IDIFARMA is a leading Contract Research and

Development Organization for the pharmaceutical

and biotechnology industries.
Based in Spain, and with an increasingly international
reach, IDIFARMA provides a full range of services
that encompasses: drug formulation, development
and validation of analytical methods, quality control
and batch release in the EU, Pilot-Scale GMPcompliant manufacturing, ICH stability studies, clinical
trial logistics management and regulatory support.
Our state-of-the-art facility features a purpose-built
high containment plant for the manufacturing of
GMP-compliant pilot batches in oral solid dosage
forms, for both conventional and high potency drugs.
Our experienced technical staff has developed
almost 100 generic and innovator drugs for our
clients, in different dosage forms (oral solids and
liquids, injectable, topical use, etc). We are specialized
in the development of high potency drugs (cytotoxics,
cytostatics, hormonals,...) and we have the capacity
to work with many different technologies: film coating,
spray drying, modified release, etc.
IDIFARMAs expertise, capabilities and proven
track record make us the perfect partner for the
development of your projects.

Pharmaceutical
Development
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Cofinanciado por:

Formulation and Analytical Development

Clinical Batches Manufacturing
Registration Dossier

Excipient compatibility studies

Pre-formulation and
formulation

Blinding strategies
management

Registration Dossier
Orphan Drug designation
application (EMA and FDA)

Placebo manufacturing
Labeling, primary and
secondary packaging

Release of final product to

be marketed in the European
Union

Manufacturing process design

Preparation of IMPD and

Investigators Brochure

Clinical trial application

Quality control and issuing

of analytical certificates for
raw materials, active
ingredients and finished
product

Selection of dosage form (oral

solids or liquids, injectables,
creams, ointments,
transdermal patches,)

Preparation, submission and

monitoring of applications
for Marketing Authorizations

Storage, shipment and

destruction of medication

Formulation
Development
Tech
Transfer

API
Selection

GMP
Compliant
Clinical batches
Manufacturing

Quality
Control and
Batch
Release

Stability
Studies

Clinical
Trial Logistics
Management

Clinical
Trials

Registration
Dossiers

Analytical
Development

SERVICES
PROVIDED
BY IDIFARMA

TECHNOLOGICAL SOLUTIONS
Development and validation
of analytical methods
Active substance and
reference product
characterization
Quality control and
validation of the
manufacturing process

Tablets and capsules

Film coating

Conventional or high
potency (cytotoxic,
hormonal, )

ICH Stability studies (Zones

I to IV)

Clinical trial placebo

manufacturing

In-use stability studies

Microtablets

Ongoing stability studies

Lyophilization

Manufacturing process
optimization at GMP facilities

Photostability studies

Modified release
Chewable, Orodispersible

Liposomes
Spray drying micro and nano encapsulation