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.

Partners

Pharma Consult

Training provider of high Quality courses based on the latest published technical and regulatory requirements.

Creativ Ceutical

Consulting in life sciences.

BioDome Clinical

Experts in Clinical Data Management and BioStatistics.

CONTACT INFO

28, Hristo Botev Blvd.

Floor 5

Sofia

BULGARIA

Tel.: (+359-2) 9434773

Fax: (+359-2) 9434225

E-Mail: office@prescriptia.com