Services
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.
With my medical background and deep scientific expertise, I quickly adapt to new therapeutic areas, ensuring that your project benefits from a fresh yet informed perspective.
1. Preclinical Consultancy
Preclinical research requires precision and expertise to meet regulatory and scientific standards. My consultancy services include:
- Comprehensive Study Design: Creating robust protocols for pharmacokinetics (PK), pharmacodynamics (PD), toxicology, and safety studies.
- Regulatory Guidance: Preparing animal use permits, ensuring compliance with regulatory requirements, and conducting gap analyses.
- Study Monitoring and Management: Overseeing studies to ensure efficiency and alignment with scientific goals.
Outcome:
Accelerated study timelines, minimized risks, and impactful research outcomes.
2. Medical Writing Services
High-quality documentation is vital to the success of pharmaceutical projects
- Regulatory Writing: Expertly crafted eCTD modules, Investigator Brochures, preclinical study reports, and briefing documents that meet global compliance standards.
- Scientific Publications: Manuscripts, abstracts, posters, and presentations tailored to engage academic and industry audiences.
- Educational Content: Clear and compelling training materials for healthcare professionals and AI-driven healthcare tools
- Business Communications: Precise meeting summaries, project reports, and professional presentations that deliver clarity and impact.
Outcome:
Documentation that builds trust with regulators, inspires stakeholders, and accelerates project success.
3. Quality Control and Review
Accuracy and compliance are non-negotiable in scientific documentation. My quality control
- Documentation that builds trust with regulators, inspires stakeholders, and accelerates project success.
- Error-free, publication-ready manuscripts.
- Alignment with global regulatory standards
Outcome:
Flawless documents that withstand regulatory scrutiny and foster stakeholder confidence.
Let’s Collaborate
Whether you need support with preclinical research, regulatory documentation, or scientific publications, I’m here to help. Together, we can achieve results that make a difference.
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