Founded in 2014, Revipharm is a consulting firm which provides guidance to pharmaceutical and Healthcare companies in the area of regulatory affairs and pharmacovigilance. We also provide related services, such as quality system implementation, business development and training. We have many years of experience of working with and in the pharmaceutical industry and other such industries (cosmetics, medical devices). Revipharm is your company’s multicultural partner with a global presence through our various partnerships within Europe. The company’s quality services and results forge solid and long-term relationships with its stakeholders.

1. Every challenge
gives us an
opportunity to
demonstrate
our capabilities
and excellence
The Company
WHO WE ARE
Founded in 2014, Revipharm is a consulting firm which provides guidance to pharmaceutical and Healthcare
companies in the area of regulatory affairs and pharmacovigilance. We also provide related services, such as quality
system implementation, business development and training.
We have many years of experience of working with and in the pharmaceutical industry and other such industries
(cosmetics, medical devices).
Revipharm is your company’s multicultural partner with
Europe. The company’s quality services and results forge solid and long
OUR VALUES
Our values are the foundation of our company. Our
values define who we are and how we work:
Dedication to our clients: Our management and
processes are aligned towards satisfying the needs of
our clients. We are dedicated t service excellence that
gains us client’s continuity.
Quality and excellence in our Performance
conduct our business with honesty and transparency to
achieve the utmost standards of quality for the services
we offer. We apply rigorous standards and
methodologies to our work- monitor
rapidly regulatory environment- above and beyond our
clients’ expectations.
Commitment: We are committed to our mission and to
our clients. Our commitment is a promise that we will
always perform to the highest of their expectation.
Adaptability: We work with flexibility to adapt to our
customers' needs in a constantly changing market.
Knowledge: We acquire knowledge in order to lead in
our field. We share our knowledge with our clients.
Every challenge
gives us an
opportunity to
demonstrate
our capabilities
and excellence
The Company
Revipharm is a consulting firm which provides guidance to pharmaceutical and Healthcare
companies in the area of regulatory affairs and pharmacovigilance. We also provide related services, such as quality
ness development and training.
We have many years of experience of working with and in the pharmaceutical industry and other such industries
is your company’s multicultural partner with a global presence through our various partnerships
Europe. The company’s quality services and results forge solid and long-term relationships with its stakeholders.
Our values are the foundation of our company. Our
values define who we are and how we work:
: Our management and
processes are aligned towards satisfying the needs of
our clients. We are dedicated t service excellence that
Quality and excellence in our Performance: We
conduct our business with honesty and transparency to
achieve the utmost standards of quality for the services
we offer. We apply rigorous standards and
monitoring the complex and
above and beyond our
: We are committed to our mission and to
our clients. Our commitment is a promise that we will
always perform to the highest of their expectation.
: We work with flexibility to adapt to our
customers' needs in a constantly changing market.
: We acquire knowledge in order to lead in
our field. We share our knowledge with our clients.
OUR MISSION
Revipharm aims to be the leading consultancy in Product Development, Regulatory
Affairs, Pharmacovigilance, and Business Development consultancy for Pharmaceutical
and Health Care Industry.
We aim to be recognized and accepted as an efficient, reliable and innovative company,
supporting its clients in achieving their goals. We offer to our clients a range of first
quality services with high added value.
OUR VISION
Our vision is to be relied upon as a key partner for success on an international
level, and to become a major collaborator in product life cycle management. We
will achieve this by delivering the highest quality services in an efficient and
timely fashion, and by building a strong relationship with our clients.
Active partners
to the
pharmaceutical
and healthcare
industry
Revipharm is a consulting firm which provides guidance to pharmaceutical and Healthcare
companies in the area of regulatory affairs and pharmacovigilance. We also provide related services, such as quality
We have many years of experience of working with and in the pharmaceutical industry and other such industries
our various partnerships within
relationships with its stakeholders.
leading consultancy in Product Development, Regulatory
Affairs, Pharmacovigilance, and Business Development consultancy for Pharmaceutical
We aim to be recognized and accepted as an efficient, reliable and innovative company,
porting its clients in achieving their goals. We offer to our clients a range of first-class
quality services with high added value.
Our vision is to be relied upon as a key partner for success on an international
o become a major collaborator in product life cycle management. We
will achieve this by delivering the highest quality services in an efficient and
timely fashion, and by building a strong relationship with our clients.
If you are interested in working with
Revipharm, either through
collaboration or by contracting us
to work for you, please contact us.
We would be happy to further
discuss your needs and provide
you with a free quotation.
Tel.: +34 653832010
Fax.: +34 960451601
Email: info@revipharm.es
Web: www.revipharm.es
Revipharm, either through
discuss your needs and provide

