Regulatory Submission Preparation

Our frequent interactions with regulatory authorities and our science-based approach expedites “Right First Time” submissions for a broad range of modern medicines. Kymanox® is experienced in the interpretation of applicable FDA, Health Canada, EMA, MDR, and other OUS regulations to ensure compliance. We further support efficient navigation through the multidimensional regulatory landscape from beginning to end including authoring, reviewing, and submitting documentation as well as acting as the regulatory point-of-contact for our clients as requested.
01

Submission Support

Kymanox can assist with various filing activities (e.g., IDE, IND, NDA, BLA, 510(k), De-Novo, PMA, CTA, MAA, CE Mark, NBOp, and more) from start to finish. We can conduct literature reviews, author, review and revise, and even submit documentation to regulatory bodies on your behalf.
02

Orphan Drug Designation Requests

We have helped many clients with their Orphan Drug Designation (ODD) requests. First, we conduct an assessment of the eligibility of the orphan designation, considering factors such as disease prevalence, disease severity, disease pathology, drug mechanism of action, and existing ODD indications for an Active Pharmaceutical Ingredient (API). We then prepare the ODD request per FDA requirements and submit if requested.
03

FDA Expedited Program Request

Kymanox can author or review your FDA expedited program request including Fast Track Requests (FTRs), Breakthrough Therapy Requests (BTRs), Accelerated Approval (AA) assessments or requests, Regenerative Medicine Advanced Therapy (RMAT) designation, and Priority Review (PR) assessment or requests. We will ensure these documents follow FDA guidelines and applicable standards.
04

IPSPs

Our regulatory team has experience authoring initial Pediatric Study Plans (iPSPs) and addressing FDA comments to a "non-agreement" iPSP. We can also participate in FDA meetings to negotiate requirements as applicable.

Frequently Asked Questions (FAQs)

Can Kymanox handle regulatory submissions outside the U.S.?
Yesthe Kymanox team is experienced with the regional regulatory requirements and expectations for submissions to EU, Japan, Brazil, and Canada. 
Can Kymanox author CMC (Quality) Sections of my IND, NDA, ANDA, or BLA?
Kymanox has an expert staff of regulatory and technical writers who are intimately familiar with authoring the CMC (Quality) sections for all submission types.  Kymanox is also well versed in preparing all sections of your submission, as well as Briefing Packages to support communications from Pre-IND through Pre-NDA/BLA. 
I’m developing a combination product – do I need to submit separate applications for both the drug and the device?
Some drug combination products can rely on a single application to gain regulatory approval; however, the following two main factors influence the decision on whether one or more applications are needed:
  1. The intended market – Whether the product is hitting the market in the United States of America (USA) or in the European Union (EU), each market has key differences.
  2. The type of combination product – there are regulatory differences for each type of combination product previously mentioned: single-entity/integral products, co-packaged products, or cross-labeled products