English Svenska High quality services to the pharmaceutical and medical device industry in the Nordic countries: Regulatory Affairs incl. Quality GMP/GDP, Pharmacovigilance 24/7, Medical Writing, FASS.se/NPL and Nordic equiv., Pharmacokinetics. OUR SERVICES REGULATORY AFFAIRS PHARMACOVIGILANCE MEDICAL WRITING FASS.SE/NPL + NORDIC PHARMACOKINETICS The Company Staff / Contact Location About Us / FAQ Charity Vacancies / News Let us serve you! From left, top row: Anna, Maria S, Maria N H, Hanna, Linda, Eva, Anita, and Elin. From left, bottom row: Gunnar, Håkan, Mats, and Magnus. Malin, Elisabeth, David, and Adrian are not present. Picture is taken in front of the building at Bangårdsgatan 4A, which is our new office from January 2014. Read more on our extensive range of services below! A well-established company founded in 1996 with the advantages of a small company: Focus on customer needs Rapid turnaround time Flexibility Dedicated staff Easy communication Cost-effective organization Experienced Virtual Pharma partner Regulatory Affairs including Quality GMP/GDP – pharmaceuticals and medical devices Strategic and general regulatory consulting Review of documentation Writing of chemical pharmaceutical documentation Compilation and filing of dossier for MRP, DCP and CP – including electronic submissions Expert reports – pharmaceutical products and medical devices Readability tests of package leaflets – including design of tests, forms, interviews and tests of texts by volunteers, and final report SPCs, labelling and package leaflets, translations from/to English, and managing of Nordic translations Applications for clinical studies to regulatory bodies and ethical review boards in the Nordic countries Applications for registry and non-interventional studies to ethical review boards in the Nordic countries Variations and renewals Quality GMP/GDP functions: Acting as a Qualified Person Wholesale (Responsible Person) for Swedish companies, taking care of Product Complaint Handling, Product Recall, managing local/regional GDP inspections and audits, and supporting batch and product releases, etc. Cosmetics: Product Information File and Cosmetic Product Safety Report according to EU Cosmetic Directives and Notes Of Guidance Price applications to Swedish TLV including supporting documentation Quality Assurance Standard Operating Procedures for wholesale, pharmacovigilance and clinical trials Quality Control documentation QA review of reports Making audits and internal self-inspections Pharmacovigilance Drug Safety / PV service to customers Electronic reporting via Eudravigilance Web (EVWEB): Reporting of any appropriate safety cases to the health authorities via EVWEB Literature PV searches on a regular scheme Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc. Risk Management Plans for NDA:s Cooperation with customers to maintain their Pharmacovigilance Databases Standard Operating Procedures (SOPs): Designing all safety-relevant SOPs specifically for your company and in compliance with all Nordic and EU regulations and quality standards Qualified Person responsible for pharmacovigilance (QPPV) with 24-hour availability towards authority on behalf of our customers Medical Writing Clinical study protocol, including pharmacokinetics Clinical study report, including pharmacokinetics Investigator's Brochures IMPD (Europe) and IND (FDA) packages – also for FTIM (First Time in Man) studies Manuscripts for publication Literature reviews and PubMed (Medline) and other database searches Clinical and Pre-clinical Overviews and Summaries for New Drug Applications (NDAs) Medical Devices: Report on Biological Evaluation of Medical Devices (ISO 10993-1:2009) and Report on Clinical Evaluation (MEDDEV 2.7.1 Rev.3) FASS.se/NPL and other Nordic product texts Managing of product texts (catalogue, SPC and PIL) in the Swedish FASS.se system. We are Preferred Supplier by the Swedish Association of the Pharmaceutical Industry and have a Master Agreement for serving Swedish and foreign pharmaceutical companies with FASS.se. The service can include managing of the NPL (Nationellt Produktregister för Läkemedel; "National Product Register of Pharmaceuticals") database system for our clients. Handling of product texts (catalogue, SPC and PIL) also for Denmark, Norway and Finland Pharmacokinetics and bioequivalence, including interchangeability of generic products Evaluation of bioequivalence and pharmacokinetic documentation before a NDA Evaluation of the possibility for a generic product to be interchangeable with the market leading product Pharmacokinetic/bioequivalence calculations using WinNonlin™ at client's office PK Solutions™ is used in-house for pharmacokinetic/bioequivalence calculations of non-compartmental kinetics Toxicokinetic studies with evaluation using WinNonlin™ or PK Solutions™ and full report writing of pharmacokinetic part GLP approved for toxicokinetic studies by a major pharma company – can act as a principal investigator Basic biostatistics of pharmacokinetic data using Statistica® Pharm Assist Sweden AB Bangårdsgatan 4A, SE-753 20 Uppsala, Sweden Phone: +46-18-71 32 00, Fax: +46-18-71 32 04 © Pharm Assist Sweden AB 2003-2014