2. BENEFITS
- SEVERAL YEARS OF REGULATORY AND
PHARMACOVIGILANCE EXPERTISE
- WE FOCUS ON QUALITY AND TECHNICAL
EXPERTISE IN OUR DAILY WORK.
- OUR SERVICE CONCEPTS ARE FLEXIBLE
AND WE STRIVE TO MATCH YOUR NEEDS.
- WE WORK WITH REASONABLE BUDGETS.
- MEETING DEADLINES IS A PRIORITY FOR US.
Revipharm has expertise in providing a full range of
regulatory affair solutions.
MEDICINAL PRODUCTS FOR HUMAN AND VETERINARY USE
Advice on national and international legislation.
Preparation of applications for marketing
authorizations for National, Mutual Recognition,
Decentralized and Centralized procedures.
Preparation of variations, extensions, transfers of
ownership and renewals.
Preparation of dossier in NeeS format.
SmPC, PIL and labelling. Adaptation to QRD.
Readability test.
Design of artwork for primary and secondary
packaging.
Clinical and Non Clinical overviews and summaries
(Module 2).
Compilation of Modules 4 and 5.
Notification of prices to the Health Authorities.
Consultancy in promotion and advertising
regulations
Laboratory and facilities authorisation
Relationship with local Regulatory Authorities.
“We are known for
consistent quality and
timely performance”
REVIPHARM CAN SETUP AND MANAGE YOUR ENTIRE
PHARMACOVIGILANCE SYSTEM. THIS OPTION
ADDRESSES THE NEEDS OF COMPANIES LOOKING FOR
RELIABLE AND COST-EFFECTIVE DRUG SAFETY
SOLUTIONS.
PHARMACOVIGILANCE
European Qualified Person for Pharmacovigilance
(EU-QPPV)
European Economic Area (EEA) Qualified Person for
Pharmacovigilance (& deputy QPPV).
Establishment and maintenance of pharmacovigilance
systems.
Local Pharmacovigilance Representative
Local contact person for pharmacovigilance (24/7
service).
Communication point between the local authorities,
local healthcare professionals, patients, client’s sales
force and client’s Preparation of Standard Operating
Procedures (SOPs).
Pharmacovigilance System
Definition of pharmacovigilance and quality systems.
Design / critical review of the Client´s
pharmacovigilance system.
Preparation, maintenance and updating the
Pharmacovigilance System Master File (PSMF)
Literature Searches and Evaluations
Continuous literature searches and evaluations based
on active substances.
Weekly or monthly searches available.
Periodic Safety Update Reports (PSURs)
Compilation, medical review, and submission of PSURs, addenda, and
summary bridging reports.
Risk Management System
Preparation of Risk Management Plans (RMPs)
Training
Pharmacovigilance Training for pharmaceutical sales representatives and/or
company personnel
Pharmacovigilance Agreements
with Third Parties
Drafting, reviewing and updating
Safety Data Exchange
Agreements (SDEAs).
Establishment of clear
communication channels and
methods with partners.
QPPV SOLUTIONS
The Qualified Person for
Pharmacovigilance must be
continuously at the disposal of the
MAH and shall be experienced in
all aspects of pharmacovigilance.
This is usually a challenge for small
and medium sized companies –
Revipharm can provide your QPPV
REVIPHARM SOLUTIONS
Revipharm provides a broad
spectrum of drug safety services
tailored to the needs and
requirements of our clients. We help
manage the safety of the client’s
products with a regulatory-compliant
and best-practices approach
SDEA SOLUTIONS
A MAH rarely operates alone. It
has partners and use service
providers. Competent Authorities
expect to see pharmacovigilance
agreements between them that
clearly describe the responsibilities
for pharmacovigilance activities.
Our staff has years of experience

3. BENEFITS
• REVIPHARM ENSURES THAT YOUR
PROJECTS WILL BE COMPLETED TO
THE HIGHEST QUALITY STANDARDS,
ON TIME AND ON BUDGET.
• EFFICIENT REALISATION OF YOUR
REGULATORY PROJECTS.
• TARGET-ORIENTED ADVICE
• DECREASED WORKLOAD IN THE
AREA OF REGULATORY AFFAIRS.
• SUPPORT FOR COMMUNICATION
WITH HEALTH AUTHORITIES
COSMETICS
Preparation of Product Information File (PIF)
Preparation and maintenance of consumer
information and product labelling.
Notification procedures. Registration of products
Responsible Person
Request for Free Sale Certificates
Responding to consumer enquiries and regulatory
objections
Audits
Cosmetovigilance. Set up of a complete post-
marketing surveillance of Serious Undesirable
Effects. Reporting of Serious Undesirable Effects
Cosmetic products safety assessment (safety report)
Preparation of data sheets on the toxicological
characteristics of cosmetic ingredients
FOOD SUPPLEMENTS
Notifications, registrations, and applications to
Health Authorities – preparations, submission, and
follow-up.
Food labelling - preparation, evaluation, translation,
and update.
Technical support on the conformity of the labelling,
composition and claims.
Claims according to regulation (EC) 1924/2006 art.
13 and 14 – compliance, documentation, and
submission.
Design and development of packaging material.
Marketing material – compliance, translation, and
update.
Request for Free Sale Certificates.
Audits.
• Phytovigilance.
flexible solutions for
your business needs
WE OFFER A WIDE RANGE OF SERVICES AND
SUPPORT YOUR INTERNAL REGULATORY AFFAIRS
CAPACITY
MEDICAL DEVICES
Advice on current legislation in Spain and Europe.
Verification of compliance of the technical
documentation and the requirements for the
registration of medical devices in Spain and Europe.
Notification of medical devices To the Health
Authorities
Preparation of technical dossiers in order to obtain the
CE mark. Contacts with Notified Bodies and
consultancy for obtaining CE marking
Medical Device Vigilance in Spain
Assuming the role of Authorized Representative
Regulatory activities regarding the import/export of
medical devices
Translation and adaptation of the local labelling and
leaflet in compliance with the relevant requirements
Preparation of advertising material
• Request for Free Sale Certificates
HERBAL MEDICINAL PRODUCTS
Development and preparation of dossiers
Assistance with the licensing or registration procedure
Additional services, for example, readability testing, vigilance service.
MARKETING AUTHORISATION HOLDERS VALUE OUR
SPECIALIST KNOWLEDGE AND OUR MANY YEARS
OF EXPERIENCE
Revipharm can perform all of the
regulatory responsibilities for the
Pharmaceutical /Consumer
Healthcare markets on your behalf.
Revipharm has particular specialist
knowledge in the medicinal
product, medical device, cosmetics
and dietary supplement sectors.