Global Business Development

Our connect in 65+ Countries

  • Selection of countries on Phased manner
  • Country specific global regulatory requirements for Product dossiers & registrations.
  • Global plant audits trigger and approvals.
  • IP / Brand Ownership
  • Identification and selection of right product mix
  • Selection and appointment of right business partners / importers and distributors
  • Selection and appointment of local regulatory agent
  • Registration of overseas subsidiary company / representative office / branch office / local independent company
  • Selection and appointment of local team
  • Launch of company and products
  • Promotional strategies – pre, during and post launch activities
  • In licensing, Out licensing & Co development

Our Global Connect

Global Presence

Global Business Associates

For more info please write to

Product Development

  • Identification of right product
  • Project Management – Cost and timelines – Product development & fillings
  • Review, Report & Strategy for patents
  • Protocol and design of B.E. Studies and clinical trials
  • Identification, Audit and Management for purchases

Global Quality & Regulatory Compliances

  • To evaluate facility design and carry out gap analysis with mitigation plan.
  • To carry out Gap Analysis in existing pharmaceutical quality systems and to prepare mitigation strategy for necessary compliance.
  • To establish Quality Management Systems as per the requirements of international health authorities in order to obtain regulatory certifications from EU/US FDA/TGA, Australia/Medsafe New Zealand/HPB ,Canada.
  • To initiate registration of products in EU/USA/AUS/NZ/Canada and Rest of the world (ROW) in order to create intellectual property (i.e. MA/Product Licenses) and to enhance international business.
  • To provide regulatory support for site variation of identified products for respective countries to trigger regulatory inspections and to obtain approvals.
  • To develop & establish processes in Formulation & Analytical Development for robust technology transfer of products.
  • To impart training to all technical personnels in the organization to bring cGMP and regulatory awareness to gain confidence of international health authorities & Customers.
Facility Evaluation
  • Facility evaluation in line with international cGMP requirements.
  • Gap analysis in existing facility design and to prepare mitigation plan to bridge the gaps.
  • Evaluation of equipment design and material of construction as per process and cGMP requirements.
  • Evaluation of HVAC & Utility design to ensure aseptic process controls.
  • To evaluate competency of technical personnels on GMP & subject knowledge and to identify training needs with action plan.
Quality Management Systems
  • Quality Assurance
  • Warehouse (Raw/Packing Material/BSR)
  • Production (Dispensing/Manufacturing/Packing)
  • Quality Control (Chemical/Instrumentation/Microbiology)
  • Stability Section
  • Engineering & Utilities
  • Administration
  • IT (Information & Technology)
  • Formulation Development (As per QBD)
  • Analytical Development (As per QBD)
  • Regulatory Affairs
  • Safety & Environment
  • House Keeping (Cleaning & Sanitization)
  • Review of technical agreements
Regulatory Affairs
  • Establishment of Regulatory processes and systems for registration of products in developing and developed countries.
  • To provide country specific guidelines for registration of Dossiers, ANDA and ANDS fillings in UK, AUS, NZ, US, Canada and rest of the world (ROW).
  • Preparation of check list as per country specific requirements.
  • Preparation of dossiers in prescribed format.
  • Review of dossiers/ANDA’s for technical adequacy.
  • Response to the queries received from various health authorities.
  • Installation & Validation of eCTD software as per GAMP & 21 CFR part 11 compliance.
  • eCTD fillings (Dossiers, ANDA’s, ANDS)
  • Annual updates and notification of changes to various regulatory authorities.
  • Filling of type 1 and type 2 variations
  • Coordination with regulatory agents, distributors on technical matters and art work.
  • To ensure site variation (SA)documents for filling to health authorities.
  • Current regulatory updates and amendments
Formulation Development
  • To establish processes and quality systems in Formulation Development for robust product design with understanding of QBD concept.
  • Product development protocol and report.
  • Establishment of critical process parameters and critical control limits with justification.
  • Preparation of dossiers in prescribed format.
  • Designing of MPCR/BPCR.
  • Technology transfer protocol and report.
Analytical Development
  • To establish processes and quality systems in Analytical Development for robust method design.
  • Analytical method development protocol & report.
  • Analytical method validation protocol and report.
  • Development of method transfer protocol.
  • Review of method transfer report.
  • Designing of Specifications, Test Procedure, Test Protocol.
  • Development of Stability protocols as per ICH guidelines.
  • cGMP Training
  • Regulatory Guidelines
  • Good Documentation Practices
  • Good Warehousing Practices
  • Data Integrity
  • Risk Assessment & Mitigation
  • Root Cause Analysis
  • SOP Training
  • Validation Planning
  • Qualification of Equipments & Utilities
  • Process Validation
  • Cleaning Validation
  • Analytical Method Validation
  • Current Good Laboratory Practices
  • Change Control Management
  • Deviation Control Management
  • Complaint Investigations
  • CAPA Tracking