Streamline your Regulatory Affairs
We work with our clients on a one-on-one basis, offering close and dedicated attention to create tailored regulatory operations solutions that save time and reduce costs. Some examples of our personalised solutions are:
Gap Analysis for Recent ANDA Acquisitions
We deliver in-depth gap analysis reports that identify unresolved issues and outline a clear roadmap to commercialization. Each report includes a complete review of the recently acquired ANDA along with all related FDA communications, from deficiency notices to Complete Response Letters (CRLs).
Risk Mitigation for CMO Migration
We manage transitions between Contract Manufacturing Organizations (CMOs) by reviewing supplier qualification and compliance. Our goal is to match our clients with the best production partners based on capacity, quality standards, and cost-efficiency.
Strategic API Sourcing
We help clients to build robust supply chains through comprehensive API procurement. We secure reliable partners, negotiate favorable terms, and safeguard consistent product availability to meet distribution targets.
Primary Packaging Configuration
From finding the right packaging to testing product label designs, we offer sourcing and operational assistance that fulfills the current regulatory, technical, and market requirements for primary packaging.
Streamline your Regulatory Affairs
We work with our clients on a one-on-one basis, offering close and dedicated attention to create tailored regulatory operations solutions that save time and reduce costs. Some examples of our personalised solutions are:
Gap Analysis for
ANDA Acquisition
Risk Mitigation for CMO Migration
Strategic API Sourcing
Primary Packaging Configuration
Optimize your regulatory operations with J. Molner
J.Molner helps clients to navigate the complex landscape of regulatory operations to improve compliance and accelerate time-to-market by offering:
Personalised Service
Regulatory Expertise
Submission Management
International Regulatory Knowledge
