Hire the Best Pharmaceutical Industry Specialists
in India

With 9+ years of hands-on experience in pharmaceutical Quality Control, I specialize in QC SOPs, STPs, AMV and inspection-ready documentation that regulators expect to see during licensing and GMP inspections. 🔬 My expertise includes: ✔ Analytical Method Validation (ICH Q2) ✔ SOP drafting, review & compliance formatting ✔ QC documentation & data integrity ✔ WHO & EU-GMP guideline compliance ✔ Audit-ready reports & protocols ✔ Analytical Method Validation Protocols “I specialize in Analytical Method Validation (HPLC, GC, UV-Vis, dissolution) for APIs and finished products as per ICH, WHO, and EU-GMP guidelines. I prepare regulatory-ready protocols, reports, and SOPs.” I focus on clarity, accuracy, and regulatory acceptance, ensuring your documents are ready for internal audits, regulatory submissions, and inspections. If you need a reliable QC documentation expert who understands regulatory expectations, let’s work together.

Market Research & Competitive Intelligence Specialist | Pharma, Biotech & Healthcare Analytics With 4+ years of specialized experience in pharmaceutical and healthcare market research, I deliver data-driven insights that drive strategic decision-making for global pharma companies. ✓ Core Expertise: • Patient-Based Forecasting & Epidemiology Models • Competitive Intelligence & Market Landscape Analysis • Pharma/Biotech Analytics (Oncology, IVD, MedTech) • Clinical Trial Analysis & Patent Research • Brand & Product Forecasting • Secondary Data Research & Market Sizing ✓ Professional Impact: • Built 50+ patient-based and service-based forecasts for global pharma clients • Developed patient flow models for oncology products at Merck Sharp & Dohme (MSD) • Delivered competitive intelligence for MedTech stakeholders at IQVIA • Improved forecasting accuracy by 10% through streamlined analytical approaches • Led analysis teams delivering market forecasts in pharma and biotech domains ✓ Industry Specialization: • Pharmaceutical & Oncology • Biotechnology • Medical Devices & Diagnostics (IVD, Immuno-chem) • Healthcare Analytics I combine strong analytical capabilities with deep pharma domain knowledge to provide actionable market intelligence. My approach emphasizes accuracy, timely delivery, and strategic value for clients. Let's discuss how my market research expertise can support your pharmaceutical or healthcare analytics project.

I am a Pharmaceutical drugs data analyst, Data entry specialist, Experienced in secondary research, Worked for various databases to capture and analyze drugs Pipeline and marketed data form various sources. Drug Pipeline analysis, Clinical trial data analysis form various sources into pharma databases. Finding Key patents for Drugs, Analyzing drug revenue and sales forecasting, writing reports for clients to take better decisions. Knowledge on sources & data mining/analysis from UDFDA, EMA, and other regulatory websites. 1.Drug Pipeline Analysis(Company, MOA, target, Indication, Molecule type-Small molecule or Biologic, etc.), review designations. 2.Drugs sales and revenue, sales forecasting. 3.Finding Key Patents for drugs- off-patent 4.Worked for various pharma databases. 5.Analysis of market entry of generics 6.Capturing Drug mechanism of actin, indication, dosage from Drug labels into databases. 7.Capturing data form publications/Journals/Conferences/Abstract and Annual Reports, Sec filings. 8. Data Entry into excel sheets/databases through web search/internet search 9. Monitoring Orange Book, P-IV litigations, Orphan drugs, Exclusivities 10. Lead generation, KOL/HCP - Health care professional data search 11. Literature search from PubMed, ScienceDirect, Elsevier, Google Scholar, etc.

Hi! I'm a pharmacy graduate with hands-on experience in FDA regulatory work. I help businesses like yours get their products registered and compliant for the U.S. market. Whether you're launching something new or managing ongoing submissions, I can take care of the technical details so you can focus on growth. Services I Offer: ✅ Amazon Product Listing & Reinstatement Support ✅ Human & Animal Drug Listing (NDC Code) ✅ OTC & Cosmetic Product Registration ✅ Dietary Supplement Submission & Label Review ✅ Facility Registration via FURLS / CDER Direct ✅ SPL/XML File Creation & ESG Account Setup ✅ Animal Feed & Veterinary Product Listing ✅ U.S. Import/Export Documentation & Compliance ✅ DUNS Number Registration & Address Updates ✅ Label & Artwork Review, Editing, and Finalization I understand how confusing and time-consuming FDA processes can be. I’m here to make it easier, faster, and stress-free — with clear communication and accurate, timely work. Let’s get your product FDA-ready!

