Regulatory Affairs
Karya's marketplace platform is built for independent consultants to aid life science companies in navigating the regulatory landscape.
Our goal is to simplify the complex processes of pharma, biotech, and medical device regulations, ensuring your project's success. With experts in U.S. and European regulations, our consultants offer strategic guidance and detailed plans for product development, submission, and post-approval operations, including launches and regulatory maintenance. Our global network of experts, including pharmacologists and chemists, has a strong track record of steering products through regulatory challenges, making Karya the platform for life science companies aiming for regulatory success.
Submissions and Applications
Karya's marketplace connects companies with a network of independent consultants specializing in regulatory submissions and applications.
With a focus on the life sciences sector, these consultants offer expert guidance throughout the entire development and launch processes, ensuring clear and complete submissions for both US and European markets. Whether it's navigating the complex terrain of FDA submissions or EU regulatory requirements, Karya's consultants provide tailored solutions for key regulatory submissions, including INDs, NDAs, ANDAs, ODDs, BLAs, IDEs, 510(K)s, PMAs, and more.
Expert IND Submission Support
For companies seeking Investigational New Drug (IND) clearance from the FDA, Karya's consultants offer guidance at every step of the process.
From developing a robust Pre-IND Meeting strategy to ensuring error-free submissions with all required information, our consultants help streamline the path to IND approval, enabling companies to initiate clinical trials efficiently.
NDA Submission Expertise
Navigating the rigorous process of New Drug Application (NDA) submission requires careful planning and execution.
Karya's consultants provide insight into choosing the right regulatory pathway, whether it's the traditional 505(b)(1) or the 505(b)(2) pathway, ensuring that submissions meet FDA requirements and increase the likelihood of approval.
ANDA Consulting Services
Developing a generic drug product and obtaining approval through an Abbreviated New Drug Application (ANDA) process can be challenging.
Karya's consultants assist companies in demonstrating bioequivalence to the Reference Listed Drug (RLD), developing submission strategies, and compiling comprehensive ANDA submissions for FDA review.
Orphan Drug Designation Support
Securing orphan drug designation requires a deep understanding of disease prevalence and regulatory processes.
Karya's consultants work with companies to determine eligibility, develop complete applications, and navigate the complexities of orphan drug submissions, ensuring that valuable therapies receive the recognition and support they deserve.
Biologics License Application (BLA) Assistance
Submitting a Biologics License Application (BLA) for vaccines, allergenic drug products, or cellular and genetic therapies demands meticulous planning and execution.
Karya's consultants offer extensive experience in planning and navigating the BLA process, helping companies achieve successful submissions and expedite market entry.
Regulatory Authority Meetings and Pre-NDA Consultation
Preparing for regulatory authority meetings and Pre-NDA consultations requires careful planning and expert guidance.
Karya's consultants assist companies in strategizing and executing successful interactions with regulatory agencies, ensuring clarity and efficiency throughout the process.
Regulatory CMC Consulting
Defining manufacturing practices and product specifications is crucial for ensuring product quality and consistency.
Karya's consultants guide Chemistry, Manufacturing, and Controls (CMC), helping companies develop robust CMC strategies and navigate regulatory requirements at every stage of the product lifecycle.
Advertising & Promotional Review Services
Developing compelling and compliant messaging is essential for successful brand growth.
Karya's consultants offer comprehensive Advertising & Promotional Review services, helping companies navigate regulatory requirements and launch effective marketing campaigns.
Market Access & Reimbursement Strategy
Crafting bespoke Market Access and Reimbursement strategies is critical for connecting innovative medical solutions with those in need.
Karya's consultants specialize in developing comprehensive strategies that maximize patient access, investor confidence, and commercial success across therapeutic products, medical devices, and diagnostics.