Accelerate your HCP Education
and Drug Approval
With Clear, Concise and Compelling
Medical, Scientific, and Regulatory Writing
Accelerate your HCP Education and Drug Approval
Who 3C Serves
How 3C Serves Clients
- Translate complex scientific data into clear, concise, and compelling content
- Accelerate HCP education and drug approval
- Make new drugs available to more patients faster
- Inform and educate healthcare professionals, regulators, and other audiences
- Bring new drugs faster to the market
About Kalpana Shankar, PhD
Backed by 13 years of pharmaceutical and academic experience, a PhD in chemistry, and the ability to work in fast-paced environments, I can help you meet your business goals.
Professional Highlights
EXPERIENCE
- Freelance medical writer and owner of 3C Medical Writing
- R&D project manager
- Quality auditor
- Project coordinator for global team
EXPERTISE
- Non-Clinical Writing
- Abstracts and Posters
- Slide Decks
- Manuscripts
- Corporate Regulatory Documents
- PhD. in Chemistry, Tulane University, New Orleans, LA
- B.S. and M.S in Chemistry, University of Madras, India
- PharMEDium Certified Quality Auditor Certificate
Robert Welch Post-Doctoral fellowship for two consecutive years. This fellowship is awarded to researchers to support fundamental chemical research in the state of Texas.
Client-Focused Services
Backed by experience and scientific expertise in chemistry, I help you accurately and clearly translate complex scientific information and data into the documents that your clients need. I’m used to working in fast-paced environments and meeting deadlines.
General Services
- Medical writing
- Non-clinical reports
- Regulatory writing
- Scientific writing
- Technical writing
- SOPs
- Auditing
- R&D project management
- QA/QC
- Consumer health writing
Medical and Scientific Services
- Abstracts
- Clinical research documents
- Grant writing
- Non-clinical reports
- Posters
- Slide decks
- Book chapters
- More
Regulatory Services
- Pre-IND submissions
- Regulatory meeting requests
- 483 responses
- Corporate regulatory documents
- Technical assessment letters
- Technical justification letters
- More
Portfolio
Company: Prompt Praxis Laboratories, LLC, a cGMP laboratory, registered with FDA and DEA (Vernon Hills, IL)
Project: Wrote sections of a pre-IND document for an oncology project
Audience: Internal and external stakeholders and the US FDA
My role:
- Conducted extensive research
- Wrote 4 sections in compliance with FDA guidelines: Introduction, Regulatory Background, Pharmacological class, and Proposed Clinical Indication
Company: AmerisourceBergan-PharMEDium services, LLC, a manufacturer of ready-to-use compounded sterile preparations (Lake Forest, IL)
Project: Corporate regulatory documents including stability study protocols, SOPs, technical assessment, and justification letters
Audience: Internal marketing, quality assurance, and R&D teams; contract research organizations; and US FDA
My role:
- Wrote consolidated final reports, test results, and data investigations generated from stability studies
Company: Prompt Praxis Laboratories, LLC Project: Work instructions SOP for Empower 3 Chromatography software for data review Audience: Internal quality assurance team
My role:
- Wrote clear and concise instructions that enabled the team to perform efficient analytical data review
Company: Abbvie Biopharmaceuticals, a research-driven biopharmaceutical company (North Chicago, IL)
Project: Scientific and technical documents for reviewing and uploading of scientific analytical data
Audience: CROs, R&D biologists and chemists, internal IT team, and other internal stakeholders
My role:
- Wrote scientific instructions document and created a 12-point standardized checklist
- Wrote technical instructions document for efficient upload of analytical data from external CROs to Abbvie’s internal data server
University of North Texas (Denton, TX)
Project: Two grant proposals
Audience: Grant funders: Robert Welch Foundation, National Institutes of Health (NIH), and National Security Foundation (NSF)
My role:
- Assisted the principal investigator in writing two grant proposals to NIH and NSF, which resulted in $250,000 in funding for research by undergraduate, graduate, and post-doctoral students
Book chapter on (Photochemistry and Photophysics of Coordination Compounds: Osmium) Tulane University (New Orleans, LA)
Project: Book chapter that has been cited more than 60 times in chemical literature searches
Audience: Scientists, researchers, and students
My role:
- Co-authored the book chapter
- Created drawings of complex chemical structures for book chapter.
Does Aspirin help prevent preeclampsia?
Source: Article written for the Health Writer Hub writing course
Project: Consumer health article
Audience: Patients (or public, or patients and general public, as appropriate)
My role:
- Researched and wrote the article
What people are saying
Contact 3C Today
For clear, concise, and compelling medical, scientific, and regulatory writing
847-532-3922
LOCATED IN CHICAGO, IL
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