Overview

In an ever changing Regulatory landscape, the biggest challenge for the Pharma/Lifesciences companies is to achieve the right staffing balance to meet the time-critical health authority mandates. The timely allocation of right resources would be a critical factor. Either obtaining the right resource at the last-minute or managing them in-house, companies would find it difficult to cope with the risks and costs involved. In such scenarios, choosing a right partner for staff augmentation would help companies to successfully meet the staffing requirements at the right time and at reduced costs.

Freyr’s Staff Augmentation services help clients perform all the Regulatory tasks without fail in order to fulfill the mandate requirements on-time. Freyr provides low-cost Onsite Regulatory Contract Staffing Services for the USA, Europe, the EU and the UK which can serve your deployment requirement that range from two weeks to multi-year engagements. Either a short-term resource gap or a long-term requirement, Freyr’s specialized contract staffing services provides dedicated teams of Regulatory personnel to manage the time-critical projects efficiently. Freyr offers Staff Expansion services in a scalable, affordable and convenient way.

 

Freyr Capabilities

Maximize your cost savings to 20-50% or more depending on the requirement, as compared to the traditional consultants. Freyr has the capability to cater Contract Staffing services for the following Regulatory functionalities.

Publishing

  • Publishing Specialist
  • Senior Publisher
  • ISI toolbox specialist

Labeling

  • Regulatory Labeling Specialist
  • Global Labeling Consultant
  • Regulatory Labeling Associate
  • Senior Labeling Specialist
  • Labeling Manager
  • Global Labeling Lead (senior profile)
  • Specialist in Core Data Sheet (CDS) authoring services

Regulatory Affairs 

CMC
  • CMC Specialist
  • CMC Manager
  • CMC Information Management

Dossier Preparation specialist

Medical Writing and Clinical Services
  • Medical Writer
  • Senior Medical Writer
  • Medical Reviewer
  • Clinical Trial Monitoring Specialist
Audit and Compliance
  • Training Services
  • Validation Services

Regulatory Information management

  • XEVMPD specialist
  • IDMP solution specialist
 

Freyr Advantages

  • Readily available resources for immediate deployment or with advance notice of 3-8 weeks depending on the requirement
  • Onsite staffing for short, mid and long-term positions with cost advantage of 20-40% and with alternative staffing methods with cost advantage of up to 70%
  • Global staffing expertise– USA, Europe, EU, NA, Middle East, Africa, Asia Pacific
  • Highly scalable resource model 

CLIENT TESTIMONIALS

 
  • I approached Freyr with an issue we were having in quickly confirming the global acceptability of several new raw materials for use in our products. Within a few days, their team provided me with a comprehensive review by country citing regulatory references. The reports also included valuable additional information regarding cosmetic uses of the materials in various markets. For a very reasonable price, Freyr was able to provide our company with exactly what we were looking for.

    – Director, Regulatory Affairs, US based, Cosmetics Manufacturing Company

  • Freyr provided assistance and the review was conducted thoroughly and rapidly. I also appreciate that the team called me this morning and walk me through the files. It is once again a pleasure working with Freyr.

    Just wanted to say that the team are doing a great job. Please keep up the excellent work!

    – Product Specialist Global Regulatory Affairs, Global Top 5 Healthcare Company