As IDEAL Pharma Consulting we understand the critical importance
of complete and accurate regulatory submissions and collaborate on submission
planning and preparation. We perform in accordance with EMA (European Union)
and US-FDA guidelines critical writing and pre-submission reviews of key
technical documents to ensure consistency, scientific accuracy, completeness,
and regulatory compliance.
Marketing Authorisation o
Preparation of registration application dossiers in CTD format for
prescribed, non-prescribed and traditional herbal medicinal products for human
use as well as medical devices
o Preparation of GMP
inspection application dossiers
o Preparation of variation
application dossiers
o
SmPC& PIL preparation and updates
Expert Report Writing With more than fifteen years of experience, our team reviews your
documents, carries out the necessary literature searches and compiles
scientifically sound pharmacological/toxicological and clinical reports in CTD
format within a short time frame for your bibliographical submission with
challenging prices.
Our services are: o
Writing of pharmacological/toxicological reports in CTD format
o Writing of clinical
reports in CTD format
o
Updating of pharmaco-toxicological and clinical reports – including
phytopharmaceuticals – in the framework of re-submission procedures, including
Ø Pharmacological,
toxicological and clinical literature searches
Ø Procurement of relevant
original publications
Ø Preparation of documents
o
Periodic Safety Update Report (PSUR)
o Writing of expert
reports on selected pharmaceutical technical and regulatory issues
o Writing of scientific
and sector specific reports
o
English-Turkish translations
Our partner medical team is supported by a dedicated pharmacovigilance
group established to handle the processing of SAE reports to regulatory
authorities and investigators. In addition to pre-marketed safety reporting,
this group also provides post-marketing spontaneous adverse event reporting.
Our personnel have the training, education, and experience to provide a
comprehensive range of safety reporting services to meet the demands of SAE
reporting requirements of global drug, biologic, and device clinical programs
and post-market surveillance programs.
Meeting with the Turkish Regulatory Agency (TITCK) is a vital component to
a successful drug development program and requires deliberate strategy and
preparation. IDEAL Pharma Consulting is able to provide a wealth of
experience in dealing directly with the TITCK, requesting Scientific Advice and
liaising with Subject Matter Experts and Advisory Committees.
IDEAL Pharma Consulting can represent you in
the below given areas:
o
As a partner CRO located in Turkey as you have to have a Turkish partner
for conducting clinical trials
o
As a partner CRO for foreign CRO’s willing to operate in Turkey
o
As a marketing authorisation holder for companies which have no office in
Turkey
o IDEAL Pharma Consulting has the expertise to
devise successful regulatory strategies and to prepare or review relevant
regulatory documentation for the pharmaceutical, biotechnology, generic drugs
and medical device industries.
o
Additional services include assisting in compliance audits, licensing
activities, and regulatory training.
o
Our expertise in devising regulatory strategies is directed by senior staff
members who have many years of experience interacting with the Turkish Drug and
Medical Device Agency (TITCK).
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