Navitas Life Sciences delivers outcomes for Regulatory Affairs through a model that reflects your organization and ensures that you have a complete oversight of your product life cycle with quality and compliance.
With over 20 years experience, we have successfully delivered 170,000+ Regulatory Submissions across the globe for Pharma & Medical Devices companies. Our 160+ regulatory professionals work with you to ensure First-Time-Right submissions.
We have a successful proven track record of Regulatory Submission Management services for North America, EU and APAC regions for both initial and Product Lifecycle Management Submissions.
Quality by Design
CMC Technical Authoring
Direct Interaction with Health Authorities
Submissions Authoring is key step in achieving Chemistry, Manufacturing and Controls (CMC) compliance to ensure that drugs produced are safe and effective for human use.
The main challenge in Submissions Authoring is that it requires close coordination between non-clinical, clinical, regulatory, safety, quality, marketing and other stakeholders to implement any change requests.
Navitas Life Sciences offers submission management services to enable compliance by providing regulatory guidance during the drug development process to help you submit in a timely fashion. Our team has expertise in CMC technical authoring, reviewing your drug substance and drug product related documents to ensure 100% compliance and minimize the number of post-filing queries from regulators.
We have resources readily available for CMC activities for both initial and Product Lifecycle Management submissions covering 20+ Therapeutic areas for North America, EU and APAC regions.
Regulatory Submissions need to comply with evolving HA requirements for compiling pre and post-approval submissions aligning with submission strategy. Product Lifecycle Management (PLM) is key for managing the entire lifecycle submissions and product maintenance in the market.
Some challenges your team may encounter while managing regulatory submissions activities include:
Managing vast amount of data
Coordinating with internal and external stakeholders
Navitas Life Sciences can support your Regulatory Submissions through Creative Engagement Models from submission planning throughout the product lifecycle. We are highly experienced in coordinating with various stakeholders, preparing the final submissions in compliance with HA requirements across the globe for various applications including IND, NDA, ANDA, MAA, BLA, CTA and DMF. Some activities include:
Queries to Submissions
Change Requests (Variations & Supplements)
Periodic Safety Update Reports
Re-registration of Dossiers
We have resources readily available for Submissions Compilation activities for both initial and Product Lifecycle Management submissions covering 20+ Therapeutic areas for North America, EU and APAC regions.
Regulatory submissions need to publish in International Conference on Harmonisation (ICH) format for all pre and post-approval submissions.
Some organization face challenges with limited oversight on end-to-end publishing process and systems.
Navitas Life Sciences enables your Regulatory submissions to publish in compliance with Health Authorities across the globe for both simple and complex applications (including IND, NDA, ANDA, MAA, BLA, CTA and DMF) throughout the product lifecycle.
We have resources readily available and technology for publishing eCTD, NeES and paper formats for all types of submissions for North America, EU and APAC regions.
Archival systems are necessary for your organizations long-term preservation (LTP) policy. In addition, archival repository can be utilized for future reference, handling risk management, data migration and audit support.
Telematic Implementation Group on electronic Submission (TIGes) in 2011 gathered a specialized subgroup with the mandate of producing Best Archiving Practice guidance.
We provide a very systematic archival process for all types of submissions covering Initial Submissions and product lifecycle management submissions including client specific systems.