your global support in europe over 20 years of experience elm pharmaceutica
TRANSCRIPT
your global support in EuropeOver 20 years of experience
ELM Pharmaceutica
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
MarketingStrategic
application and tracking
Price and reimbursement
Registration dossier and European legislation
Transfer/facilitation
companies:Import
Distributor Manufacturer
PharmacovigilancePromotion 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
AbbcnDevelopment of IVD
ELM PharmaceuticaDevelopment regulatory/ EU approval
Methodex
Lorien
MAHEnoc
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/MAHDue diligencePharmacovigilanceBioequivalencePharmaceutical developmentBioequivalence studies monitoring and coordination Clinical metanalysisScientific advicesMedical writingManufacturing plant EU authorisationSubmission application
Most of our clients are long term
CNCE INNOVACION SL
Contact:
ELM Farmacéutica
Valencia 231, Ático 2ª
08007 Barcelona
Phone: 932152006
Fax: 934677147
Email: [email protected]