Regulatory Staff Augmentation
Availability of high-skilled Regulatory Resources made easy
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 manage your organization’s staffing needs efficiently, 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.
At Navitas Life Sciences we are experienced in driving success. Whether you are seeking a Regulatory Strategist or need Regulatory SMEs, spanning activities from Pre-Investigational New Drug (IND) to Post-Approval, we can help. With a large talent pool of some 250+ experienced 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:

- 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
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.

CASE STUDY
End-to-End IND Regulatory and Medical Writing Services
CASE STUDY
A Successful Regulatory Outsourcing Partnership
CASE STUDY
A collaborative partnership providing resources for Regulatory Affairs Technical and Publishing
Advantage of augmenting your Regulatory team with Navitas Life Sciences

Regulatory domain experts

Cost effective and efficient support

Ability to scale to meet fluctuating work volume

Flexible staffing models
Gain the Navitas Life Sciences Edge

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
