Confidence Beyond Compliance

Scientific Services

  • Medical Information Services
  • Promotional Material Review
  • Product Monographs
  • Scientific Publications
  • Scientific Officer / Information Officer

Medical Writing

  • Preparation of Clinical Trial Protocols, Investigator’s Brochure, IMPD for Clinical Trial Applications in the EU
  • Preparation of non-clinical (M 2.4, 2.6) and clinical (M 2.5, 2.7) parts of the CTD dossier for IND dossiers in the USA

Regulatory non-clinical writing (early new drug developments & LCM)

  • Study Designs for GLP and non-GLP toxicity studies, reviewing and preparations of protocols and study reports
  • Coordination of non-clinical CROs for the conduct of the complete set of non-clinical studies for First-in-Human clinical trials and CTD Module 4
  • Toxicological Expert Reports on Impurities, Excipients, Degradation Products

Regulatory clinical writing

  • Orphan Drug Designations for USA
  • Orphan Medicinal Product Dossier (EU / US)
    • Regulatory Strategy for Orphan Drug Status
    • Writing OMPD
    • Submission through IRIS portal at the EMA
  • Applications for PRIME, Accelerated Approvals, Break-through Designations, Compassionate Use Programs, Hospital Exemption (ATMPs)
  • Preparation of PIP, PIP waiver, deferral, PUMA, submission to PDCO, modification of PIP, compliance check
  • Briefing documents for regulatory authority meetings / scientific advice
    • Preparation of Briefing Documents
    • Accompanying client to authority, rehearsal
    • Presentation, discussion with authority members
  • Preparation of meeting minutes, response documents
  • Non-clinical (M 2.4, 2.6) and Clinical (M 2.5, 2.7) parts of the CTD dossier for Marketing Authorization Applications (EU), NDAs/BLAs to FDA according to NtA Vol 9B
  • Integrated summaries of safety and effectiveness (ISS / ISE)
  • Environmental risk assessments/Environmental Assessments (EU / USA)
    • Bibliographic preparation of the ERA
    • Organisation of sales data for generic products
    • Scientific Advice at national authorities for discussing ERA strategy, Phase I and Phase II environmental studies, timelines
    • Study monitoring of Phase I and Phase II environmental studies, as requested by authorities
  • Labeling/CCDS preparation

CMC / quality writing for regulatory submissions

  • Global market applications (e.g. MAA / BLA / NDA)
  • Lifecycle activities (CMC variations, changes, annual reports, MA renewals)
  • IMPD for Clinical Trial Applications in the EU and USA
  • Briefing documents for regulatory authority meetings / scientific advice
  • Chemical & biological pharmaceuticals, e.g. biotechnology-derived molecules (e.g. mABs, fusion proteins, biosimilars), ATMPs, ADCs, herbals

Writing for Veterinary Medicinal Products:

  • Veterinary drug development
    • Application for Minor Use Minor Species (MUMS)
  • Environmental Risk Assessment report
  • User Risk Assessment report
  • Residue Study Report
  • Antimicrobial resistance report (including antiparasitic drugs)
  • Statements on quality, safety or efficacy for different purposes and requirements
  • Writing dossiers for the Marketing Authorization (MA) process (Parts I to IV according to NtA Vol 6B),
  • Scientific Advice meetings with competent Veterinary Health Agencies worldwide
  • Support of entire product lifecycle, including Renewals, Variations and Pharmacovigilance activities

We have a wealth of experience in supporting clients through the development of medicinal products, medical devices, consumer healthcare products as well as veterinary products.

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