Our Services

We provide a wide range of professional services to meet your needs. We are committed to providing a personalized CMC end to end service for you.

IND/IMPD/DMF/NDA/MAA expertise for drug substance and drug product eCTD authoring.
Design and implement regulatory strategies for pharmaceutical and combination products for early stage through commercialization.
Regulatory agency meeting CMC oversight (Pre-IND, EOP2, Pre-NDA, Type C).
Change control management for all stages.
Technical CMC report authoring.
Advice on developmental, manufacturing, analytical, and supply chain challenges in relation to RA CMC.
Integrate with nonclinical and clinical development programs to ensure product availability.
sNDA strategy, authoring, and filing.

Identify and select project-appropriate laboratories/sites to conduct development.
Route evaluation, scale-up, and phase appropriate oversight at process and analytical sites
Regulatory starting material definition and designation.
Contract site management for development of synthesis and formulation.
Quality by Design (QbD) approach where appropriate.
Stability protocol design and implementation for API and DP.
Couple technical development with regulatory requirements for efficiency.

Full oversight and ownership of process and analytical transfer to contract manufacturing sites.
Due diligence and guidance on CMO selection for API and DP.
Technical review of GMP documentation for manufacturing.
Project timeline oversight and defining key milestones with potential road blocks for technical site transfers.
Validation protocol drafting and oversight of validation studies at manufacturing sites.
Specializations in API manufacturing, tablet formulations, and various aseptic manufactured drug products.
Couple technical transfer activities with regulatory requirements.

Commercial launch readiness for new product introductions.
Integrate with technical transfer, validation, and regulatory functions to ensure supply chain readiness and reliability.
Generate and manage capital portfolio for commercial equipment and site including COGS/CIP.
Facilitate CLS and distribution team strategy and implementation.

CMC team management and oversight to drive cross-functional team members to overall program success.
Microsoft project and other dedicated software expertise in end to end program CMC management.
Develop and implement strategic road maps for complex products and supply chains.
Advise key stake holders on program status and challenges while translating impacts, risks, and resolutions clearly.

Drug/Device expertise in development and commercialization of combination products.
cGMP guidance in implementation of regulations for device and drug manufacturers.
Request for designation guidance.
Regulatory authoring and filing expertise for combination products including 505(b)2 routes.
Facility design and build for dedicated combination products.
Expertise in highly unique combo products that are new to the FDA.