M E D I T E E M A  OY

Who we are

 

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.

We provide medical expertise

 

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)

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!

Mediteema in nutshell

Contact

 

Mediteema Oy

Hemmingintie 159

FI-37530 Lempäälä, Finland

 

CEO Ritva Ylitalo-Heikkala, MD, PhD, associate professor (docent) of pharmacology

tel: +358400568881

ritva.ylitalo-heikkala@mediteema.com