top of page

DRUG PRODUCT

Need help getting through your brand or generic drug development and regulatory submissions?  Not sure what analytical data, studies, or methods are required?   Are you experiencing problematic commercially-marketed products with specification and/or stability failures?

 

BRAND OR GENERIC DRUG PRODUCTS:

 

  • Immediate and extended release solid dosage forms (tablets, capsules)

  • Liquid Oral dosage forms (solutions and suspensions)

  • High- versus low-barrier to entry generic drug development

  • Analytical data required to support development and submission 

  • Dissolution profile studies

  • Excipient compatability studies

  • Compendial method requirements and comparability

  • Comparability to the Reference Listed Drug (RLD)?

  • Specifications and test criteria

  • Stability study requirements

  • Second-source API qualifications and approval

  • Post-Approval changes to specifications, test methods, packaging

  • API procurement and qualification

 

 

PROBLEMATIC DRUG PRODUCT INVESTIGATIONS:

 

  • Solid and liquid oral dosage products, sterile injectables

  • Sudden commercial batch failures

  • Changing impurity profiles

  • API supply issues and constraints

  • Manufacturing process-related challenges

 

bottom of page