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Regulatory Consulting

Tridents regulatory consulting arm provides strategic technical and operational advice to clients across the biopharma development life cycle. We provide an integrated approach to problem solving across the pharma value chain, from early development to launch. This integrated approach allows us to offer our clients solutions that reduce time to market, increase efficiencies and maximise their Return on Investment (RoI). Our consultants have 40 plus years of experience in dealing with regulators and payors, and we always taking a patient-centric view to any projects we undertake.

Our team has a wide range of experience, including clinical development, regulatory, non-clinical, and chemistry, manufacturing and controls (CMC). We can develop product development plans and help ensure that management teams have an optimized view of their asset’s development timeline, which helps manage risk from a supply chain, launch, pricing and compliance perspective.

Regulatory Strategy

  • We help sponsors mitigate risks by helping build a bespoke regulatory strategy that fits their Therapeutic Area (TA) and market needs. This includes assistance with scientific advice, briefing documents, and agency interactions, as well as liaising with commercial and development teams to optimize road maps, manage submission processes and prevent registration drift, i.e., PRIME, Parallel Advice, ODD, PIP/PSP, Pre-IND, Pre-NDA

  • Gap Analysis and Due diligence support

  • Product positioning from an integrated product development perspective relative to competitors (supporting Medical Communication strategy)

  • Regulatory pathway determination globally in conjunction with market access

  • Submission forecast and planning

2

Regulatory Submissions

  • FDA, EMA (MRP, DCP, CP, TGA AND MENA (GCC submission support). This includes pre- and post-approval activities for MAA / NDA /ANDA / BLA / IND.

  • Medical device dossier preparation and submission (CE marked technical files)

  • Clinical trial submissions (IMPDs, CTA via local and regional/harmonized procedures)

  • Label change tracking and artwork management

  • Change control management

3

Regulatory Operations

  • TBS regulatory operations team helps to build, submit and manage the full life cycle of a dossier in eCTD format for all ICH regions

  • Submission planning and tracking with governance and oversight

  • Formatting, meta data QC, bookmarks, hyperlinking and PDF renditions according to “house” styles. We work with a wide variety of RIM and Publishing suites and can adapt to client needs as appropriate

4

Regulatory Intelligence

  • We have a robust network across the globe in established and emerging biopharma markets to help clients keep abreast of the ever-changing regulatory landscape.

  • Local market / agent requirements globally, i.e., legal representative services in EU, Legal affiliate in MENA (GCC)

  • Business Intelligence on regulatory requirements – including submissions for clinical trials, marketing authorizations, post-marketing maintenance, and understanding global and regional regulatory requirements

  • Reports on current trends – including regulatory operations, interpretation of regulatory information to improve processes and KPIs

  • Product categorization & classification

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