Our Services
Test Licence for Pharmaceuticals on Form 29.
Import Licence for API.
Import Licence for Innovator product.
Formulation development for US/EU/ROW market.
Development and Technology transfer.
Pilot BE study.
Connection with CRO & CMO’s for development and execution of all kind of dosage forms like Tablets, Softgel, Hard gel Capsules, Topicals, Injectables, Oral films, Oncology and Liquids Exhibit batches and Filing support for US / EU /Canada / Australia / ROW market.
Strong connection with CRO center for conducting BE and clinical studies for US/EU market.
Identification of CRO which is already expertise in similar product to circumvent the BE failures.
Quality/cGMP Audits: Pre-Agency Assessment Audits, Mock Audits, Vendor Qualification Audits.
CMC Dossier Writing: ANDA, NDA, BLA, DMF, VMF, IND and 505(b)(2) and MAA filing for Global markets.
Labeling: Preparation Package Insert / SmPC & Artwork.
US Regulatory Agent: Controlled Correspondence and USFDA Communication.
Other Regulatory Services: PDE, and OEL
Identification of generic product for US/EU/Canada/Australia/ROW Market.
Identification of first to file product.
Identification of para IV product.
Identification of complex generic.
Identification of niche opportunities.
Identification of product as per therapeutic category.
Identification of product as per dosage form.
Identification of 505b2 opportunities for US Market.
Identification of innovative product for world wide market.
505b2/Innovative product recommendation.
IP Due diligence of Dossier
Freedom to operate opinion
Non infringement Opinion
Designing IP strategy for non-infringing product
IP Due diligence of invention /patent for out licensing
Patentability Opinion on invention
Patent filing and Drafting
Patent prosecution – Filing request of examination/ Replying to office actions/hearing/annuity payments.
Patent Invalidity searches
Key literature search
Patent landscape report
Other scientific trouble shooting
Out licensing of product
In licensing of product
Development projects
Co-development project
CMO opportunities
IMS Data
