Lokelma (sodium zirconium cyclosilicate) for the Treatment of Adults with Hyperkalaemia
Lokelma is an oral suspension of sodium zirconium cyclosilicate that is indicated for the treatment of patients with hyperkalaemia.
MERICON
Research and Development Services for Clinical Studies and Regulatory Affairs
Papirkaia 8, Klosterøya, PO Box 2870, NO-3702 Skien,Other, Norway
MERICON, established in 1990, offers assistance within research and development to clinical studies and regulatory affairs.
All of MERICON’s scientific staff are educated at Norwegian universities. We have experience in research and lecturing from universities in Norway and abroad. We have several years of experience from research and development within chemical and pharmaceutical industries. In addition, we have experience in consulting for governmental authorities.
Services for pharmaceutical research and development and governmental health authorities
MERICON offers services to the pharmaceutical industry, governmental authorities and universities.
Within pharmaceutical research and development, we are specialised in registration and clinical testing of new medicinal products with respect to efficacy and safety. We prepare registration documentation and planning, monitoring and reporting of clinical studies.
MERICON
For governmental health and environmental authorities we give assistance with evaluation and reviewing of documentation.
We lecture at universities and give courses and seminars within our disciplines.
Regulatory affairs management for the pharmaceutical industry
MERICON has many years’ experience in assisting pharmaceutical industry in regulatory affairs management. We can offer assistance at all levels of regulatory affairs management.
Regulatory affairs services
Our regulatory affairs services include:
- Assisting in contact with the Norwegian Medicines Agency (NoMA)
- Providing guidance according to national procedures and requirements
- Preparing documentation for common technical document (CTD)
- Translating summary of product characteristics (SPC), patient information leaflet (PIL), labelling and other relevant documents related to marketing authorisation
- Readability testing of package leaflet
- Assistance regarding submission of variation to NoMA
- Preparing and updating product information in the Norwegian Pharmaceutical Product Compendium (Felleskatalogen™)
- Ensuring health and public marketing information is provided according to Norwegian law
Quality assurance of pharmaceutical ingredients
MERICON has experience within quality assurance in connection with manufacturing of pharmaceutical ingredients according to GMP.
Personalised services for clinical studies
The clinical product development process has become a complex orchestration of individual researchers, commercial sponsors, technology providers, regulatory agencies and patient consumers. Successful outcomes are largely dependent on how people and organisations work together.
We offer a personalised service from a small team, adaptable to client requirements and with a focus on quality and scientific standards meeting the international and national requirements.
Clinical research services
Our clinical research services include:
- Product development planning
- Protocol design
- Preparation for regulatory authority and ethics committee notifications
- Case report form (CRF) design
- Monitoring
- Report writing
Statistics and data management for clinical trials
We have a solid foundation of knowledge in medical science and statistics, as well as extensive practical experience in clinical studies. Our statistical services include:
- Sample size estimation
- Statistical analysis plan
- Randomisation
- Data management
- Statistical analysis
- Statistical report
- Pharmacokinetic calculations
Symdeko (tezacaftor/ivacaftor and ivacaftor) for the Treatment of Cystic Fibrosis
Symdeko™ (tezacaftor/ivacaftor and ivacaftor) is a combination drug indicated for the treatment of cystic fibrosis (CF) in people aged 12 years and above.
Faslodex (fulvestrant) for the Treatment of Advanced Breast Cancer
Faslodex (fulvestrant) is an oestrogen receptor antagonist indicated for the treatment of locally advanced or metastatic breast cancer.
Bavencio (avelumab) for the Treatment of Metastatic Merkel Cell Carcinoma
Bavencio® (avelumab) is a human PD-L1 monoclonal antibody indicated for the treatment of metastatic Merkel-cell carcinoma (MCC).
Eskata (hydrogen peroxide) for the Treatment of Raised Seborrheic Keratoses (SK)
Developed by Aclaris Therapeutics, Eskata™ (hydrogen peroxide) is an approved, topical, non-invasive treatment for raised seborrheic keratosis (SK).
Duzallo (allopurinol and lesinurad) for the Treatment of Hyperuricemia Associated with Gout
Duzallo (allopurinol and lesinurad) is indicated for the treatment of hyperuricemia associated with uncontrolled gout. It contains urate transporter-1 (URAT-1) inhibitor blended with xanthine oxidase inhibitor (XOI).
Truxima (rituximab) for the Treatment of Cancer
ruxima™ (rituximab) is the first biosimilar monoclonal antibody (mAb) approved for the treatment of haematological cancers, including diffuse large B-cell lymphoma, follicular lymphoma, chronic lymphocytic leukaemia, and rheumatoid arthritis, as well as granulomatosis with polyangiitis and microscopic polyangiitis.
Radicava (edaravone) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
Radicava™ (edaravone) is a neuroprotective agent indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Alecensa (alectinib) for the Treatment of ALK-positive Non-small Cell Lung Cancer (NSCLC)
Alecensa (alectinib) is a kinase inhibitor intended for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Exondys 51 (eteplirsen) for the Treatment of Duchenne Muscular Dystrophy (DMD)
Exondys 51 (eteplirsen) is an injectable solution developed by Sarepta Therapeutics.
MERICON
Papirkaia 8, Klosterøya
PO Box 2870
NO-3702 Skien
Other
Norway