I’m Dr. Abhijath - a Top Rated Plus Freelancer with $100K+ earned on Upwork, helping pharma, biotech, medical device, and dietary supplement companies with Regulatory Affairs, FDA submissions, product formulation, and clinical/medical documentation. I specialise in Regulatory Affairs for Drugs & Medical Devices and also work as a Drug & Dietary Supplement Formulation Expert. I’m a Pharm.D with a postgraduate qualification in Regulatory Affairs and currently work as a Regulatory Lead (Contract) on U.S.-focused programs. If you’re developing a pharmaceutical, biotech, nutraceutical, dietary supplement, or medical device product, I can help you turn the science behind it into a clear, compliant, submission-ready and market-ready package. My experience across Regulatory Affairs, Clinical Research, Medical Affairs, Pharmacovigilance, and formulation science allows me to look beyond just one document. I understand how the product, clinical evidence, formulation, claims, labeling, regulatory strategy, and submission documentation need to work together. Clients typically hire me for: • U.S. FDA regulatory strategy and submission support • IND, NDA, ANDA and CTD/eCTD documentation • Pre-IND preparation and FDA correspondence • Regulatory, clinical, CMC and medical writing • Protocol, Investigator’s Brochure and Informed Consent Form review • Dietary Supplement & Nutraceutical Formulation - U.S., EU & India • Ingredient selection, scientific rationale and formulation optimization • Supplement claims, labeling and technical documentation • Medical Device 510(k) regulatory support• EU MDR & IVDR documentation • Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) • Medical Device technical documentation and regulatory gap assessment • Clinical research, ethics and IRB submission support I focus on understanding what you are trying to develop, where you want to market it, what regulators will expect, and what needs to be done to get there. You’ll get clear communication, practical recommendations, scientifically defensible documentation, and work developed with regulatory review in mind - not simply documents created to complete a checklist. Whether you are preparing an FDA submission, developing a new supplement formulation, starting a clinical program, or bringing a medical device to market, I can support you from strategy through execution. Have a regulatory or product development challenge? Send me a message and let’s discuss the best way to move your project forward. Areas of Expertise : Regulatory Affairs | FDA Compliance | FDA Regulatory Consulting | IND | NDA | ANDA | 505(b)(2) | CTD | eCTD | CMC | Regulatory Writing | Medical Writing | Clinical Research | Clinical Trial | Protocol Development | Investigator’s Brochure | Dietary Supplements | Nutraceutical Formulation | Product Formulation | Supplement Formulation | FDA Labeling | Regulatory Compliance | Medical Devices | 510(k) | EU MDR | IVDR | Clinical Evaluation Report | Performance Evaluation Report | Technical Documentation | Pharmacovigilance

I am a Veeva Network-certified Data Steward with 6000+ hours supporting pharmaceutical and life sciences clients through Upwork. As a Top Rated Plus freelancer with a 100% Job Success Score, I specialize in HCP/HCO data management, duplicate resolution, suspect matching, and CRM data quality operations at scale. Currently, I work directly with Veeva Systems through Upwork, managing complex healthcare datasets inside the Veeva Network ecosystem. My work ensures data accuracy, compliance, and clean record delivery for pharmaceutical clients with strict quality standards. Beyond Veeva, I bring 10+ years of experience in: - CRM data operations and validation - Data enrichment, cleaning, and QA - Lead generation and structured list building - AI-assisted research workflows - Web research and data verification - Excel and Google Sheets-based data management I am known for being highly reliable, detail-oriented, and easy to work with. Clients trust me with high-volume, high-stakes data tasks because I deliver consistent accuracy, clear communication, and strong process discipline. ⸻ CORE EXPERTISE - Healthcare Data Stewardship (Veeva Network) - HCP/HCO Record Management & Validation - Suspect Match Review & Duplicate Resolution - Data Enrichment & Quality Assurance - CRM Operations (Veeva, Salesforce) - Lead Generation & Research - Data Cleaning & Structured List Building - Excel & Google Sheets - AI-Assisted Research (ChatGPT, Claude, Gemini) - Web Research & Data Verification ⸻ TOOLS & PLATFORMS Veeva Network | Salesforce | Excel | Google Sheets | Asana | Trello | ClickUp | Notion | Slack | Zoho Desk | Zendesk | Freshdesk | ChatGPT | Claude | Gemini ⸻ WHY US CLIENTS HIRE ME - Top Rated Plus — top 3% of Upwork freelancers - 100% Job Success Score across all contracts - 6,000+ Upwork hours with strong long-term client relationships - Veeva Network experience — rare and in-demand skill - Fast learner, adaptable to new tools and workflows - High attention to detail with consistent, reliable output - Strong English communication and fast response time - Comfortable working independently or as part of a remote team If you need a dependable data specialist who can manage healthcare CRM data accurately, learn your systems quickly, and support your operations with professionalism — I'd love to connect.