RLDs/Innovator/Comparator sourcing

Reference Listed Drugs (RLDs) or Comparator Products Samples:

Tactus group supplies Branded, Generic, Specialty, Controlled substance and Bio-similar pharmaceuticals products from USA, Europe, Japan and other countries through our strong network of suppliers and deliver cost-effective and high-quality Pharmaceuticals. Sourcing and securing best shelf life of products with sequential and specific lots, Proper Documentation for Import/Export, customized sourcing of RLDs in small and large quantities.

Our services include:

  • 1. Sourcing and Procurement of Pharmaceutical Innovator/RLDs for development of Abbreviated new drug application (ANDA)/Generic applications for Regulated market
  • 2. Full support for REMS, Specialty, Bio-similar and Controlled substances.
  • 3. We help in sourcing of all dosage form include Tablet, Capsule, Injections, Granules, Powder, Creams, Diluents, Eye drops, Nasal sprays etc.
  • 4. Sourcing of Specific lot, Expiration date and self-life requirements.
  • 5. We ship the products under controlled temperature.
  • 6. Handling Small as well as larger quantities as per customer requirements.

Regulatory Services

We can help with your regulatory strategy, no matter what market you work in. Our Regulatory strategy team have deep capabilities required to complement your in-house team and deliver strategies to support the successful commercialization of products portfolios. We have work closely with all Regulatory agencies over many years – That allow our clients to flexibly approach any market and confidentially comply with regulations.

We regularly help clients develop and implement strategies for following activities:

  • Global Regulatory support.
  • DMF compilation and review.
  • Regulatory Affairs and CMC strategic guidance.
    (e.g. Labeling, clinical trials, BA/BE study monitoring and protocol design, Stability studies, Launch planning)
  • Module writing 2.4-2.7 for all markets.
  • Dossier compilation and review for Global market. (USA, Europe and others)
  • New product development strategy and filing strategy.
  • eCTD support and online Dossier filing to MOH.
  • EU and USA local agent and office support.
  • IPR Support with strategy.
  • Gap analysis and due diligence of Dossier for Merger and acquisitions related regulatory issues.
  • GMP Audits. (API & FDF GMP sites Audits)
  • User testing activities for EU submission.
  • SOPs preparation and QMS set-up.
  • Deficiency response drafting and submission in eCTD.
  • Support in product life-cycle management from development to launch activity.
  • ANDA/NDA/MAA site transfer activity and alternate vendor filing strategy.

In/Out Licensing of Pharmaceutical Products

Our Competitive Edge:

  • Generate lead through market connections.
  • Short listing of products through market survey and analysis of products.
  • Provide guidance on life cycle management, commercial aspects, and Investment of products.
  • Establish connections with Key Opinion leaders.
  • Due Diligence through available data.
  • Negotiations of financial terms for different stages of life cycle of product.
  • Establish an Agreement (CDA / NDA/MSA).