Small to large pharmas are often faced with regulatory needs that could prolong access of their drug product to the market. Handling such requirements efficiently is imperative to preventing the small gaps from becoming giant fissures, separating efficient trials from time consuming and cost heavy trials.
Navitas Life Sciences pursues such strategic regulatory needs persistently, through every phase of the clinical trial cycle, providing a wide range of resources to support unique client needs. The uncertainties that pharma companies face in plugging specific regulatory needs is now gone, as efficient management makes budgets and targets easier to achieve.
Navitas Life Sciences Regulatory Contract Staffing Expertise
Navitas Life Sciences has access to regulatory services value pools that can be leveraged to navigate the evolving regulatory landscape and ensure Patient Safety. With a rich legacy of experience and expertise, we serve as trusted advisors and provide tailored solutions grounded in industry best practices.
We can support you in the following competencies, with resources to meet your contracting needs:
- Regulatory Strategist
- Regulatory Medical Writers and Reviewers
- CMC Specialist
- Labeling Specialist
- PV Scientist
- Validation Engineer
- Technology resources in Argus, TrackWise®.
In this blog we feature an insightful conversation with Mr. Govind Srinivasan, Vice President and Business Partner, Navitas Life Sciences as he leads us through our expertise in regulatory contract staffing solution, and fine tuning vital regulatory needs of small to large pharmas with unique contract staffing services.
Tell us a bit about your professional background
I have been in the clinical trial industry for over 25 years, and with Navitas Life Sciences for over 13 years. In aligning with the changing trends in the industry, I have been able to support realistic, robust and profitable strategies for regulatory staffing solutions for multiple clients across the world.
Please give us a glimpse of your role at Navitas Life Sciences
I am the Vice President & Business Partner at Navitas Life Sciences, running delivery centers in Chennai. I have been in the U.S for 5 years now, managing clients and developing the business in the U.S Market for regulatory and safety and technology business unit.
Mr. Govind Srinivasan,
Vice President and Business Partner,
Regulatory & Safety Technology
Navitas Life Sciences
Describe your journey supporting Regulatory Contract Staffing Solutions
Navitas Life Sciences has been in the regulatory staffing service for over 12 years. We run one of the largest groups in the area globally. We have groups spread across Europe, U.S, Colombia and India. Colombia center is near shore center to the U.S Market. India addresses both Europe and U.S market. India is the largest group and addresses global submissions.
We submit regulatory filings for many clients across 100 countries. One of the key features is to ensure that submissions are right, on time and within stipulated costs. These are the guiding principles within which we offer our services.
What are the various skill sets/capacities covered under the Regulatory Services Staffing Solutions?
There is a wide variety of skill sets, Dossier/Submission Management, Regulatory publishing, medical writing, CMC writing, labeling, regulatory operations, Project coordination, strategies and people could manage FDA queries, interacting with FDA, managing regulatory requirements, labelling & Promotional materials review skills etc. are quite rare. European clients are looking for U.S regulatory experts while U.S clients are looking for European regulatory experts. Recently, we laid label-harmonizing project for multiple countries so that one label in one language could address the multiple markets so that your product cost of distribution is significantly reduced.
The spread of skills sets right from operations to strategy, regulatory submissions, product life cycle management, NDA, BLA, IND and various labelling requirements are covered by us.
What are the challenges faced by clients which are effectively overcome by our Regulatory Contract Staffing Services?
In regulatory services, there is a need for
- Periodic reporting and product life cycle requirement and there are ad-hoc requirements based on filing for specific product approvals
- Regulatory strategist, to provide guidance from IND stage through NDA and post-approval support for critical therapeutic area has increased
- Regulatory strategist to support on local/In-country regulatory requirements etc.
- Labeling & Promotional specialist to review labeling & promotional document, handle the Health Authority queries and ensure compliance
Managing these requirements are very challenging. There are times when there is an increased need for regulatory services, and it must be completed with the right skill sets. That’s where Navitas Life Sciences plays an important role. We help to smoothen your resourcing needs. We bring in the right experts based on multiple geographies and health authorities.
Region and health authority specific Experts
Getting the right skill sets for the different health authorities and In-country strategists is another a big challenge for customers in this marketplace. Navitas with its spread in North America, South America, Europe, APAC and Australia gives you significant spread, which companies have to invest considerably in to get such skill sets. At Navitas, you get expertise at reasonable cost.
Global Team and Offshoring Capability
We have a global delivery team, with a local country specialist in terms of In-country strategist and regulatory affairs specialist in submission management & publishing, submission authoring (CMC) and in labeling.
The mundane heavy lifting work in calculating the submission files will be offshored, providing cost advantage without compromising on quality and time deliverables.
An error will push up approval cost and affect timelines. Navitas Life Sciences, with its significant resource spread across the globe, effective quality and governance framework and SMEs can provide first time right submissions.
How will Regulatory Freelance Candidates enrich existing teams?
Companies that do not have the required expertise, services that they don’t have within their internal team, they outsource like for label management or regulatory submission and publishing.
When seeking out an independent freelance candidate for such tasks, it could put the pharma company at very high risk. You don’t know the person, and you don’t have the support of an organization to ensure that candidate has the right skill sets.
This is where Navitas Life Sciences comes in handy as it gets the consultants quickly, ensuring that they meet your requirements and offering their services at costs that are easily affordable. In terms of cost, ease of access and availability of the right skill sets, we offer an advantage over finding independent freelance candidates. Our regulatory consulting services will enrich your team with the right candidate for the task, aiding in smooth market reach of your drug products.
Is there an option for permanent employment through Regulatory Professionals Consulting Services?
Certainly, in some companies where some clients have hired our resources, we have supported transition into their team to become a permanent member. This, however, does not happen at a very high frequency. Typically, after a year or two, some clients absorb freelance candidates who have been working with them for a long time.
How do you ensure a great experience for the regulatory consultants and the clients?
Our biggest strength is the breadth of the skills sets that we offer and our comprehensive support in ensuring that you get the right individual. For example, one of our clients in the Princeton area, in the U.S, was looking for a regulatory strategist and an operations specialist. However, they soon found out that they needed someone for labeling review, but these two individuals did not have the relevant expertise. It would not have been prudent to hire a full-time person for that as the role required only 10 hours per week for review. Navitas stepped in by finding the right candidate from its group of specialists, within the U.S, to support their needs.
Similarly, there were requirements for End-to-End dossier management, for writing documents for module 1 to 3, publishing, labeling and more. We were able to quickly provide for those skill sets. The breadth of skill sets, availability for full time/ part time, and the quality control in case they are not good, to quickly find a replacement, without affecting the project are unique solutions for transformative support.
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
We manage the dominant strain of preparing and managing contracts with the individuals, letting clients bask in the overall efficiency of the services provided. The contract could be employment; it could be hourly, independent freelance contractor, or more. We can have a boutique of relationship with the consultants. At the same time, managing the right expectations, availability, quality and the spread of skillsets makes it great for the customers to work with us.
Navitas Life Sciences was Featured in the COVER of Industry Tech Outlook magazine
Global Head of Regulatory and Safety,
Navitas Life Sciences
“Providing a Single Source of Truth”
Published in October 2021
“We hold 8 Life Sciences focused technologies that have been developed to meet the unique needs of the industry and provide a single source of truth. The unique technologies developed for Regulatory Affairs and Pharmacovigilance enable organizations to be compliant with the latest regulatory requirements”
Navitas Life Sciences was recognized as a ‘Top 10 Pharma and Life Sciences Tech Solution Provider 2021’