Meadowlark BioPharma, Inc.

Strategic Planning, Expert Preparation and On-Time Execution of global regulatory submissions ensuring a high probability of success. We guide project teams all the way from initial project planning, authoring of documents, data review, finalization and submission to the health authority.

Multi-modality expert input on global regulatory CMC strategies including, phase-appropriate, content guidance for INDs/IMPDs, risk-based CMC strategies for successful global marketing applications, post-approval CMC changes and efficient health authority interactions.

 Authoring of CMC sections of regulatory submissions including initial IND/IMPD, global marketing applications, post-approval variations, renewals, health authority meeting requests and briefing documents, Post-approval change management protocols (PACMPs), Product life-cycle management (PLCM) documents, risk-assessments, and other regulatory documents.

Dependable, accurate and high-quality output to achieve successful global regulatory submissions and health authority interactions. We believe in on-time and right-first-time approach to our regulatory submissions.

Perform global regulatory impact assessments, support for CMC compliance and issue management related activities, and pre-approval / pre-licensure inspection support and inspection readiness assessment at manufacturing sites. 

Comprehensive regulatory CMC solutions tailored to your specific needs covering multiple product types and modalities.