Pharma IP Strategy provides the following consulting services.
Pharma Consulting
- Provide strategy for the pharmaceutcial development of ANDA and NDA products
- Pipeline selection for API and finished dosage form
- Sourcing hard-to-find API and identifying contractor for hard-to-develop dosage form
- Assist your current contractor to streamline your product development efforts
- GMP evaluation of your development and manufacturing practice and facility
- Market assessment of pipeline product for US, EU and other countries
FDA Consulting
- Development strategy for the 505(b)(2)NDA and ANDA submission
- FDA and ICH guidance interpretation
- Assist regulatory filing for IND, ANDA and NDA
- Assist your meeting with FDA (Pre-IND, end of Phase II, and Pre-NDA)
IP Consulting
- Develop patent strategy for chemical, process, formulation, and pharmacokinetic
- Evaluate Paragraph IV strategy for your product
- Provide training for your scientist in intellectual property strategy
- Due diligent evaluation of product or company