September 10, 2025
Accurate. Compliant. Insightful. EvySaif partners with pharma, biotech, and device teams for scientific writing, regulatory submissions, HEOR, and medical affairs that stand up to regulators, payers, and peer review.
From first protocol to post-approval value, every deliverable is built by the same clinician-led team to the standards regulators, payers, and journals expect.
Economic models, systematic evidence, and value dossiers that make the case for access, reported to CHEERS 2022 and PRISMA 2020 and built for HTA, pricing, and reimbursement decisions.
Clinical and regulatory documents written to ICH standards, from trial protocols and CSRs to pharmacovigilance reports and submission summaries, accurate to the data and clear to the reviewer.
CE and CDSCO pathways handled end to end, clinical and performance evaluation, MDR and IVDR technical documentation, and post-market evidence that keeps your device compliant after launch.
Submission strategy, dossier preparation, and authority responses across the markets you sell in, with direct experience of Indian, US, European, and Gulf regulatory expectations.
Non-promotional scientific exchange delivered compliantly, from medical information and advisory boards to MSL enablement and medical review, as an extension of your own team.
EvySaif designs and builds decision analytic models end to end, from model structure and inputs to probabilistic sensitivity analysis and CHEERS 2022 compliant reporting, ready for journals, payers, and HTA bodies.
For short horizon comparisons, we structure the decision problem, assign pathway probabilities, and attach costs and outcomes to every terminal node.
For chronic and progressive disease, we build state transition models over lifetime horizons, with transition probabilities, cycle costs, and utilities for every health state.
Every input carries uncertainty. We run Monte Carlo simulations across full parameter distributions so decision makers can see how robust the result really is.
Every model is delivered with a full technical report, transparent assumptions, and sensitivity analyses that stand up to peer review and payer scrutiny.
Discuss your HEOR projectEvySaif supports medical device and IVD manufacturers end to end, from clinical evaluation and technical documentation to post-market surveillance, built to the expectations of EU notified bodies, the US FDA, and CDSCO reviewers alike.
We plan and write clinical evaluations to MDR Annex XIV and MEDDEV 2.7/1 Rev 4, from scope and state of the art to appraisal of every clinical data source. The same discipline carries into US FDA and CDSCO submissions.
We build and remediate technical documentation to MDR and IVDR Annex II and III, structured the way notified bodies expect to review it, with every claim traceable to evidence.
Approval is the start, not the finish. We run the post-market evidence cycle and feed it back into the clinical evaluation and risk file, keeping your documentation audit-ready for the device lifetime.
From first classification call to the latest PSUR, every document is written by the same clinician-led team, so your evidence tells one consistent story to any reviewer who opens the file.
Discuss your device pathwayWe help pharma, biotech, and healthcare teams turn complex science into credible, compliant, and impactful communication.
Every deliverable is built on validated evidence, transparent referencing, and strict adherence to global reporting guidelines.
Oncology, infectious diseases, cardiology, rare diseases, and metabolic disorders. We bring domain depth that shows in every document.
High quality graphics, infographics, and data visualizations that make complex science easy to grasp at a glance.
We translate complex data into clear, persuasive narratives that resonate with regulators, clinicians, and patients alike.
We work as an extension of your medical affairs team, with full ownership, reliability, and open communication at every step.
We understand pharma timelines and deliver with efficiency, consistency, and on-time execution, every single time.
Delivered work our clients can verify, not claims
First-in-human clinical trial protocols authored and approved
IVD performance evaluation files delivered for Indian and European markets
Peer-reviewed publications behind the writing, including first-author research
Oncology advisory board programs designed and delivered end to end
We partner with pharmaceutical and biotech companies, medical device and IVD manufacturers, CROs, and healthcare organizations across India, MENA, and Europe, from early-stage teams to established medical affairs departments.
Yes. Alongside the writing, we design publication-ready figures, infographics, slide decks, and data visualizations that make complex science easy to grasp at a glance.
Yes. Our expertise spans Oncology, Infectious Diseases, Cardiology, Metabolic Disorders, and more.
Every deliverable is built by clinician-led writers on validated evidence, with transparent referencing and adherence to ICH GCP, GPP 2022, and the relevant reporting guidelines, then passed through independent quality review before delivery.
Absolutely. We provide regulatory writing, scientific publications, medical affairs content, and educational materials.
Reach out through the contact page or email info@evysaif.com. We start with a short discovery call, scope the deliverable together, and share a proposal with timelines, typically within two business days.
September 10, 2025
September 10, 2025
September 10, 2025
July 18, 2026
July 18, 2026
July 18, 2026