Companies
With submission strategies for IND, NDA, ANDA, and post-approval submissions, as well as pre-IND, ANDA planning meetings, Technical Assessment, CMC Consulting Matters, Advice on Pharmaceutical Stability Testing, & More
Companies
With submission strategies for IND, NDA, ANDA, and post-approval submissions, as well as pre-IND, ANDA planning meetings, Technical Assessment, CMC Consulting Matters, Advice on Pharmaceutical Stability Testing, & More
Services Offered
Regulatory and technical advice related to NDA (505 (b) (1) and (b) (2)), ANDAs, DMFs, INDs, Deficiency response evaluation to the Agency, device qualification and performance, and other FDA briefing documents for many therapeutic classes of drugs and various dosage forms
Pharma Modus LLC will be able to provide strategic consultations for CMC-technical matters. In addition, we offer product development report evaluation, pre-submission technical assessment, and FDA Guidance interpretations from a practical perspective
Technical Consulting and other online services.
Whether you are a start-up or an established firm looking for a competent regulatory strategist, Chemistry, Manufacturing, and Controls area, and devices advice for submission evaluation to the FDA – connect with us
Why Choose this Company
The consultant, Radhika Rajagopalan, has vast expertise in pharmaceutical product development, stability assessment, and brings in years of experience to offer you the best services.