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B.Tech IT Professional and 12+ years of experience with Managed Services Providers (MSPs). Also, I have expertise on the following job roles and RMM, PSA, Remote, Backup, Antivirus and Documentation tools & applications: ConnectWise Automate | RMM | Manage | Control Helpdesk and NOC Support Service Controller PowerShell for Automation Microsoft 365 NinjaRMM Atera N-Central Kaseya Continuum Autotask ITGlue Passportal ITBoost ShadowProtect\ShadowXafe\ImageManager backups Acronis backups Webroot Antivirus SentinelOne Antivirus ESET Antivirus Cisco and ConnectWise certified and very familiar with Microsoft 365, PowerShell, VMware and Windows Servers environments. I understand the value of IT services.

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

Hello! I’m Nikhil Patil – Emerging Talent | Procurement & Supply Chain Specialist |Quality Control/Assurance Specialist With 8+ years of hands-on experience in Purchase Management, Cost Optimization, Vendor Management, and Strategic Sourcing, I bring a results-driven approach to global procurement. My academic foundation in Mechanical Engineering sharpens my problem-solving skills and enables me to manage complex supply chain dynamics with precision. 💼 What I Bring to the Table: Strategic Sourcing: Skilled in identifying reliable suppliers worldwide, ensuring quality, compliance, and competitive pricing. Supplier/Vendor Relationship Management: Proven ability to build and maintain strong partnerships for consistent performance and timely delivery. Cost Control & Profitability: Focused on reducing procurement costs without compromising quality or efficiency. End-to-End Supply Chain Management: From sourcing to final delivery, I ensure smooth operations and minimized disruptions. Effective Negotiation: Adept at negotiating favorable terms that result in significant cost savings and long-term value. 📊 Tools & Skills: Software Expertise: Microsoft Office Suite, Oracle-based ERP systems, and various procurement platforms. Data & Reporting: Advanced Excel & PowerPoint skills for detailed procurement analysis and reporting. AI Integration: Experienced in leveraging tools like ChatGPT and Perplexity AI for smarter, faster sourcing and procurement decisions. 🌍 Industries & Categories I've Handled: My diverse global portfolio spans a wide array of categories, including: Office Stationery Mechanical Machinery & Components NDT Testing DP (ASNT Level II certified) Steel & Plant Machinery Fabrication and Machining ( Steel) Plastic Mold & Mold Parts ( Toys , automobile parts , electronic parts etc ) Mechanical Equipment & Tools Apparel, Garments & Home Appliances 💡 Why Work With Me? I tailor each project to meet your specific procurement needs ,whether it’s sourcing, vendor negotiation, logistics coordination, or full-spectrum procurement support. My aim is always to go beyond expectations and build long-lasting partnerships based on transparency, performance, and value. 🕒 Availability: Available 40 hours/week for both short-term and long-term collaborations. 🌟 My Work Ethos: I live by the motto: "Going the Extra Mile." I believe in delivering results that not only meet but exceed expectations, creating win-win outcomes for every stakeholder involved.

I worked as a Electro-Mechanical Engineer/Regulatory Engineer/System Engineer/V&V Engineer/R&D Engineer/Technical Lead/Project Manager in the service industry for 11+ years. Domain Expertise: Medical, Industrial, and SEMI Skill set: Proof Of Concept design & Development and Possible solution & Feasibility analysis results. Global/Architectural Design, Layout, and Integration; System and Subsystem level requirements specification creation. Identifying inter-team Dependency, Test strategy plan creation, and Product risk assessment & Mitigation Concept development, Costing, Verification, and Selection Detail design, System integration, Design Verification, and Validation Material, finish & Manufacturing process selection, Structural and Thermal calculations Analyzing system Static & Transient Structural, Thermal, and Vibration behavior Electromechanical systems, Industrial and Medical Systems & Subsystem design Machining, Sheet metal and Extrusion products, Plastic parts (Injection mold, Urethane mold) design, and Plastic 3D printing (SLA and FDM) Human Factors Ergonomics design, Seismic analysis, Value Engineering, and Reverse Engineering PCBA mechanical Layout, Cable & Connector selections, Creepage and Clearance, ESD and RF Shielding Environmental Testing, Vibration Testing, Reliability Testing, IEC-xxxx Mechanical Testing, Bio Compatability, Sterilization and Cleaning RoHS, REACH, MDR, SWIXIT, BREXIT, China RoHS, Prop65 IEC 60601-1, IEC 61010, ISO 14971, ISO 13485

▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ WHO I AM ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ I am not a consultant who reads about pharma.I have lived it — on the shop floor. 16+ years inside pharmaceutical and nutraceutical manufacturing plants across India and Singapore —as a process engineer, industrial pharmacist, and formulation specialist — before bringing that expertiseto brands worldwide on Upwork. This means when I review your formula, compliance strategy, or manufacturing plan — I am speaking from direct hands-on experience, not textbook knowledge. I help supplement and pharma brands launch FDA & GMP compliant products — without the risks, recalls, and costly reformulations that come from working with consultants who only know theory. ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ⚕️ PHARMACEUTICAL FORMULATION ★ Core Expertise ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ▸ Tablet Formulation — Standard, Fast-Dissolving, Non-Effervescent, Chewable, Coated ▸ Capsule, Gummy, Softgel & Liquid Dosage Forms ▸ Lyophilization (Freeze-Drying) Protocol Development ▸ Peptide & Sterile Product Formulation ▸ Cosmetic & Personal Care Product Development ▸ Pilot Plant to Commercial Scale-Up ▸ Master Formula Records & Batch Manufacturing Records ◆ REAL CLIENT RESULT: A supplement company needed R&D support across Ayurvedic and diabetes product lines — ongoing research, formulation, and development support. → 1,501 hours of expert execution over 2+ years → Client: "Very experienced. We look forward to a long relationship as he helps us develop and scale our business." ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ 🧪 SUPPLEMENT FORMULATION ★ High Demand Specialty ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ▸ Vitamins, Minerals & Multivitamin Blends ▸ Probiotics, Prebiotics & Gut Health Formulas ▸ Sports Nutrition — Protein Powders, Pre-Workouts ▸ Herbal & Ayurvedic Supplement Development ▸ Gummy Supplement Formulation (Pectin & Gelatin) ▸ Private Label Compliance for Amazon & eRetailers ▸ Supplement Testing & Quality Specifications ◆ REAL CLIENT RESULT: A US brand needed a premium fast-dissolving tablet formulation — technically complex, non-effervescent. → Complete formulation system delivered in 10 days. → Client: "Very responsive and very good at his craft." ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ 📋 REGULATORY & COMPLIANCE ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ▸ FDA, GMP, ISO, HALAL Compliance Strategy ▸ Label Compliance & Health Claims Verification ▸ IND, NDA, BLA & CTD Regulatory Submissions ▸ CMC Strategy & Documentation ▸ Import-Export Consultation — Pharma & Supplements ▸ Amazon Private Label Regulatory Compliance ▸ Multivitamin Supplement Compliance (India & Global) ◆ REAL CLIENT RESULT: A brand needed label compliance review for health claims — fast turnaround required. → Delivered same day. → Client: "Professional, knowledgeable and pragmatic." ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ 🏭 MANUFACTURING & ENGINEERING ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ▸ Pharmaceutical Manufacturing Facility Consulting ▸ GMP Cleanroom Layout Design & Costing ▸ Equipment Qualification & Validation (IQ/OQ/PQ) ▸ Contract Manufacturing Connections Worldwide ▸ Offshore Pharma Manufacturing Setup Consulting ▸ Process Improvement & Troubleshooting ▸ Supplier & Manufacturer Identification ◆ REAL CLIENT RESULT: A US consultant helping a Caribbean country set upan offshore pharmaceutical manufacturing facility needed expert guidance. → 20 hours of precision consulting delivered. → 5-star review. Project completed on scope. ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ 🌍 GLOBAL CLIENTS I HAVE SERVED ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ USA × Europe × Caribbean × India × Singapore Supplement Brands × Pharma Startups × Medical Clinics Research Companies × Private Label Brands × Manufacturers ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ✦ WHY CLIENTS CHOOSE ME ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ✦ 16+ years on actual shop floor — not just consulting ✦ Dr. Reddy's Lab × Alkem Lab × Singapore MNC experience ✦ Approved Chemist License — Drug Controlling Authority ✦ Upwork Enterprise client trusted — Chemistry AI Models ✦ Long-term relationships — clients scale with me ✦ "Highly recommended" — multiple independent clients ✦ Fast turnaround — even on complex technical briefs ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ 🏆 MY NUMBERS ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ✦ 100% Job Success Score ✦ Top Rated Plus — Upwork's Highest Freelancer Badge ✦ $60K+ Earned × 73 Jobs × 2,583 Hours ✦ 26 Projects Currently In Progress ✦ Clients from USA, Europe, Caribbean, India, Singapore ✦ Approved Chemist — Government Licensed ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ 📩 LET'S WORK TOGETHER ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ Tell me your product, your challenge, your market. I will tell you exactly what needs to happen — and do it. First consultation call: FREE. Response time: 0–4 hours.

Most hardware startups hit the same wall: a great idea, a concept sketch, and no clear path to a working prototype. That's where I come in. I'm a mechanical engineer with 5+ years of R&D experience designing precision subsystems for some of the most demanding environments in manufacturing. I now bring that same engineering rigor to startups, researchers, and inventors who need real technical execution, not just advice. Here's what makes me different from most engineers on Upwork: I bridge hardware and software. I'm a full-stack developer too, and I use AI-assisted coding tools (Cursor) to build fast. If your product needs a sensor dashboard, a data pipeline, or an embedded control interface, I can build it alongside the hardware. I design AND build. I own 3D printers and fabricate physical prototypes in-house. You don't just get a CAD file, you can get a real part in your hands. I've shipped real products under real deadlines. My work has resulted in 30% cost reductions through DFM/DFA, cycle time improvements from minutes to seconds. What I work on: New product development: concept → CAD → simulation → prototype → manufacturable design FEA and CFD simulation: structural, thermal, vibration, and fluid analysis (ANSYS, MATLAB) 3D printing and rapid prototyping: functional parts optimized for your requirements DFM/DFA consulting: making designs producible, cost-effective, and reliable at scale Academic and research support: FEA, simulation, and technical writing for Masters and PhD projects Full-stack development: web apps, tools, and dashboards built around your engineering data Industries I serve: Robotics, medical devices, IoT hardware, consumer products, drones, UAVs, and academic research. I work best with clients who have a defined problem and want someone who can own the technical execution end-to-end. If that sounds like you, let's talk.