Sophinat
Excellence in Preclinical and Medical Writing Services
19+ years of experience in rare diseases, oncology, and immunology.
Customized strategies ensuring precision and compliance.
Focused on clear communication and delivering results.
Who we are
About Us
As a preclinical consultant and medical writer with over 16 years of experience, I specialize in providing tailored solutions for pharmaceutical companies.
Whether you need support with regulatory writing, preclinical study design, or scientific documentation, my expertise ensures precision and compliance. Few understand the demands of preclinical research and regulatory writing like I do. I combine deep pharmaceutical industry expertise with practical solutions, empowering my clients to achieve groundbreaking results in rare diseases, oncology, and immunology.
I believe in delivering more than just results – I provide scientific rigor, clear communication, and a collaborative approach that drives innovation in niche fields.
Why Work with Me?
Helping businesses succeed is what we do.
More than a decade in leadership roles within international pharmaceutical companies.
Proficiency in rare diseases, oncology, immunology, and other specialized fields.
I prioritize scientific rigor and clear, concise communication in every project.
Every client is unique – so are my strategies.
office@sophinat.com
Curious about my journey?
Scientific excellence goes beyond knowledge and methodology. It’s about understanding people, building trust, and delivering results that truly matter.
What we offer
Bespoke Preclinical Consultancy and Medical Writing Services
At Sophinat, I specialize in delivering tailored solutions that bridge the gap between scientific complexity and practical implementation. My services are designed to support pharmaceutical companies, medical device manufacturers, and research organizations operating in highly regulated and niche fields.
1. Preclinical Consultancy
Preclinical research requires precision and expertise to meet regulatory and scientific standards.
2. Medical Writing Services
High-quality documentation is vital to the success of pharmaceutical projects
3. Quality Control and Review
Accuracy and compliance are non-negotiable in scientific documentation.
Choose your pakage
Flexible Pricing to Match Your Content Writing Needs
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/Package
- 5 Article
- 300 Word/Article
- 3 Days Delivery
- SEO Optimize
- 1 Keyword Featured
- Free 1 Article
Pellentesque suspendisse nisi parturient pretium tempor cubilia efficitur
/Package
- 5 Article
- 300 Word/Article
- 3 Days Delivery
- SEO Optimize
- 1 Keyword Featured
- Free 1 Article
Pellentesque suspendisse nisi parturient pretium tempor cubilia efficitur
/Package
- 5 Article
- 300 Word/Article
- 3 Days Delivery
- SEO Optimize
- 1 Keyword Featured
- Free 1 Article
Testimonial
Client Feedback & Reviews
Alexandra provides exceptional medical writing for nonclinical eCTD modules, delivering clear, precise, and regulatory-compliant content. Her expertise in gap analysis for nonclinical development programs ensures thorough assessments and strategic recommendations for streamlined submissions. Alexandra was always very proactive and addressed all queries in a timely manner making it a pleasure to work with her.
Alexandra Kopic collaborated with Hookipa Pharma as a consultant, serving as our Tierversuch Leiter for several years. She excelled in managing all communications with authorities and drafting permits, ensuring regulatory compliance. Her innovative and intelligent approaches significantly expanded our research scope by introducing diverse experimental methodologies, proving invaluable in advancing our studies and enhancing the understanding of Hookipa´s platform. I recommend Alexandra for any future opportunities with full confidence, as her exceptional skills and dedication make her an invaluable asset to any organization.
We greatly rely on Alexandra's/Sophinat's support in the conception, discussion, and drafting of proposals for highly regulated preclinical studies in pharmaceutical research projects. We have been closely collaborating with Alexandra for several years and are consistently impressed by her flexible work attitude, her ability to adapt to new content or changing legal frameworks, her highly professional and cooperative manner, quick turnaround times, and the consistently top-quality proposals she delivers.
We have been working very successfully with Sophinat for many years. Sophinat is an invaluable and indispensable partner, serving as a one-stop shop for preclinical development. Their vast expertise seamlessly integrates early research and pharmacology evaluations, nonclinical development, and the crafting of IND documents and publications. In addition to their outstanding proficiency, their flexibility and unwavering commitment have been tremendously beneficial to us.
Based on her broad experience and knowledge of the regulatory landscape to be adhered to in a GLP and GCLP environment, Alexandra generated successfully in a short period of time several types of reports (bioanalytical reports, development report, ISR report, Study Phase report) as well as prepared SOPs covering technical and scientific aspects for different devices and bioanalytical assays. Alexandra was able to accommodate to the predefined formats easily and provided timely and regular feedback. The team recognized Alexandra as a reliable person with excellent communication skills who delivered high quality documents.
Need help?
Let us know how we can help.
Ready to transform challenges into success stories? Let’s collaborate on preclinical consultancy and medical writing services designed for the pharmaceutical industry.
Common Question
Most Popular Questions
I offer bespoke preclinical consultancy, medical writing services, quality control and review, regulatory strategy, and project management. These services are tailored to meet the specific needs of pharmaceutical companies, medical device manufacturers, and research organizations.
I specialize in writing clear, accurate, and regulatory-compliant documentation, including clinical study reports, scientific publications, regulatory submissions, and technical documents. My writing ensures clarity and rigor, helping you communicate complex scientific data effectively.
I provide thorough quality control and review services, meticulously checking every detail of your documentation for scientific integrity, regulatory compliance, and clarity. This process helps eliminate errors and ensures that your documents meet the highest standards.
Preclinical consultancy ensures that your research aligns with regulatory requirements and scientific standards. I provide guidance on study design, protocol development, risk management, and regulatory strategies, helping you navigate complex regulatory landscapes and ensuring compliance at every stage.
I offer strategic regulatory support to help guide your research through global regulatory processes. Whether it’s IND submissions, orphan drug designations, or navigating regulatory requirements, my expertise helps streamline approvals and minimize potential roadblocks.
Yes, I provide full project management services, including coordination of timelines, resources, and teams. I ensure your preclinical research progresses smoothly and is completed on time and within budget, keeping all stakeholders aligned and focused.