Regulatory Staff AUGMENTATION

Availability of high skilled resources made easy

OUR TEAM OF EXPERIENCED PROFESSIONALS CAN SUPPORT YOUR REGULATORY STAFF AUGMENTATION NEEDS

Are you increasingly faced with regulatory needs that could prolong access of your drug product to the market? Our highly qualified team of Regulatory experts are available to efficiently manage your organization’s staffing needs, making budgets and targets easier to achieve. With global availability and adaptable staffing models we provide both flexibility as well as confidence to meet your end-to-end Regulatory Service needs.

Providing End-to-End IND Regulatory and Medical Writing Services

Read our Case Study and learn how we supported a mid-sized biopharmaceutical company headquartered in the USA as we augmented their team to provide end-to-end IND Regulatory and Medical Writing services to secure the necessary approval for a Phase I study to proceed

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ARE YOU LOOKING FOR EXPERIENCED REGULATORY SUBJECT MATTER EXPERTS (SMEs) TO AUGMENT YOUR EXISTING TEAM?

At Navitas Life Sciences we are experienced in driving success. If you are seeking a Regulatory Strategist or need Regulatory SMEs, spanning activities from Pre-Investigational New Drug (IND) to Post-Approval, then look no further. With a large talent pool of some 250+ Regulatory professionals, we can support your organization and operate as an extension to your team. With experts available across geographies, your global staff requirements can be easily met.
Our team boasts a niche skillset, not always easily available, which includes:
Regulatory Strategists
  • Well versed in Regulatory Strategy with practical involvement
  • Comprehensive Regulatory approval expertise
  • Experienced in handling Health Authority (HA) negotiations
  • Knowledgeable across multiple Therapeutic areas including Oncology
  • Ability to develop and manage contingency strategies from Pre-IND through all clinical trial phases for drugs, biologics, and medical devices
  • Appraisal and investment due diligence for venture investors
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Harness our talent to help you stay on target and deliver on your regulatory milestones

We appreciate that staffing requirements and demand can be cyclical or dependent on project work. We make sure that all compliance and administrative requirements are fully met. Our staffing model offers convenience, flexibility, and the ability to quickly access resources when required. We are able to support a 24/7 staffing model where required to keep your Regulatory operations moving forward.
We successfully manage staff attrition for our clients to prevent delays and issues occurring. We always ensure that we have a fully-trained pool of resources available to handle volume spikes.

ADVANTAGE OF AUGMENTING YOUR REGULATORY TEAM WITH NAVITAS LIFE SCIENCES

Flexible staffing models

Flexible staffing models

Regulatory domain experts

Regulatory domain experts

Cost effective and efficient support

Cost effective and efficient support

Ability to scale to meet fluctuating work volume

Ability to scale to meet fluctuating work volume

BENEFITS OF CHOOSING NAVITAS LIFE SCIENCES’ REGULATORY CONTRACT STAFFING SERVICES

  • Qualified Freelance contractors
  • Reasonable pricing
  • Quick replacement of freelance experts
  • Quality Assurance
  • Management of contracts with Freelancers
  • Right-First-Time Submissions
  • Quick turn-around time
  • Process refinement, Effective governance and Continuous Improvement
  • Minimize Health Authority Queries
  • Minimize Operation Costs