Technical
Services

    • Full service management of new MA applications (CTD/ANDA/ACTD /DMF)

    • Delivery of non-clinical and clinical overview and summary

    • Running procedures like MRP/DCP

    • Management of API master file

    • Management of regulatory maintenance (incl. variations and renewals)

    • Technical services on SPC, R&D projects, and site transfer projects

    • Maintenance and preparation of license particulars

    • Setup and implementation of PV processes & systems

    • Literature search

    • Case processing

    • Safety data exchange

    • Drug interactions

    • Safety database management

    • PSUR writing and submissions

    • Signal detection

    • Review, assessment and update of SOPs; integration with QMS

    • Audits: preparation and query responses

    • Eudravigilance activities

    • Safety database implementation and project management

    • XEVMPD maintenance

    • QPPV nomination

    • Identification and management of site transfer projects

    • Comprehensive delivery from sourcings, protocols, artwork, regulatory, validations, leading to smooth supply chain

    • Strategy for variations and variations filings

    • Comprehensive support for quality designate

    • End-to-end setup of comprehensive quality systems

    • Quality engagement with manufacturers: Technical agreements, formulation/API site audits, APQRs, complaints investigations

    • Management of batch release: Review of batch records, process validation protocol, deviations follow ups

    • Management of country-specific site release procedures as support to quality designate

    • Assessments of IP landscape for formulations and API

    • Patents, data exclusivity, SPC, PED

    • For in-market and future products

    • Development of new product strategies

    • Launch planning

    • Coordination of consultant/attorney reviews in India or in local countries

Business
Development

  • In-licensing / Out-licensing

    • Wide network of companies offering products

    • Through MA transfer, ongoing DCP/MRP, CTD/ANDA

    • Access to R&D pipeline products

    • Access to sales & marketing companies in EU, US, India

    • With or without supply

    Formulation & API R&D

    • Network of R&D partners with diverse technology infrastructure

    • Set up and management of multiple projects with multiple strategic partners

    • Flexible commercial models for optimum investment plan

    • BE studies: Strategy, set up & coordination at approved centers

    • Analytical services: Method development, validations

    • Leaching and extraction studies

    • Stability studies for multiple zones

    • Advise on RLD selection, sourcing

    • Partners with EU & USFDA approved sites for formulations, API & intermediates

    • Management of entire chain from PO to delivery with multiple partners

    • Commercial negotiations and techno-commercial agreements

    • Sourcings: Cost effective API, special excipients, packing materials, capsules

    • Innovative strategies for multiple markets

    • Fast launch planning

    • Management of EU batch testing & release

    • Artworks publishing & management

    • Procurement of equipment for manufacturing and R&D

    • Establishing marketing tie ups with partners who have local presence

    • Network of companies looking to acquire/divest assets/companies

    • Coverage of India, EU, US and RoW

    • Identification of lead companies, negotiating initial terms, agreements

    • Assistance in assessments and transition

    • Arrangement for funding of projects by PE, VC, individuals

Marketing &
Sales

    • In depth market analysis

    • Regulatory requirements for market access

    • Development of market entry strategy

    • Generating of substantial marketing & business plans

    • Distributor search & controlling

    • Agency-/ Licensing agreements

    • Regional market focus: Germany, Austria, Switzerland, India, GCC

    • Regulatory due diligence

    • Legal product check & classification

    • Market potential analysis

    • Competitive analysis

    • Channel analysis

    • Portfolio review

    • Sales force controlling and management

    • Key account management

    • Investor search & market capitalization

    • Product strategy

    • Value pricing

    • Channel strategy

    • Strategic marketing

    • Point of sale promotional strategy

    • Key account management