Amedio CMC Consulting

Amedio CMC Consulting LLC

Drug Substance

• Environmentally friendly synthetic route design

• Process development and optimization

• Process validation

• Control of physical properties (particle size, crystal forms and

polymorphs)

• Physiochemical characterization

• Identification and development of salt forms

• Impurity and genotoxic impurity classification

Drug Product

• Formulation development

– terminal sterilization of injectable solutions

– aseptic processing of lyophilized products

– solid dosage forms (capsules, tablets, ODT, ophthalmic form)

• Bioavailability enhancement of poorly soluble compounds (spray

dried dispersion and hot melt extrusion)

• Support formulation changes during all stages of development

• Packaging design and implementation

Quality Assurance

• Batch record and documentation review and audit

• Maintain internal controls over quality policies, procedures, and

specifications

• Author and review SOPs

• Provide ongoing support and review of Quality Systems

CMC Regulatory Affairs

• Author and review CMC regulatory submissions for pre-IND

meetings, INDs, Annual Reports, Amendments, Type C briefing

books , IMPDs and NDAs

• Participate in face-to-face FDA meetings (pre-IND,

end-of-phase 1, end-of-phase 2 and pre-NDA)

• Review CMO DMFs.

• Provide scientific & regulatory strategy for CMC planning from

proof of concept through commercialization

• Clarification and application of FDA and ICH guidances relevant

to CMC development activities

Manufacturing and Analytical R&D

• cGMP manufacturing scale-up and troubleshooting

• Implement Quality by Design (QbD)

• International and domestic CMO sourcing and management

• Cost management for manufacturing process

• Material sourcing

• Manage technology transfer to and from CMO’s

• Clinical and commercial supply planning and delivery

• Analytical methods development, qualification and validation

• Develop release test methods and specifications

• Design and monitor stability programs

Amedio Consulting provides hands-on expertise that cover CMC services throughout the entire drug development process.

Providing Excellence in Chemistry, Manufacturing and Controls (CMC) Consultation