Drug Development and Regulatory Consultant

Services

Expert regulatory and scientific-technical advice in areas of FDA-related activities, including formulation development, commercialization and quality control of OINDP (pMDI, DPI, Nasal Spray) products.
Formulation & Process development support to OINDP products.
Facility development for OINDP products for –
Formulation development
Analytical development
Pilot Plant
Commercial production
Product development strategies and reviews
Pre FDA/MHRA etc regulatory submission activities

Clarification of FDA/MHRA etc regulatory expectations and regulations
Drug and Drug-Device Combination Products
Evaluation of CDER regulatory submissions (ANDA, DMF, etc)
Regulatory support
Product formulation related issues & troubleshooting.
Analytical Method development & validation (outsourced).
Analytical requirements at process development stage and data interpretation.
Third party data review (onsite or offsite) for documents and process adequacy and accuracy before ANDA submission.
Third party review of components and raw material supplier for quality adequacy and accuracy for ANDA submission and as per management credential.