Mediteema Oy is a Finnish company whose experts are physicians, experts in pharmacology, experts in the pharmaceutical industry.
Since 2005, we have provided high-quality medical expert services to our clients. We treat every client and every job -- new or old, small or large -- as unique and important!
We are doctors and experts in pharmacology, and have a long and comprehensive experience in the field of pharmaceutical industry and medical devices.
We provide medical, clinical and non-clinical expert services to pharmaceutical companies, medical device companies, and CROs and other service providers and organizations in this field.
For pharmaceutical products:
- Clinical and non-clinical expertise for marketing authorisation, variation and renewal applications (e.g., Modules 2.3, 2.4, 2.5 and 2.6, Addendum to Clinical Overview, other expert statements)
- Clinical expert statements for OTC applications
- Clinical sections of the SPCs and PLs
- Medical review of marketing materials
- Medical review of translations
For DRUG SAFETY:
- Medical evaluations and quality checks of individual safety case reports (ICSRs)
- MedDra terms and codings
- National and international literature searches (incl. weekly national and international searches)
- Periodic safety update reports (PSURs)
- Signal detections and benefit-risk assessments
- Risk management plans (RMPs)
- Other safety related pharmacovigilance documents (e.g., Addendum to Clinical Overview)
For medical devices:
- Clinical Evaluation Reports (CERs)
- Clinical Evaluation Plan (CEPs)
- Biological evaluations
- Literature searches
- Medical evaluation and coding of incident and adverse reaction reports
- Risk assessments and other documents, plans and reports related to postmarketing surveillance (e.g., PMS Plan, PMS Report, PMCF Plan, PMCF Report, PSUR)
FI-37530 Lempäälä, Finland
CEO Ritva Ylitalo-Heikkala, MD, PhD, associate professor (docent) of pharmacology