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
- Funding breakthrough therapies: A systematic review and recommendation
- Low rates of patient-reported outcome claims for orphan drugs approved by the US Food and Drug Administration
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
CONTACT INFO
28, Hristo Botev Blvd.
Floor 5
Sofia
BULGARIA
Tel.: (+359-2) 9434773
Fax: (+359-2) 9434225
E-Mail: office@prescriptia.com