your global support in Europe Over 20 years of experience ELM Pharmaceutica

Consultancy company established in 1995 and set up by a multidisciplinary active team of professionals with over 20 years of experience in bio-pharmaceutical industry. Provides services from early development, best regulatory strategy up to marketing and beyond to companies wishing to launch medicinal their products in EU market.

ELM has the required legal authorisation and organisation in-house to act as your EC company, saving initial unnecessary costs in a cost efficient and timely way. ELM Pharmaceutica

Development Dossier in European form Marketing authorization in UE Marketing Strategic application and tracking Price and reimbursement Registration dossier and European legislation Transfer/facilitati on companies: Import Distributor Manufacturer Pharmacovigilance Promotion control Clinical-preclinical trials/CMC studies Life cycle maintenance Manufacturing plant EU authorisation Advice, Coordinate, Manage, Facilitate: From Development to Marketing Internally Through companies and research centres

Multidisciplinary team having outstanding experience in: Business development Management and strategic consulting Clinical, non clinical, CMC and PhV requirements for final EU authorisation LATAM pharmaceutical market EU regulatory and legal activities through a regulatory website Regulatory policy HOW Our team: our strength Regulatory Pharmacovigilance Carla Besó + EU Development Jordi Ruiz External relations Latam Countries Xavi Perez Elisabeth Lopez Business strategy

 A long term detailed planning  Early definition of deliverable quality and efficacy criteria suitable for EMA/FDA approval  Large experience with EU regulatory agencies of drugs, medicinal food supplements and medical devices  Large experience in project coordination  Commitment to success  Connected to EU research and development centers  Large experience in EU national and transnational studies  Areas of expertise Life sciences (bio-pharmacy, veterinary science, cosmetics, nutrition, medical and environmental devices) Early detection kits development HOW: A strong network

Abbcn Developmen t of IVD ELM Pharmaceutica Development regulatory/ EU approval Method ex Lorien MAH Enoc Liposomal develop/ production Liposomed developments ELM lifescience: A strong network

Development studies We have contacts and experience with public Universities, Hospitals and private centres within Europe to perform clinical, preclinical, quality control analysis and characterisation of actives according to EU legislation in a cost efficient and timely way. A tailored made service that allows client to decide its degree of participation. Areas of activity: advice, coordination and managing

Regulatory activities Insight the company and through a regulatory web around Europe From due diligences of registration dossiers, manufacturing plant authorisation, European registration procedures (MRP, DCP, centralised or national), Marketing authorisation application, scientific advice meetings and other Agency contacts to price and reimbursment. Areas of activity: advice, coordination and managing

Pharmacovigilance Authorised by Spanish Agency and audited by our clients we can take over pharmacovigilance responsibilties, carrying out all pharmacovigilance activities in compliance with UE and in close relation with MAH requirements.

Business enhancing Identification of potential business partners from manufacturing transfer or import- batch release regulatorily necessary for commercialisation in EU, to distributors or wholesalers, licencees…..

From small start up companies to big pharmas wanting to enter EU market Our clients usa Local Responsible/MAH Due diligence Pharmacovigilance Bioequivalence Pharmaceutical development Bioequivalence studies monitoring and coordination Clinical metanalysis Scientific advices Medical writing Manufacturing plant EU authorisation Submission application Most of our clients are long term CNCE INNOVACION SL

Contact: ELM Farmacéutica Valencia 231, Ático 2ª Barcelona Phone: Fax: