HeliPharm Consulting Services

Driven by outcomes we are devoted to helping pharmaceutical companies achieve project and business goals. We can serve as an extension to your drug development team or work independently providing high-quality results while reducing risks.

We take great pride in our ability to build enduring partnerships with our clients in all phases of drug development.

CMC Technical Excellence

We have extensive hands-on experience in all stages of small molecules drug product development, and we can help with the following drug development challenges:

CMC strategy development
Tech transfer
Pre-formulation, formulation development, and process optimization of solid oral products
Drug product manufacturing: CTM, registration, drug product process validation campaigns etc.
Risk assessments
Relevant drug product documentation review
Due diligence
Fractional leadership

CDMO Management

We have a deep understanding and broad connection to the global CDMO network for solid oral therapeutics which allows us to help you identify and engage the best partner for your project. Our services include:

Request for proposal (RFP)
Vendor assessments and selection
Vendor technical audits
Project and program management
Overseeing and monitoring day-to-day activities

Regulatory Support

We have a solid knowledge authoring CMC Module 3, and we have contributed to four NDA, over ten IND/IMPD including 4 breakthrough therapy designation drug development programs received from the FDA. We can support you with the following while focusing on your business goals:

Author CMC Module 3 section(s) in regulatory documents
Technical review of regulatory documents
Perform gap analysis for CMC source documentation
QC the data going into regulatory submission
Draft technical questions prior to regulatory meetings
Address/respond to regulatory CMC questions on submissions