CoreMed Profile

CoreMed
Profile 2012
Regulatory and Development Strategy Consulting
Regulatory and Development Strategy Consulting
CoreMed Corporation, founded in 1998, is an established Regulatory and Drug Development Strategy consulting firm
in Japan. CoreMed's services are dedicated to helping pharmaceutical and biopharmaceutical companies efficiently
and expeditiously navigate the regulatory approval process from the early development stage to product registration
in Japan, United States, Europe and Asian countries. CoreMed is centrally based in Osaka, Japan, with offices in Tokyo,
Washington and Hong Kong, and has collaborators in the UK and Germany.
CoreMed's services include:
Development and Registration in:
Planning, Review and
Conduct Gap Analysis of:
<Japan>
<USA>
Providing a full range of regulatory
and clinical/nonclinical development
services including: regulatory strategic
planning, preclinical pharmacology/
pharmacokinetics/toxicology
assessment, clinical study design,
clinical compliance audits, review/
preparation of regulatory applications,
representation and/or liaison with
regulatory agencies, and expert witness
services
Acting as the United States agent (US
agent) for non-US pharmaceutical and
biotechnology companies developing
products in the US
•
Regulatory Strategy
•
CMC (Chemistry,
Manufacturing and
Controls)
•
Clinical Study
•
Nonclinical Study
Preparation and Review of
Regulatory Documents and
Reports
Preparation of, Presentation
for Regulatory Meetings
Conducting Feasibility study and
Gap Analysis on data packages and
registration strategies
Representation and/or
Liaison with Regulatory
Authorities
Performing R&D Due Diligence
for licensing-in/out products and
technologies
Expert Witness Testimony
Preparing a comprehensive set of CTD/
eCTD, from Module 1 to 5 for regulatory
submission
<Asia>
Information-gathering and analysis of
regulations and guidelines
Representation, contact, or liaison with
the competent authorities in each Asian
country
Representation, contact, or liaison with
the FDA
Preparation and submission of
regulatory documents, packages,
applications and reports
<Europe>
Assisting Non-European companies
to develop drugs from the early
develpment phase to clinical
development in the European region
Providing LR (Legal Representative)
services for CTA (Clinical Trial
Application) opening and management,
and QP (Qualified Person) services
including QP Audit when importing
investigational drugs into EU, including
QP audit
Preparation of integrated CTA
documents for clinical trials in EU
" Over the years, CoreMed has grown into one of the largest companies
offering high quality regulatory and drug registration consulting services."
Regulatory and Development Strategy Consulting
CoreMed Corporation
CoreMed's Consulting
Regulatory Strategy
Non Clinical Development Strategy
CoreMed is a major provider of strategic regulatory
consulting services in Japan, US, Europe and Asian
countries. We have a primary focus on regulatory
affairs and over the 10 years since our establishment,
we have been providing practical and strategic support
in designing regulatory strategies, analyzing the gap
between data and regulatory requirements, monitoring
and keeping up to date with international legislations
and pharmaceutical affairs laws and preparing all types
of regulatory documents and marketing approval
applications globally. CoreMed covers all stages of drug
development encompassing CMC, nonclinical and clinical
aspects.
CoreMed believes that the role of strategic preclinical
development will become increasingly important and we
can help our client have an early and intensive approach
to effective discussions with authorities including MHLWPMDA/FDA/EMA as this is one avenue to increase the
productivity of this drug development stage.
CoreMed does:
•
Design strategic regulatory planning integrating with
MHLW-PMDA/FDA/EMA requirements
•
Prepare, review, advise on and submit orphan
drug designation applications, CTN/CTA/IND, NDA
applications
•
Liaise between regulatory agencies and clients
•
Arrange, execute and prepare regulatory guidance
meetings with regulatory authorities
•
Investigate, analyze and report the most up-to-date
information on pharmaceutical and medical device
regulations and guidelines/guidances
•
Execute R&D Due Diligence and feasibility study
Chemistry, Manufacturing and Controls (CMC)
Our CMC team at CoreMed manages all regulatory
aspects of chemistry, manufacturing and controls and is
responsible for creating and implementing strategies to
support the entire development process from the early
development stage to regulatory approval.
