Regulatory Affairs

Global Regulatory Expertise

Clinipace Worldwide offers you a team of multi-national Regulatory Affairs professionals who have vast experience working with competent regulatory authorities around the world. Our regulatory expertise ensures that regulatory strategies and alternatives are considered at every step to help you gain product registration, and include the following areas:

Regulatory Affairs

This team will work with you in both pre- and post-marketing drug safety regulations, document management, regulatory filings, global marketing authorization applications, variations and renewals and carefully developed due diligence strategies.

Our Regulatory Affairs services include:

Clinical Trial Applications and Product Registrations

Our experience encompasses US FDA and international clinical trial applications, and registrations of new chemical and biological entities, as well as those products containing established pharmaceutical ingredients (generics and 505(b)(2) products). We develop high-level regulatory strategies to expedite products through clinical trials and into the market, and regularly represent our clients in meetings with the US FDA and international regulatory authorities. Clinipace can act as the US agent for overseas companies.

Using mutual recognition or centralized procedures, we can manage the entire European registration process for new medicinal products as well as for generic products. We have extensive experience writing Drug Master Files for international product registrations.

Regulatory Publishing

Clinipace Regulatory Operations supports the production of submissions in both paper (“old” and CTD formats) and electronic formats. Whether you are submitting an original IND, NDA or ANDA, or an amendment, supplement, or variation to an existing application, or converting an existing application to eCTD format, we can publish and deliver an FDA/ICH-compliant submission to meet your needs.

In the ever changing world of regulatory submissions, we work with industry leaders to stay at the forefront of eCTD requirements. By using our own highly qualified and experienced staff to perform most of the e-publishing, and limiting the use of third party e-submission vendors to highly specialized activities, we can offer affordable e-submissions to our client companies, regardless of the size of their company. Our publishing team works closely with the authors to ensure documents are written using industry templates with the appropriate granularity, and to ensure formatting consistency across the dossier. Throughout all stages of submission preparation, consideration is given to the potential lifecycle management of the application to ensure that accommodations to future changes and amendments can be made with little or no disruption to the overall message of the application.

Clinipace Worldwide prepares all major regulatory submissions and provides extensive quality control review for all trial related documentation, such as:

Working as a collaborative team, our regulatory specialists coordinate all aspects of your trial's document collection and submissions, including:

Regulatory Writing

Our medical and technical writers prepare expert reports, summaries, investigator brochures, protocols and clinical study reports to meet regulatory authority requirements. Our team of experienced regulatory scientists can write the nonclinical, clinical and CMC sections in CTD and traditional format for your new drug and biologic applications. We have extensive experience writing Drug Master Files for international product registrations.

Legal Representation

Clinipace Worldwide regulatory consultants provide legal representation for clients in their interactions with competent authorities across the globe. Our consultants have represented clients and are authorized to act as their legal entity with the following authorities:

Argentina
Ministry of Health, National Administration of Drugs, Food & Medical Technology (ANMAT)

Austria
Austrian Agency for Health &
Food Safety

Australia
Therapeutic Goods
Administration (TGA)

Belgium
Federal Agency for Medicines
and Health Products

Brazil
Ministry of Health, National Health Surveillance Agency (Anvisa)

Bulgaria
Bulgarian Drug Agency

Canada
Health Canada, Health
Products & Food Branch

Czech Republic
State Institute for Drug
Control

Denmark
Danish National Board
of Health

Estonia
State Agency of Medicines

European Union
European Medicines Agency

Finland
Finnish Medicines Agency

France
French Agency for the Safety
of Health Products

Germany
Federal Institute for Drugs
& Medical Devices

Hungary
National Institute of
Pharmacy

Iceland
Icelandic Medicines
Control Agency

Ireland
Irish Medicines Board

Italy
Italian Medicines Agency

Israel
Ministry of Health

Latvia
State Agency of Medicines

Liechtenstein
Office of Health / Department
of Pharmaceuticals

Lithuania
State Medicines Control
Agency

Luxembourg
Ministry of Health

Netherlands
Medicines Evaluation Board

New Zealand
Ministry of Health

Norway
Norwegian Medicines Agency

Poland
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Portugal
National Authority of Medicines and Health Products

Romania
National Medicines Agency

Russia
Ministry of Health

Slovakia
State Institute for Drug Control

Slovenia
Agency for Medicinal Products
and Medical Devices of the Republic of Slovenia

Spain
Spanish Agency for Medicines
and Health Products

Sweden
Medical Products Agency

Switzerland
Swiss Medicines Regulatory Agency (Swissmedic)

United Kingdom
Medicines and Healthcare Products Regulatory Agency

United States
Food and Drug Administration (FDA)

News

Spectranetics chooses Clinipace for cardiovascular device clinical trial

Spectranetics has chosen Clinipace to manage all aspects of EXCImer Laser Randomized Controlled Study to treat FemoropopliTEal In-Stent Restenosis (EXCITE ISR). The study, which will serve as the basis for 510(k) notice submission, will enroll up to 353 patients across 30 sites in the US.

Regulus acquired by national firm

Boutique consulting firm Regulus Pharmaceutical Consulting Inc. in Boulder has been acquired by national clinical research firm Clinipace Worldwide. Terms of the deal were not disclosed. The Regulus team of approximately 15 people will remain in Boulder, said David Levin, a Clinipace spokesman.

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