Scientific, Regulatory and Technical Writing

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.