International Marketing Dossier & Compliance

“Success Depends on Building Trust Across Borders”
At Tagen Pharmaceuticals we believe that rapid technological advances mean that geographical and cultural communication barriers are disappearing, and even smaller businesses without a physical presence in other countries can market and sell their products internationally.
International expansion is one obvious way businesses can increase sales: New markets lead to new customers. For many, introducing products and services in global markets is not only increasing revenue, but also providing positive returns quicker than expected.

Personalization creates connection
There is a famous quote by anti-apartheid revolutionary and political leader Nelson Mandela: "If you talk to a man in a language he understands, that goes to his head. If you talk to him in his language, that goes to his heart". The first, most important step toward personalization is to transcend any language barriers. For international marketers to touch the hearts of their customers, employees or global partners, the communication must be localised and specifically tailored according to user's language, region and culture.

    Regulatory Strategies:
  • Preparation and submission of dossiers (Investigational New Drugs [INDs], New Drug Applications [NDAs], Abbreviated New Drug Applications [ANDAs], Marketing Authorization Applications [MAAs], New Drug Submission [NDS], Abbreviated New Drug Submission [ANDS], Drug Master File [DMF], Active Substance Master File [ASMF], Investigational Medicinal Product Dossier [IMPD]) for new and generic drugs
  • Preparation and submission of Biological License Applications (BLAs)/ MAAs for recombinant therapeutic proteins, vaccines and other biological products
  • Commercialization of advanced therapy products such as stem cells and cell-culture-based products
  • Drug launch from one market to another market
  • eCTD conversions and baseline submissions
  • Implementation of post approval changes
  • Identifying right strategies and mitigation plans for each case
  • Pre-submission interactions with HAs
  • Competitors landscape evaluation and preparation of right Regulatory strategies that suit well for product registrations ahead
  • Identification of right approach for each case/ clinical programs/ marketing authorization strategies
  • Support for Orphan Drug Designation (ODD) applications
  • Product evaluation for suitability under expedited programs, and Regulatory support for submission of expedited program requests
  • Identification of Regulatory route map for submission information about process, methods and other advanced technologies (e.g. gene sequencing techniques) that are proprietary in nature
  • Change in formulation/ route of administration of drugs and the registration of dossier to Health Authorities (HAs) (for example, 505b (2), hybrid applications etc.)

    Regulatory Consultation:
  • Quality by Design (QbD) protocols and reports
  • Evaluation of excipients against IIG data base
  • Protocols/ reports for process validation, method validations, specifications, test methods, exhibit batch protocols, pilot scale batches, commercial batch protocols etc
  • Defining the tests/ risk assessment for genotoxic impurities, elemental impurities
  • Stability study requirements considering bracketing and matrixing concepts
  • Reference Listed Drug (RLD) selection
  • Identifying the submission process in Europe
  • Selection of dissolution parameters multimedia
  • Support in RMS selection
  • Providing response to HA queries