⚫ Scientific, legal and commercial analysis of a products.
⚫ Technological feasibility, competition analysis, cost of development and Return on Investment projections.
⚫ Incremental innovations to work around maze of patents and make the product niche .
⚫ New Dosage Form, New Combination and New Drug .
⚫ Product differentiation and life cycle management of high value products.
Regulatory Strategy is the way to streamlining the improvement assets for worldwide advancement of API and completed products.
⚫ Assess the global regulatory landscape based on each local regulatory and market needs (R&D considering all regulatory agencies like USFDA. EMA, MHRA and ROW).
⚫ 505(b)2 and Pre NDA preparations.
⚫ Evaluation and Recommendations of API and Drug product for IP landscape across the globe.
⚫ Product, process, method of use patent for US,Canada,EU and ANZ markets.
⚫ Formulation patents.
⚫ Patent Attorney opinion
⚫Litigation advise and identifying right legal attorney for different markets.
⚫Settlement with respect to different CMO and companies.
⚫ Identification and evaluation of CRO.
⚫ Accurate designing of animal/BE study protocol.
⚫ Animal toxicity study for DCGI Submission.
⚫ Impurity qualification with animal Study.
⚫ Genotoxicity evaluation with animals.
⚫ Dog PK Study.
⚫ Forward integration of API companies
⚫ Backward Integration of Finished Dosage Forms (FP) companies for NDDS, Depot, Simple Injection and Solid oral formulations.
⚫ Infrastructure Development (Man, Machine, Plant)
⚫ QbD Implementation for Formulation Development of NCE/ANDA/NDDS
⚫ Galenical/Lab scale Oral, Topical and Injectable Formulation Development
⚫ Bio-availability Enhancement of API through Formulation
⚫ Formulation upgradation
⚫ Technology Transfer
⚫ New Dosage Form & New Combinations
⚫ Import /export of different Products.
Email: info@emcyto.com
Phone: +91 85111 77053
H/2 Sayona Park,Memnagar,
Ahemdabad,Gujart-380051,India
Biopharma Incubation center at NIPER - ahmedabad