NORITNIELSEN COMPETENCIES

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1 About Us Regulatory Affairs Pharmacovigilance Medical Marketing ONE-STOP-SHOP We have all the relevant skills combined in one place, so your company does not need to coordinate between different providers. Market Access We are specialists dedicated to pharmaceuticals, medical equipment, dietary supplements and cosmetics. We have commercial insight, years of experience and local network in Scandinavia. Marketing NORITNIELSEN Sales COMPETENCIES Business Support We cover the following business areas: Regulatory Affairs, Pharmacovigilance, Medical Marketing, Marketing, Market Access, Sales and Business Support.

2 ABOUT NORITNIELSEN NoritNielsen was established in 2010, by Lisa Norit and Lisbeth Nielsen. Since then, more have joined and today nine people are affiliated with the company. We have our roots in Denmark, yet our competences are related with the Nordic countries. About Us The characteristics of NoritNielsen are specialist skills combined in one place. This ensures our customers a high level of professionalism. We have backgrounds as doctors, pharmacists, dentists or similar sciencebased educations. We cover areas such as pharmaceuticals, medical equipment, dietary supplements and cosmetics, as well as covering the Regulatory Affairs, Pharmacovigilance, Medical, Marketing, Market Access, Sales and Business Support. Our customers contact NoritNielsen when a need for specific skills arise, or during busy periods or vacancies. Moreover, we help new companies when establishing themselves in the Nordic market. Depending on the customer s need, we can work with ad hoc tasks or be temporarily connected to the company. WE COVER 25 THERAPEUTIC AREAS Andrology Anesthesia Anemia Cardiology Dermatology Endocrinology Gastroenterology Gynaecology Haematology Incontinence Infections medicine Infertility Immunosuppression Neurology Nephrology Odontology Oncology Orthopedic surgey Osteoporosis Pain treatment Psychiatry Rheumatology Transplantation Wound care Virology ONE-STOP-SHOP One-stop-shop signifies all competences combined in one place. We often work across different areas, and ensure back-up of our competencies if the situation demands it. WE HAVE WORKED FOR A LARGE NUMBER OF CLIENTS When working with NoritNielsen the company will experience a very simple and smooth communication flow. Whether it is a large or a small job, the company will only have one contact person who will ensure that the information is communicated to the right person. In addition, if a need for other competencies occurs, NoritNielsen will also solve this. NoritNielsen ensures coordination and follow-up on all assignments, as well as seeing the job through to completion and tensure hat the deadline is met. Abbott Almirall Alpha Sights Bayer Cephalon Pharma ApS Desitin Eurographic Farmisan Farmazan Forest Laboratories Nordics Gilead Green People Lundbeck Pharma A/S Nordic Drugs AB NordicInfu Care Nordisk Digital Emballage Norgine Novartis Novo Nordisk Scandinavia AB Peter Carlsen Interim Management Pfizer Pharmaforce RB Pharmaceuticals Reputation CPH Sanofi Pasteur MSD Sandoz

3 Regulatory Affairs Pharmaceuticals Consulting or completion of applications on marketing authorisation. Contact to the Danish Board of Health and other relevant authorities. Maintenance of registered pharmaceuticals, submission of variations and renewals. Preparation / translation of SPCs, package leaflets and labeling. Administrator or help with DKMAnet. Monitoring of pharmaceutical legislation. Preparation of reimbursement applications. Review of promotional material. Regulatory Affairs WE ENSURE RULES AND REGULATIONS ARE FULFILLED We ensure the regulatory strategy is updated in order for the company to maintain marketing authorisation and secure future business. We provide advice as to the understanding of regulatory requirements when pharmaceuticals or medical equipment are to be launched. As Regulatory Manager for ad hoc tasks, or temporarily connected to the company. Medical Equipment Consulting related to the preparation of technical files. Advice for classification and claims. Preparation of labeling. Registration of accredited body (Notified Body). Review of promotional material. Dietary Supplements Review and registration with relevant authorities in the Nordic countries. Product evaluation. Preparation of labeling. Advice in connection with claims. Review of promotional material. Cosmetic Review with relevant authorities. Product evaluation. Preparation of labeling. Advice in connection with claims. Review of promotional material.

