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