Hire the Best Pharmaceutical Industry Specialists
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I help biotech startups, pharmaceutical companies, and research sites navigate the complexities of clinical trial operations, regulatory compliance, and site management. With experience in both the hospital research setting and the pharmaceutical industry, I specialize in regulatory documentation, IRB submissions, and end-to-end clinical trial execution. From study startup to closeout, I ensure compliance with FDA and ICH-GCP regulations, facilitate seamless collaboration between sponsors and sites, and optimize workflows to keep trials on track. As an independent consultant, I provide high-level regulatory and clinical trial support without the overhead of a full-time team, helping sponsors and sites streamline processes, maintain compliance, and successfully execute clinical trials from initiation to completion. SERVICES I OFFER REGULATORY & IRB SUBMISSIONS ✔️ Preparation and management of IRB submissions, protocol amendments, and informed consent forms ✔️ Regulatory document management and compliance oversight for clinical trials ✔️ Good Clinical Practice (GCP) compliance training and regulatory support for investigators and research teams CLINICAL TRIAL MANAGEMENT & OPERATIONS ✔️ Oversight of clinical trial activities from startup to closeout, ensuring compliance with regulatory requirements ✔️ Coordination of site regulatory documentation, essential document tracking, and audit readiness ✔️ Study feasibility assessments, site selection, and ongoing trial monitoring support FDA SUBMISSION SUPPORT & COMPLIANCE ✔️ Support for IND, IDE, and Pre-IND submission document preparation and review ✔️ Regulatory compliance consulting for FDA, ICH-GCP, and 21 CFR Part 11 requirements ✔️ Coordination of regulatory correspondence and submission strategy for clinical development programs DATA MANAGEMENT & MEDICAL WRITING ✔️ Case Report Form (CRF) development and electronic data capture (EDC) system support ✔️ Medical writing for clinical study documents, including protocols, investigator brochures, and study reports ✔️ Adverse event (AE/SAE) reporting support and regulatory compliance guidance 🔍 SKILLS & SERVICES Clinical Research, Clinical Trial Management, Regulatory Consultant, IRB Submission, FDA Submission Support, GCP Compliance, Site Regulatory Oversight, Clinical Trial Operations, Clinical Study Document Review, Investigator Training, Research Compliance, IND/IDE Submissions, 21 CFR Compliance, Medical Writing, Adverse Event Reporting, Study Feasibility, Site Selection, Audit Readiness Let’s connect! If you need expert support in clinical trial execution, regulatory compliance, or FDA submissions, I would love to hear from you.

I bring an amazing combination of pharmaceutical expertise, medical writing experience, and marketing strategy to the table to help companies just like yours communicate complicated health, wellness, and scientific information with accuracy, clarity, and maximum impact. With over 26 years under my belt as a Registered Pharmacy Technician, a Bachelor’s Degree in Sales and Marketing, and over a decade of professional writing experience, I bring both clinical knowledge and business insight to every single project that I take on, whether it’s health and wellness blog posts, medical content, client-facing marketing materials, or research-backed educational resources. Are you looking for a content writer and strategist who understands both the science behind your message and the audience you need to reach? That’s where I come in! Throughout my career, I’ve worked with leading pharmaceutical companies, attended pharmaceutical advisory boards, collaborated with healthcare professionals to ensure scientific accuracy, and written for national health and fitness publications. I’ve completed the Diabetes Educator Training Course and hold a diploma in editing from the University of Waterloo, ensuring every piece I deliver is polished, precise, and fully credible. I have even competed in two regional natural bodybuilding competitions, giving me an inside view into the world of health, fitness, and supplementation. From medical articles, e-books, white papers, and website content to business emails, sales pages, and patient education materials, I create clear and engaging content that supports both your business goals and your audience needs. My marketing background allows me to develop messaging that not only informs but also connects and converts. Please feel free to check out my portfolio website at inkrxsolution. com If you’re ready to create high-quality content that blends scientific expertise with strong marketing strategy, I’d love to connect! Send me a message today and let's get started on your next project tomorrow. Looking forward to speaking with you!

ABOUT ME Regulatory documentation either moves your filing forward or it doesn't. I make sure it does. I'm a RAC-Drugs certified Regulatory Affairs consultant with 4+ years of hands-on experience supporting pharma, biotech, and medtech teams across FDA, EMA, Health Canada, CDSCO, and ICH frameworks. I deliver submission-ready documentation — not drafts that need rework. Most regulatory documents fail not because of bad science, but because they're poorly structured, inconsistently formatted, or not written to how reviewers actually think. That's the gap I close. What I Deliver: — IND/CTA and NDA/ANDA module drafting (Modules 2–5) — eCTD structure, publishing, and sequence preparation — Clinical writing: Protocols, IBs, CSRs, safety summaries — Labeling: USPI, SmPC, CCDS review and compliance — Regulatory gap analysis and audit readiness — SOPs, QA systems, CAPA documentation — Health Canada submissions and compliance strategy — MDR/IVDR: CERs, PERs, and technical file support Why Clients Choose Me: — RAC-Drugs certified — validated expertise, not self-declared — Top Rated Plus with 100% Job Success Score across all engagements — Structured, defensible documentation delivered on timeline — Direct, senior-level execution — no juniors, no handoffs — Built for lean teams and tight regulatory deadlines If your regulatory documentation needs to be submission-ready — not just technically complete — send me your project brief. I respond within hours and I don't deliver work that needs rework.

