Regulatory Experts for Global Regulatory

Strategies and Solutions.

Your Global Partner in

Regulatory Affairs

Expertise in navigating through the dynamic Regulatory process.

Global Regulatory ChallengesEffective Regulatory strategies are critical to the successful pathway for product approval and commercialization of your product. The regulatory process, however, is a dynamic, evolving landscape. In addition, the increasing globalization of clinical trials requires the understanding and compliance to multiple and often diverse regulatory and operating standards. Knowing which regulatory agency to con-tact is not enough. Within this constantly changing and globally diverse regulatory environment, the need for experienced Regulatory staff is critical to the success of your product development.

TFS Global Strategists – Local Experts?TFS Regulatory Affairs Professionals are global strategists as well as local experts in country require-ments. Current with regulatory requirements, chang-es in legislation, and global submission standards, our experts have established, on-going relationships with local regulatory authorities. But more importantly, we know how to interpret and adapt regulations to support product approval and facilitate communi-cation with the appropriate Regulatory Authorities throughout the lifecycle of your product to avoid the common pharmaceutical submission hurdles and help expedite your product to market. Experience is a key factor and a must.

TFS Customized SolutionsTFS expert Regulatory Services include but are not limited to:

Clinical Studies• Global Scientific Advice• Data Safety Board – charter development; member-

ship definition; management• Clinical Development Plan• Preparation and submission of CTA/ITA, IND,

PMA/510(k)• Interaction with regulatory agencies world-wide• Orphan Drug Designations• Pediatric Investigational Plans (PIPs) & Pediatric

Study Plans (PSPs)• Country-specific documentation and submissions• End-of-trial declarations

Application of Marketing Authorization• Preparation and submission of marketing applica-

tions (CTD, NDA, BLA, NDS, MAA and equivalents)• Pediatric-use Marketing Authorization (PUMA)• Compilation of submission files- all procedures• Labeling proposal• Readability testing• Parallel import

Product Maintenance• SPC/product leaflet/labeling update• FASS editing• Variations

TFS Global Regulatory Affairs can lead a project from proof of concept to commercialization or we can provide individual services. We can serve as your primary Regulatory Agent or assist and train your personnel.

We provide dossier/submission compilation to all Regulatory Authorities. We can reformat your dossier/ submission in eCTD or CTD format and submit to any regulatory authority worldwide including but not limited to the FDA, Health Canada, EMA, etc. And, when it comes time for that particular and delicate regulatory submission, we will be able to show you that “your submission” is “our submission”.

Whatever your require-ments, you can be confident that TFS has the regulatory staff and expertise to help you achieve a positive outcome.

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Regulatory expertise from proof of concept to commercialization.

CONTACT US for a meeting!TFS Global HQ: infotfs.international@tfscro.comTFS US HQ: info.usa@tfscro.com

Connect with TFS on Detailed information about TFS can be found onwww.tfscro.com

Safety First!

How you can get a professional, flexible and cost effective solution for your Drug Safety/Pharmacovigilance?

How well organized is your safety function?

Why do more and more Life Science Companies outsource their drug safety/pharmacovigilance responsibilities?Drug Safety/Pharmacovigilance can be both costly and cumbersome and yet it is integral to every aspect of the product lifecycle. Companies must manage investments, adhere to multinational regulations while adapting to ever changing requirements, and employ the expertise needed to provide effective drug safety/pharmacovigilance oversight. To build an internal department with the knowledge and experience needed is not an easy task.

TFS has the talent, expertise, and experience to provide complete safety/pharmacovigilance services, while managing the cost and minimizing risk. We can provide customized drug safety/pharmacovigilance services as part of your study, your post-marketing pharmacovigilance department, or as a stand–alone service. Our team is comprised of healthcare pro-fessionals with in-depth experience encompassing an average of 15 years in drug safety and pharmaco-vigilance.

So What To Do?The solutions that companies tend to prefer is to outsource the complete safety surveillance activity or to use external consultants who do the work within the company’s own premises.

The advantage of partnering with TFS for your drug safety/pharmacovigilance needs results in:

1. Saving Money – The outsourcing business solu-tion is a financial success both in the short and long term.

2. Increasing Flexibility – A full service safety function or a partial service safety solution to respond to your company’s fluctuations in work-load.

3. Minimizing Organizational Risk – Everyday mana-gerial challenges such as sick leave, maternity or paternity leave, high workload and constant need of internal training of personnel.

4. Using Experts - Occasionally specific and highly specialized skills are required to carry out drug safety/pharmacovigilance activities effectively.

The TFS Total SolutionTFS provides total solutions for drug safety/pharma-covigilance needs. TFS will customize a solution to fit your requirements and budget. Our safety func-tions include:

• Validated Pharmacovigilance System• Clinical and Post-marketed Safety Case Handling• Safety Signal detection• Qualified Person Responsible for Pharmacovigi-

lance (QPPV)• Medical Information • Periodic Reporting (e.g., PSUR, DSUR)• Literature Screening• Eudravigilance Registration and Reporting• RMP, RiskMAP, REMS• Medical Expert Advice and Assessment• Training• Other Services

TFS has a highly qualified global safety team of physicians, pharmacists and nurses to take care of your drug safety/pharmacovigilance needs.

Contact us and we will provide an in-depth overview of our services!

The TFS Drug Safety & Pharmacovigilance Team!

We are ready to take care of your Pharmacovigilance function!

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CONTACT US for a meeting!TFS Global HQ: infotfs.international@tfscro.comTFS US HQ: info.usa@tfscro.com

Connect with TFS on Detailed information about TFS can be found onwww.tfscro.com