Technical
Services

    • Full-service management of new MA applications (CTD/ANDA/ACTD /DMF); CE Mark; UL Mark

    • Running of procedures for ANDA, and MRP/DCP, national phases

    • Review of active substance Drug Master File and actions closure

    • Delivery of non-clinical and clinical overview and summary

    • Management of post approval changes/variations, renewals and optimum strategies

    • SPC, R&D projects, and site transfer projects, regulatory planning for site and technology transfer projects; establishing, gathering, and compiling documents for filing variations and new sourcing strategies

    • Review and compilation of documents from R&D, Bioequivalence studies, API manufacturer and formulations manufacturing for NDA, sNDA, ANDA/eCTD readiness; 510K/CE/UL/ISO/IATF readiness, gap analyses and gap closure advisory.

    • Submission of eCTD for EU, ANDA’s for USA, or any other geographic filings.

    • Running Centralized procedures like Centralized/MRP/DCP (EU)

    • Advisory on optimum filing strategies to reduce approval time and costs, filings & queries management, with customer as front end

    • Guidance to R&D team during product development stages to ensure streamlined ANDA/eCTD/510K/CE/UL approvals

    • Screening of in-licensing dossiers for registration success

    • Coordination with Manufacturing, R&D, Quality, Artworks, Pharmacovigilance, and other functions for smooth integration of all ANDA/eCTD/510K/CE/UL documents to ensure regulatory compliances.

    • Regulatory budget setting and costing based on Client product pipeline plans.

    • 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 (such as Qualified Professional in EU) for effective Quality Management Systems (QMS) as mandated by regulatory bodies (such as FDA/ICH/EMEA/ISO).

    • QMS: Create, enhance, maintain End-to-end system aligned with all regulatory guidelines

    • Audits:

      • Conduct audits compliant with EDQM/USFDA guidelines, issue report that can be used in regulatory filings

      • Perform gap analyses, follow up with sites for corrective and preventive actions (CAPA) closure

      • Sites related to Formulations manufacturing, API, Formulation development, Device manufacturing, Clinical studies

    • Manufacturing Systems (contract or inhouse):

      • Creation, review of SOPs, Work Instructions, SMF, Technical Agreements, Process validation protocol, Specifications

      • Quality tracking with global manufacturers

      • Annual Product Quality Review (APQR), Complaints investigations, gap analyses, CAPA closure

      • Batch Release activities: Review of batch records (BMR/BPR); Third party lab coordination

      • Manufacturing Site Transfer: Review of alternate sourcing documents

    • Qualification & Validation:

      • Development of Qualification protocols; Review of User Requirement Specification (URS); Functional Design Specification (FDS) of equipment

      • Support in different Qualification steps i.e., FAT/SAT/DQ/IQ/OQ/PQ

    • Artwork development, working with manufacturers, maintenance via change controls

    • Regulatory/Certifications submissions: Quality sections for eCTD, ANDA, DMF, ISO, CE Mark, UL Mark

    • Formulation Development: Selection, audit of CDO facilities

    • Bioequivalence / Clinical Studies: Selection, audit of CRO facilities

    • 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

    • Identify sourcing of products/technologies driven by Business Development/Marketing

    • Create awareness of available new products and platforms with market potential

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

    • Access to R&D pipeline products

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

    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

    • Coordination of formulations, analytical and 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

    • Budgeting, success tracking, deliverables, risk management

    • Techno-commercial agreements, protocols

    • Work with regulatory for successful submissions, and supply chain for reliable supply

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

    • End-to-end supply chain management from PO placement to delivery with multiple partners

    • Commercial negotiations and techno-commercial agreements

    • Relationships Management, problem resolutions

    • Technical Sourcing: Formulations, Cost effective API, excipients, key intermediates, electronic items, molds, packing materials, capsules

    • Fast launch planning

    • Procurement of equipment for manufacturing and R&D

    • Establishing marketing tie ups with partners who have local presence

    • Provide inputs on acquisitions, own set up, evaluation of various scenarios, etc.

    • Risk assessment & mitigation strategies

    • Bulk formulation supplies with local packing strategies

    • Establishment of warehouse/Inventory management system

      CMO Management

    • Manage identification, qualification, and quotes from multiple CMO’s. approved by USFDA/EUGMP/1348/UL, including API and device components

    • Recommend to Client, help select a CMO, and provide CMO management oversight

    • Negotiate supply agreement and quality agreement on behalf of the Client

    • Qualification of CMO from screening, facility tours, system audit and review of following:

    • Create and facilitate estimation of Cost of Goods, commercial and technical agreements

    • 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

About us

Privacy Policy

Legal Details / Contact