CoreMed does:
•
Strategize technical and regulatory issues, identify
critical CMC regulatory issues and propose solutions,
•
Review and advise on CMC section of regulatory
dossiers and ensure high quality and timely regulatory
submissions of the CMC dossier,
•
Prepare CMC briefing papers for guidance meetings
with MHLW-PMDA/FDA/EMA and arrange/attend the
meetings,
CoreMed does:
•
Design, evaluate and analyze nonclinical development
strategies
•
Identify minimum nonclinical data requirements for
CTN/CTA/IND and NDA submission
•
•
Design and evaluate nonclinical study protocols
•
Arrange and prepare regulatory meetings with MHLWPMDA/FDA/EMA
•
Prepare and evaluate regulatory application dossiers
including Orphan Drug designation, CTN/CTA/IND, and
CTD/eCTD.
Select, evaluate, monitor and conduct QA audit of
contract research laboratories for each study
Clinical Development Strategy
To reduce the time to NDA submission and minimize risks,
it is important to have a well-defined and well-designed
clinical development strategy and to be familiar with the
Japanese regulatory requirements and the international
jurisdictions where the therapeutic is to be tested.
CoreMed does:
•
Design and identify clinical development strategy in
the early stage of product development phase
•
Design, write and advise on study protocols, clinical
trial reports and publications, CTN/CTA/IND application
dossiers and NDA dossiers including CTDs/eCTDs
•
Prepare, arrange, liaise and attend pre CTN/NDA
guidance meetings with regulatory agencies
•
Prepare briefing documents for orphan drug
consultation with MHLW-PMDA/FDA/EMA
•
Prepare and submit orphan drug designation
applications
•
Manage, control and audit clinical trials
Medical and Technical Writing
The quality of written scientific documents including CSRs,
CTDs/eCTDs for NDA submission i.e. CMC, nonclinical and
clinical modules presentations can play a critical role in the
success of product registration.
•
Contribute to the responses to inquiries from
regulatory authorities,
•
Provide input to our client’s CMC team to promote
global harmonization of specifications for drug
substances/products to the maximum possible.
•
CTN/CTA/IND/NDA package documents (Clinical
protocol, Investigator’s Brochure, Clinical Study
Reports)
•
Participate extensively in “due diligence” activities of
licensing and approval transfer.
•
Regulatory application dossier including NDA, Orphan
drug/device application
•
Briefing paper for guidance meetings with MHLWPMDA/FDA/EMA
CoreMed -E
CoreMed Corporation
Regulatory and Development Strategy Consulting
CoreMed's Project-Overlook
Regulatory Guidance
meetings with PMDA,
FDA, EMA
CTDs (Common Technical
Documents)
CoreMed evaluates and
prepares a fully integrated
CTD/eCTD from Module 1 to 5
in compliance with ICH and/or
regulatory guidelines of each
competent authorities.
CoreMed supports our clients
to establish and evaluate
strategy/tactics, reviews and
prepares briefing documents.
Our extensive experience leads
clients to successful outcomes.
Orphan Drug Designation
Japan has its own requirements
and procedures for designation
of an Orphan Drug Designation
(OD).
CoreMed, well aquainted with
OD processes, prepares and
submits OD applications and
guides clients to obtain OD.
CSR (Clinical Study Report)
Review and Preparation of
CSRs based on study protocols
and statistical analysis reports
in Japanese and English
Regulatory Documents
and Registration Dossiers
CoreMed prepares regulatory
documents and registration
dossiers:
•
European CTAs including
IMPDs
•
FDA Pre-IND, IND and NDA
filing dossiers
•
Clinical Trial applications
in Asian countries
Biologics
CoreMed, with extensive
experience in handling
biologics such as vaccines
and biotechnology products,
prepares, conducts gap
analysis on and reviews
regulatory documents for
clinical trials and product
registration.
Master File (MF)
registration for APIs
CoreMed prepares and
submits (Drug) Master File (MF)
application for APIs for nonJapanese manufacturers as an
In-country Caretaker.
CoreMed has extensive
experience in MF registration.
Foreign Manufacturer
Accreditation
CoreMed prepares and
submits Foreign Manufacturer
Accreditation applications to
the Japanese Authorities for
non-Japanese companies.
Raw and intemediate drug
substances
CoreMed provides a
comprehensive range of
consulting services on
manufacturing bulk/raw
and intermediate drug
materials including contract
manufacturing in collaboration
with Mitsui Co. Ltd.
