Regulatory and Market Authorisation Services

Product – Mericon AS
Regulatory and Market Authorisation Services

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Contact Supplier: Mericon AS
Supplier Product: Regulatory and Market Authorisation Services
Address: Papirkaia 8, Klosterøya, P.O Box 2870, NO-3702 SKIEN, Norway
Tel: +47 35 90 85 40 / +47 90 06 64 55
Fax: +47 35 90 85 49
Website: www.mericon.no

Regulatory and Market Authorisation Services

Mericon offers regulatory and marketing authorisation services that cover the entire life cycle of products that include medicinal products for human and veterinary use, herbal medicinal products, medical device, functional food and cosmetics. Our expertise covers all steps in the process, from preparation of initial application to maintenance of the granted marketing authorisation.

Services
Mericon is an expert in all the process steps involved in bringing a medicinal product to the market, with services delivered by a highly educated team, fluent in English that combines experience in R&D within chemical, biochemical, pharmaceutical and pharmacological areas with detailed familiarity with regulatory protocols and requirements.

Mericon prides itself in delivering high quality, precise, reliable and cost-effective solutions, working to flexible patterns and to tight timelines. The company’s services are grouped under three main areas:

Regulatory Activities
Mericon can provide pharmaceutical, chemical and biotech companies with regulatory and marketing authorisation services for medicinal products.

The Mericon team combines its pharmacological, pharmaceutical, physiological, chemical and biochemical experience with mastery of detail, document production and regulatory requirements, to produce clear and accurate documentation to regulatory agencies. Mericon can provide client guidance on national and European MRP, DCP and CP procedures and requirements, assist in contacts with the Norwegian Medicines Agency (NoMA), act as lead contact for clarification of national issues in European procedures and as Norwegian agent for marketing authorisations and licence maintenance.

For Human and veterinary medicinal products, Mericon can also:

  • review and submit marketing authorisation applications to NoMA
  • translate and submit Norwegian product information (PI): summary of product characteristics (SPC),patient information leaflet (PIL)and labels
  • review and approve pre-print drafts of packaging materials
  • maintain marketing authorisations via variations, renewals, etc.
  • perform Norwegian readability testing of patient information leaflet
  • prepare and review summary of clinical documentation
  • collate and submit Norwegian Risk Minimisation Plan (RMP) materials
  • produce and maintain texts for the Norwegian Pharmaceutical Compendium (Felleskatalogen)

For traditional herbal medicinal products, Mericon can perform a similar range of services that include NoMA submissions, product information and marketing authorisation maintenance.

Marketing Activities
Mericon can assist clients with their marketing activities and campaigns, offering a suite of review and translation services. These include review and translation of all types of promotional materials, such as short product information texts, web sites, invitations, e-mail newsletters, presentations and information packs for medicinal products, herbal medicines and cosmetics.

For medicinal products and herbal medicinal products, Mericon can:

  • review marketing materials for consistency with Norwegian regulations and laws
  • translate marketing material into Norwegian
  • submit marketing material to the Committee for Information on Medicinal Product (CIMP) in Norway,who is acting on behalf of NoMA

These marketing services can also be applied to medical devices and apparatus, as well as cosmetics.

Pharmaceutical Wholesaling Services
Mericon can support pharmaceutical wholesalers with a range of marketing expertise that includes a Good Distribution Practice (GDP) service that:

  • produces guidance according to national/European requirements
  • provides support to applications for wholesale distribution authorisation

Features and Benefits
All Mericon services are carefully structured and designed to offer clients a range of important features and benefits.

Client Confidentiality
Mericon maintains absolute confidentiality and security on all client data.

Individually Tailored Services
Meicon offer an individual service adapted to the needs of the client. Our aim is that every client is satisfied with our services. Good human relationship is important for us.

Collaboration
Mericon is part of a European network of consultants (EuDRAcon: www.eudracon.biz), extending the range of services and solutions it can offer, as well as the markets it can address.

For more information about Mericon’s Regulatory and Marketing Authorisation services please contact Mericon AS directly.

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