Established initially as a think-tank, today Prescriptia is an advisory firm focused on pharmaceutical research & development, RA strategies and Health economics. We deliver enduring solutions to various beneficiates – innovative and generic industry, CROs, law firms, authorities, academic and non-profit organizations

Prescriptia is registered as an Autonomous small-sized enterprise at the EMA’s SME register and is registered EudraVigilance user.

SERVICES

Health Economics and Pharmaco-economics

  • Cost-effectiveness and budget impact modeling
  • Dossier preparation for Health Technology Assessment (HTA) submissions
  • Value Added Medicines: Time to adjust the HTA Decision Frameworks for more patient-centric innovation – published on Sep, 5ht, 2017 by www.medicinesforeurope.com
  • Cost-effectiveness of evolocumab in treatment of HeFH in Bulgaria: Measuring health benefit by effectively-treated patient-years (ETPY) – published on ISPOR 19th European Meeting, May 20-24, 2017, Boston, MA, USA

Outcome Research

  • Epidemiological and observational studies
  • Patient surveys
  • Development and validation of patient-reported outcome measures
  • Qualitative research (patient interviews, focus groups)

Real World Evidence

  • Patients or Physician surveys
  • Prospective studies
  • Real world data identification and collection

Pharmacovigilance

  • Medical literature searches
  • E2B reporting via EMA’s WebTrader
  • MedDRA coding
  • Preparation for PhV audit and inspection
  • Risk Management plans

Regulatory Affairs

  • Regulatory Strategies and Liaison with Competent Authorities.
  • MRP/DCP strategies
  • Organization of EU-scientific advice meetings
  • Readability testing

Clinical Trials Development

  • Phase I-IV protocol development for various trials in dementia, T2DM, gynecology, osteoporosis and oncology

Product Lifecycle Management

  • Upgrade of dossiers, eCTD, handling variations – services provided for companies from any facet of the pharmaceutical industry
  • Trainings

Due Diligence

  • Advising dossier transfer/licensing in a number of successful deals

Why us?

What make Prescriptia different are their founders: people with high academic background, over 10 year’s previous international regulatory experience, working in dynamic, multi-lingual and high-technology dependent environment.