Global Regulatory Affairs

Global Regulatory Affairs

Accelerate Approvals with Strategic Regulatory Leadership and Execution

Drive the development of your products – from preclinical proof-of-concept candidates to approved products primed for post-marketing label extension and regulatory maintenance – by partnering with an experienced partner who knows how to help you reach your long-term commercial goals.

Our highly skilled team of global regulatory experts are available to provide guidance and support for your products at any stage of clinical development for drugs and medical devices.

“Partnering with our clients in all stages of their product development programs and product lifecycle to accelerate global therapeutic development and enable access to the market”

  • Non-Clinical
  • CMC
  • Clinical
  • Pediatric
  • Orphan Medicines
  • Advanced Therapy Medicinal Product (ATMP)
  • Genetically Modified Organism (GMO)
  • Medical Devices & Diagnostics
  • Combination Products

  • Global, regional and country-specific regulatory plans to support the product development process including marketing authorisation pathways
  • Gap analysis and due diligence assessment
  • Review and creation of clinical development plans and Target Product Profiles (TPP)
  • Assessment and acceptability of clinical trial design and accepted end points to regulatory agencies
  • Engagement in early dialogue with regulatory agencies
  • Strategic guidance responding to queries from regulatory agencies
  • Considerations for pediatric plans, orphan drug designations and fast track designations
  • Development of product information/ labelling creation and Company Core Data Sheets (CCDS)

  • Fast Track, PRIME, Breakthrough designation, Regenerative Medicine Advanced Therapy (RMAT) & Qualified Infectious Disease Product Designation (QIDP)
  • Orphan drug applications
  • Pediatrics plans
  • Accelerated approvals, conditional marketing authorization and marketing authorization under exceptional circumstances
  • Priority reviews and accelerated assessments
  • Compassionate use programs/ expanded access programs
  • Advanced Therapy Medicinal Product (ATMP) classification and certification
  • Biomarker qualification

  • Protocol assistance, scientific advice and pre-submission meetings with regulatory agencies
  • Development of briefing documents and meeting materials
  • Meeting requests, rehearsals and facilitations
  • Meeting minutes and post-meeting follow-ups

  • Document development, e-publishing and submission of clinical trial applications including:
    • Modules 1 through 5 for US IND as per the ICH eCTD specifications to the FDA
    • Investigational Medicinal Product Dossier (IMPD) for EU CTA and UK CTA
  • Review and/ or development of Quality Overall Summary (Module 2.3), Non-Clinical Overview (Module 2.4), Non-Clinical Written and Tabulated Summaries (Module 2.6), Clinical Overview (Module 2.5), Clinical Summary (Module 2.7)
  • Review and compilation of Non-Clinical and Clinical literature references (Module 2, 4 and 5)
  • Review and compilation of technical CMC, Non-Clinical, Clinical documents for Module 3, 4 and 5
  • Assistance in responding to questions from regulatory agencies during submission review

  • NDA/BLA/MAA compilation, e-publishing and submission of the Common Technical Document (CTD) Modules 1 through 5, as per the ICH eCTD specifications to the regulatory agencies
  • Assistance in preparation of region-specific documents for Module 1 including product information
  • Review of Quality Overall Summary (Module 2.3), Non-Clinical Overview (Module 2.4), Non-Clinical Written and Tabulated Summaries (Module 2.6), Clinical Overview (Module 2.5), Clinical Summary (Module 2.7)
  • Review and compilation of Non-Clinical and Clinical literature references (Module 2, 4 and 5)
  • Review and compilation of technical CMC, Non-Clinical, Clinical documents for Module 3, 4 and 5
  • Assistance in responding to questions from regulatory agencies during submission review

  • SAE reports submission
  • DSUR/PSUR reports submission
  • Global submission annual reports
  • Submission amendments, variations and supplements
  • Investigator Brochures (IB) development and annual updates
  • Orphan Designation annual and maintenance reports
  • Pediatric Investigation Plans (PIP)/ Pediatric Study Plans (PSP) development, modifications and compliance checks
  • EMA authorized representative for non-EU established sponsors
  • US agent/ authorized representative for non-US established sponsors

  • Regulatory strategy development and pathways to market
  • Consultancy services and support throughout the product life cycle
  • Device classification determination, intended use statement development and predicate device determination
  • Pre-market, post-approval and post-market support
  • Appraisal and evaluation of technical documentation
  • Preliminary assessments, gap analyses and desktop audits
  • Technical files, design dossiers and quality system support
  • European authorized representation services and UK responsible person services
  • Notified Body discussions and pre-submission FDA meetings

  • Regulatory strategy development to facilitate path to market of combination products with drugs, biologics and medical devices
  • Assessment of the product’s primary mode of action (PMOA) and determination of product’s classification and regulatory pathways
  • Gap analysis to fulfill applicable regional and country-specific regulatory requirements
  • Guidance to create an integrated clinical and regulatory strategy to enable product development to meet clinical milestones
  • Scientific and strategic support for regulatory document development and interactions with Regulatory Authorities and Notified Bodies