulation Advisor

100% Job Success

5.0 (28 reviews)

Kozhikode, India - 2:59 am local time

I’m Dr. Abhijath Murali Pharm.D (BCMAS, RAPS-certified, PMP) - A Top Rated Plus Freelancer with 90k+ earnings from Upwork with cross-functional experience at IQVIA, Cipla, IPCA, and Accenture.

Past Experience :

- I am having 8+ years of combined experience in Regulatory Affairs + Clinical Research + Medical Affairs - guiding sponsors from first-in-human to post-market.
- I help in formulation of Dietary Supplements in US, EU, India.
- I help biotech and pharma teams design inspection-ready studies, secure ethics approvals, and deliver submissions that move programs forward on time and audit-proof.
- MDR/IVDR support, Clinical Evaluation Reports, Performance Evaluation Reports, and technical file documentation.
- I perform Regulatory gap assessments, audit readiness, health authority response support, and compliance strategy.

Expertise on : USFDA • EMA • CDSCO

I support IND/CTA/NDA submissions, eCTD documentation, labeling compliance, QA workflows, and clinical writing across startups, CROs, and emerging biotech teams. My focus is delivering accurate, inspection‑ready documents that accelerate development timelines without compromising compliance.

What I Deliver :

- IND, CTA, NDA, and ANDA module writing, particularly for CTD Modules 2 to 5.
- Submission Preparation : eCTD support (Modules 1–5)
- Labelling : US Prescribing Information, SmPC, CCDS review, labeling compliance, and content alignment.
- SOP development, QA documentation, CAPA logs
- Regulatory Writing : Clinical writing: Protocols, IBs, CSRs, safety summaries
- Regulatory intelligence & documentation QC
- Variation Preparation & Renewal Analysis (US & EU)

Why Clients Work With Me :

- RAC (US,EU, Global) certified
- Strong foundation in FDA, EMA, HC, and ICH frameworks
- High accuracy, fast turnaround, and structured workflows
- Experience validating regulatory datasets used in AI systems
- Ability to produce submission‑ready content across drugs, biologics, and devices

If you need support preparing a submission, reviewing labeling, drafting SOPs, or QC‑checking regulatory documents, I can step in immediately and deliver with precision.
Send me a message with your project details - I typically respond within a few hours.

Also, If your regulatory documentation needs to be ready for submission and not sent back for repeated revision, share your project brief. I can help turn complex regulatory content into a strong, well-structured submission package.

Keywords : Regulatory Affairs • IND/IDE • 510(k) • SaMD • ICH-GCP • IRB • Clinical Trial Design • Protocol Development • Pharmacovigilance • Medical Writing • CSR • IB • EDC/CRF • EMA • CDSCO • US FDA • 505 b(1) • 505 b(2)

What to expect

Schedule the consultation

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Get advice for your custom needs

Share details about your project and what you want to talk about. The freelancer will review and reach out if they have questions.

Join the Zoom meeting

1-on-1 meeting with the freelancer to discuss your needs and project.

Approve the work

The freelancer will finish up the documents you asked for and send them to you for approval:

Before the consultation

Here’s what Abhijath will need to know before you meet

Tell me in brief about yourself. Also, How can I help you effectively ?

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He provided clear communication throughout the consultation and offered valuable regulatory insights. Their guidance was professional, well informed, and highly useful!

Great consultation! Will work with again.

Abhijath is very knowledgable and explains details in a clear and concise manner. His perspective is very useful and provides great guidance.