The FDA requests a non-US
sponsor to appoint a US
agent when the sponsor
conducts clinical trials ,imports
investigational drugs, and
registers FDA's regulated
products in the US. The
US agent also acts as a
communication link between
the FDA and the foreign
company for communications.
CoreMed America, LLC is
experienced in providing
such services as the US Agent
for both drugs and medical
devices to non-US based
companies.
Legal Representative (LR)
CoreMed provides LR services
in collaboration with Verius
Limted (UK) in Europe.
Verius, contemplated and
regulated by EC Directive,
plays the role of a sponsor
representative for European
clinical trials including
notification of clinical
trials, signing regulatory
documents for clinical trials,
reporting SUSARs, submitting
annual safety reports, and
co-ordination with local
authorities for investigator
on-site inspections.
Clinical Deveipment in
Europe
In-Country Caretaker (ICC)
for Clinical Trials in Japan
Liaison with the Japanese
regulatory authorities as ICC
for opening and maintaining
CTN (Clinical Trial Notification)
on behalf of non-Japanese
companies in compliance with
GCP.
US Agent (Unites States
agent)
Qualified Person (QP)
CoreMed provides a QP services in collaboration with Biotec
Services International (UK). A QP is required to release supplies
of IMPs that have been manufactured outside the EU for use in
European clinical studies. As required, our QPs will conduct audits
of manufacturing facilities & ensure that each manufacturing batch
has been manufactured in accordance with cGMP guidelines.
CoreMed provides Clinical
Development services
in collaboration with
Harrison Clinical Research
Deutschland GmbH (HCR).
HCR, established in 1987 in
Munich, has been providing
with a complete range of
contract clinical research
services in Europe.
CoreMed-E
CoreMed Corporation Regulatory and Development Strategy Consulting
About CoreMed Corporation
Foundation:
March 16, 1998　Headquarters: Tsunenari Bldg.
2-1-21, Kitahama, Chuo-ku
Osaka 541-0041, Japan
(TEL）+81-(0)6-6221-1352 (FAX) +81-(0)6-6221-1357
Tokyo office:
KN Nihonbashi Bldg.
4-8-17, Nihonbashi-Honcho, Chuo-ku
Tokyo 103-0023, Japan
(TEL) +81-(0)3-5205-2757 (FAX) +81-(0)3-5205-2758
US office:
2111 Wilson Blvd., Suite 600
Arlington, VA 22201, U.S.A.
(Cell) +1-347-225-5264
(TEL) +1-703-351-5034 (FAX) +1-703-351-9292
Board Directors:
Toshinori Ochi, President and CEO
Masami Tamura, Executive Vice President and COO
Yasuhiro Maeda, Absentee Director
Departments:
Regulatory Affairs
CMC
Nonclinical Development
Clinical Development
Strategy Planning
Senior Regulatory Advisor:
Toshiki Hirai, M. Pharm.
former Head of Evaluation and Licensing Division
Pharmaceutical and Food Safety Bureau, MHLW
C o r e M e d
Affiliated Companies:
CoreMed America, LLC
2111 Wislon Blvd., STE 600
Arlington, VA 22201, U.S.A.
(Cell) +1-703-283-7661
(Tel) +1-703-351-5034
(Fax) +1-703-351-9292
Regulatorix Asia Inc.
Floor-21, New World Tower1, 18
Queen's Road Center
Hong Kong
(Tel) +852-2143-7544
(Fax) +852-2143-3650
A Member of the following
Associations:
OPMA (Osaka Pharmaceutical
Manufacturers Association)
TOPRA (The Organisation for
Professionals in Regulatory Affairs)
RAPS (Regulatory Affairs Professionals
Society)
DIA (Drug Information Association)
Medical Advisors:
Tohru Masaoka, MD
former Head of Osaka Adult Disease Center Hospital
Akira Miyake, MD
former Associate Professor of Obstetrics and Gynecology
Osaka University Hospital
CoreMed's consulting services:
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•
•
•
•
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Regulatory
Strategic Clinical & Nonclinical Development
CMC
Strategic product registration
Regulatory documentation
Product development consultation in Japan, US, EU and Asian countries
Contact:
Masami Tamura　mtamura@coremed.co.jp
+81-(0)6-6221-1352
www.coremed.co.jp
CoreMed -E