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Integrate Regulatory Intelligence

Regulatory work can be cumbersome. We have simplified the process through automated tools for submissions and reporting. TrominoSoft provides regulatory operations services to Pharmaceuticals (FP and API), Biopharmaceutical, and Healthcare organizations.

We support regulated and semi regulated markets for submission in electronic format (eCTD, and NeeS format).

TrominoSoft’s regulatory team has more than a decade of experience in handling submission management/planning, publishing strategy, pdf rendition, submission level publishing (SLP), submission to regulatory authorities, archival and life cycle management.

Our Regulatory team provides consulting for:

  • eCTD Submissions
  • Establishment Registration
  • Self Identification of Facility
  • Structured Product Labeling (SPL)

eCTD Submissions

The Electronic Common Technical Document (eCTD) is a standard format for submitting applications, amendments, supplements, and reports to various regulatory agencies. The Non-eCTD Electronic Submissions (NeeS) format still exists in a few countries across the European Union and Gulf Cooperation Council.  

With an extensive knowledge of global regulatory publishing trends and submission formats TrominoSoft supports multi-country filings, data compilation, data publishing, and dossier submissions. For faster, compliant, and error-free submissions, TrominoSoft offers an industry recognised eCTD publishing and submissions software that adheres to all the regional regulatory requirements and International council of Harmonization (ICH) standards.

Trominosoft can support the global eCTD submissions formats such as Food and Drug Administration (FDA) USA, European Medicinal Agency (EMA), Health Canada, Swiss Medic, Saudi Food and Drug Administration, Ministry of Health (MOH) – Oman, Jordan Food and Drug Administration (JFDA), Thailand Food and Drug Administration, Australian Therapeutic Goods Administration (TGA), South African Health Products Regulatory Authority (SAHPRA).

Establishment Registration

Drug Establishment Registration, also known as FDA registration, is a mandatory annual requirement for facilities involved in the manufacturing, propagation, testing, and packaging of finished and bulk drugs, including generic, prescription and OTC drugs, both domestic and foreign import. TrominoSoft will manage the annual registration process, eliminating the possibility of rejection due to missing/invalid data or expired time limit.

Self-Identification of Facility

The manufacturer or any company who plans to become a  manufacturer of human generic drug APIs or Finished Dosage Forms (FDFs) are required to  submit “self-identification” information to FDA annually. Any organization or company that  package the FDF of human generic drugs into the primary container/closure system will also  have to go through this process and TrominoSoft will handle the process, adhering to FDA  guidelines.  

Structured Product Labeling (SPL)

SPL is a markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.

Structured Product Labeling (SPL) in XML format is mandated by FDA. Applicant must submit SPL in XML format in labeling section with PDF and Word documents for ANDA, NDA, and BLA submissions.

TrominoSoft Regulatory Labeling provides qualified expertise and teams who have specialization in conversion of FDA compliant & validated SPL files (XML) using package insert / medication guide and manages life cycle of SPL i.e., version control by using all the standard parameters as per FDA specification with complete validation.