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:

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  • 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.

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CASE STUDY

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End-to-End IND Regulatory and Medical Writing Services

Learn how supported a mid-sized biopharmaceutical company headquartered in the USA to secure US FDA approval for a Phase I study to proceed

CASE STUDY

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A Successful Regulatory Outsourcing Partnership

Learn how we are supporting a top 5 global pharma company with Submission Management, Publishing, and Produce License Support

CASE STUDY

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A collaborative partnership providing resources for Regulatory Affairs Technical and Publishing

Learn how we have successfully provided a team of dedicated resources serving as an extension to our client’s RA team, to support their technical and publishing operations

Advantage of augmenting your Regulatory team with Navitas Life Sciences

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

Flexible staffing models

Flexible staffing models

Gain the Navitas Life Sciences Edge

Qualified Freelance contractors

Qualified Freelance contractors

Reasonable pricing

Reasonable pricing

Quick replacement of freelance experts

Quick replacement of freelance experts

Quality Assurance

Quality Assurance

Management of contracts with Freelancers

Management of contracts with Freelancers

Right-First-Time Submissions

Right-First-Time Submissions

Quick turn-around time

Quick turn-around time

Process refinement, Effective governance and Continuous Improvement

Process refinement, Effective governance and Continuous Improvement

Minimize Health Authority Queries

Minimize Health Authority Queries

Minimize Operation Costs

Minimize Operation Costs

BLOGS

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Medical Writing Services CRO: The Navitas Life Sciences Advantage

Navitas Life Sciences stands at the forefront, offering comprehensive Medical Writing Services tailored to diverse therapeutic areas, ensuring clients meet their clinical and regulatory needs with finesse and efficiency.
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3 Recent Key Regulatory Services Success Stories

The ever evolving regulatory environment places heightened emphasis on Patient Safety. We serve as a trusted advisor with a rich legacy of experience and expertise, providing unique and personalised solutions grounded in industry best practices.
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How Navitas Life Sciences Addresses your Regulatory Needs with Expert Regulatory Contract Staffing Services

We have access to regulatory services value pools that can be leveraged to navigate the evolving regulatory landscape and ensure Patient Safety.

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