4 Pharmaco vigilance WE ENSURE CORRECT PROCEDURES ARE FOLLOWED We ensure the development of procedures for handling side effects, recalls and more, thereby ensuring the company is in safe hands should the situation arise. We ensure internal procedures are up-to-date and comply with GDP requirements. As Pharmacovigilance Manager or QA Manager for ad hoc tasks, or temporarily connected to the company. Preparation of SOPs for side effect handling, recalls, literature searches etc. Preparation / submission of Periodic Safety Updates (PSURs). Literature searches. Contact to authorities. QA/GDP Application or renewal of business permits ( 39 application). Development, implementation and maintenance of a quality system. Preparation of SOPs / instructions on complaint handling, recalls, self-inspections etc. Help with GDP questions and correspondence to the Danish Board of Health. Pharmacovigilance

5 Medical Marketing WE ENSURE A PROFESSIONEL MEDICAL KNOWLEDGE We provide relevant scientific and medical knowledge for marketing / sales. We ensure current legislation and codes are followed. We ensure communication between Key Opinion Leaders and the company is at a high knowledge level when it is required. As Medical Manager or Medical Adviser for ad hoc tasks, or temporarily connected to the company. Scientific proofreading. Compliance (medical and legal review). Medical writing. Identification and evaluation of new products and therapy areas. Literature searches. A medical strategy. Evaluation of new study results / publications. Key Opinion Leader identification and contact for projects. Advisory Board. Documentation for a product s USPs. Establish a documentation platform for a product s USPs. Abbreviated summary of product characteristics. Development of marketing material based on scientific literature. Establishment of internal approval processes. Education in disease areas. Medical Marketing

6 Marketing WE COMMUNICATE We ensure market knowledge based on a qualitative market research. Versioning of foreign campaign material. Pre-launch plans. Marketing plans. Competitor analysis. Stakeholder mapping. Estimation of potential. Qualitative market research. Development of new marketing material. We ensure the strategy and prepare communication material in accordance with the research. We ensure the sales force is familiar with information about the market, therapeutic area, the product and competitors. As Marketing Manager or Product Manager for ad hoc tasks, or temporarily connected to the company. Marketing

7 Market Access WE ARE FOCUSED ON THE IMPORTANT BARRIERS IN THE MARKET We analyse and describe the decision flow within specific therapy areas. Strategic presentations addressing specific problems in the market. Documents required in the RADS process. Assistance with the preparation of reimbursement application. Assistance in creating treatment instructions. Pre-launch plans. Presentation of collaboration opportunities with patient associations. We identify key-decision-makers and people with great influence. We estimate the importance of key stakeholders, for example patient associations, RADS, the Scientific Society, IRF, The Reimbursement Committee amongst others. As Market Access Manager for ad hoc tasks, or temporarily connected to the company. Market Access

8 Sales Business Support WE SELL We contribute by ensuring that the direct customer contact will effectively contribute to successful sales. We ensure the sales representative is professional and technically skilled for a meeting with the customer. We ensure correct segmentation and analysis, which provides the right sales foundation. As Sales Manager, Key Account Manager or Sales Coordinator for ad hoc tasks, or temporarily connected to the company. Analysis and sales figures. Market segmentation. Preparation, implementation and monitoring of sales plans. Training in sales techniques. Sales coaching and co-driving in the field. Sales in the field. Support for Customer Relationship Management (CRM). WE COORDINATE We handle all activities supporting sales and marketing. We ensure a coordinated effort between sales, marketing, customers and external suppliers. We carry out Customer Relationship Management (CRM) tasks as well as perform back-office functions. As Marketing Coordinator for ad hoc tasks, or temporarily connected to the company. Setup and customising of reports. Medical proofreading. Translation of protocols, sales and marketing material. Customising and editing marketing material. Coordination between marketing and an external advertising agency. Approval of promotional material in the ZincMap program. Preparation and presentation of sales reports. Phoner assistance. Management of meetings, congresses and symposias. Sales Business Support

9 LISA NORIT Partner, cand.pharm., certified business coach info@noritnielsen.dk LISBETH K. NIELSEN Partner, doctor, MD info@noritnielsen.dk Skudehavnsvej Nordhavn - DK - CVR

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