A pharmacist with over 6years experience in healthcare and pharmaceutical industry. Invested in carrying out research and in-depth analysis to provide evidence and insights that feeds healthcare decisions, pharma business output and regulatory decisions. Particularly skilled in secondary research on medical literature databases, clinical trial research, systematic literature reviews, medical writing, pharmacovigilance reports and project management. Over 5 years experience in medical writing: SLR reports, Clinical Evaluation Reports, Global value dossiers, manuscripts, HTA reports and clinical summaries. I am very efficient, organized and result oriented. I pay adequate attention to all my projects so deliverables are developed excellently and completed in a timely manner thanks to my years of research, medical writing and project management. Feel free to contact me if you require my services. I look forward to working with you.

Behind every exceptional customer experience, successful project, and high-performing team is someone making sure every detail is executed, every relationship is nurtured, and every process runs smoothly. That's where I do my best work. I am a Client Relationship Specialist, Project Coordinator, Executive Assistant, and Operations Professional with extensive experience supporting executives, business leaders, clients, and cross-functional teams in fast-paced, remote environments. My focus is simple: build strong relationships, keep projects moving, improve operational efficiency, and ensure clients receive a seamless experience from start to finish. I enjoy being the person who brings order to complexity. Whether I'm managing client accounts, coordinating projects, overseeing day-to-day operations, or supporting executive leadership, I create structure that allows teams to perform at their highest level while ensuring nothing falls through the cracks. Building lasting client relationships has been a constant throughout my career. I serve as a trusted point of contact, communicate proactively, resolve issues with empathy and professionalism, manage expectations, and follow through on commitments. I believe great customer experiences are built through responsiveness, attention to detail, and genuine relationship management, which naturally leads to higher client satisfaction, retention, and loyalty. As a Project Coordinator, I manage competing priorities with confidence by organizing timelines, coordinating meetings, tracking deliverables, documenting action items, facilitating communication across departments, and ensuring projects stay on schedule. I am comfortable collaborating with leadership, vendors, clients, and internal stakeholders while maintaining visibility on project progress from planning through completion. Operations is where I naturally thrive. I enjoy identifying inefficiencies, improving workflows, documenting processes, implementing standard operating procedures, and introducing systems that increase productivity and scalability. I adapt quickly to new technologies and enjoy learning tools that help teams work smarter. I have hands-on experience working with a wide range of business software, including Microsoft 365, Google Workspace, Slack, Microsoft Teams, Zoom, Asana, Trello, ClickUp, Notion, Airtable, Smartsheet, Calendly, DocuSign, Adobe Acrobat, Canva, QuickBooks, Xero, HubSpot CRM, Salesforce, Zoho CRM, Pipedrive, Zendesk, Freshdesk, Intercom, Jira, Confluence, SharePoint, Dropbox, Google Drive, OneDrive, ChatGPT, Microsoft Copilot, and AI-powered productivity tools. I quickly learn new platforms and integrate them into efficient day-to-day workflows. My experience includes executive calendar management, customer success, client onboarding, account coordination, CRM management, project planning, stakeholder communication, workflow optimization, process documentation, meeting coordination, travel management, inbox management, data management, reporting, administrative support, vendor coordination, contract administration, scheduling, customer support, issue resolution, and cross-functional collaboration. Colleagues know me as someone who remains calm under pressure, communicates clearly, takes initiative, and follows through. I enjoy solving problems before they become obstacles, balancing multiple priorities, and creating an environment where clients feel valued and teams can focus on delivering results. Whether supporting a startup, an established organization, or a growing remote team, my goal remains the same: strengthen client relationships, streamline operations, coordinate successful projects, and provide dependable support that helps people and businesses succeed. If you're looking for someone who combines strong relationship management, project coordination, operational excellence, and customer-first thinking with a proactive, dependable approach, I'd love the opportunity to contribute to your team. — Evangel

An experienced bookkeeper and US tax specialist proficient in financial operations and compliance. Has successfully managed bookkeeping and tax preparations for over 100 businesses, including small startups and larger enterprises. Expertise in accounting software like QuickBooks and Sage 50, specializing in full-charge bookkeeping, tax planning, and financial consulting. Core skills include bank reconciliation, financial reporting, and tax optimization, applied to deliver precise financial management and streamline tax processes effectively