With Kindeva Drug Delivery, you benefit from highly skilled regulatory support throughout the life cycle of your combination product, backed by decades of experience with global regulations and standards. Whether pre- or postmarketing strategies, our in-house experts help support all your regulatory needs worldwide with knowledge and know-how built from an array of advanced scientific, technical, and regulatory backgrounds, including an extensive understanding of FDA and EMA regulations.  

Bring regulatory expertise to your program with our partner-based, milestone-driven business model which is customizable to the specific needs of your organization to ensure success in the regulatory framework, with informed solutions for:


  • eCTD submissions 
  • Submission-ready document preparation  
  • Document storage/archives 
  • RA intelligence 
  • Management of publishing vendor  


  • New drug development (i.e., initial application) 
  • Pre-/postmarketing maintenance 
  • PMRs 
  • Labeling (new/updates) 
  • Human factors 
  • Expedited Approval Pathways 
  • Requests for Information 
  • Health Authorities (HAs) interaction 
  • Client interaction (DoD/BARDA) 


  • Labeling and artwork 
  • Change controls 
  • Advertising and promotion 
  • Internal and external HAs audits 
  • Listings 
  • CAPAs 
  • Drug shortages 
  • Annual reporting (i.e., PADERs, NDA/IND Annual Reports) 
Kindeva team members talking

Expert guidance for your regulatory pathway

Our leading CDMO is focused squarely on drug-device combination products, offering support from a regulatory team that knows the specific requirements at each stage of your product’s journey.

This in-depth understanding of how regulation for combination products and medical devices is handled also enables an exceptional degree of agility, providing the insight necessary to quickly reevaluate the application of regulations throughout the process.

Successful strategies for your combination products 

When you combine forces with Kindeva, you can count on: 

  • A proven track record of obtaining and maintaining IMPD/IND, DMF, and marketing authorization approvals from worldwide health authorities 
  • In-depth knowledge of global legislation, regulations, and guidelines for drug development to support the design and execution of optimal product development and regulatory strategies 
  • A deep bench of regulatory experts with vast technical knowledge and a commercial focus to underpin successful regulatory agency engagement 
  • A long history of outstanding partnerships and customer collaboration, leading to first-to-market product launches  
  • Successful coordination with stakeholders in developing/authoring the documentation required to support regulatory submissions  

Combine Forces With Kindeva