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Home > Our Services > Scientific, Regulatory and Technical Writing

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.

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Thought Leadership

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Fact Flyers

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Case Studies

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  • Portfolio Maintenance Outsourcing – Global RA responsibility
  • Strategic outsourcing of mature product portfolio
  • Global CMC responsibility during portfolio integration
  • End-2-end portfolio maintenance (outsourcing) program
  • Post–M&A PharmaLex program governance
  • Post–M&A pharma infrastructure development
  • Regulatory CMC compliance reduced workload by 20-25%
  • Regulatory publishing support on request
  • Strategy and delivery of global biosimilar development program
  • ERA for an active substance in antiseptic lozenges

White Papers

  • Considerations When Applying for a Generic Medicine Authorisation
  • When your notified body is losing its designation under the medical device regulation
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  • The Medical Literature Monitoring of the EMA
  • Monitoring Compliance with Safety Exchange Agreements
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Webinars

  • SAP S/4HANA Validation: A Streamlined Approach
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  • Medical Device Risk Management for Patient and Product Safety
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  • Emerging Markets: LATAM
  • Achieving and maintaining REG CMC Compliance
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Infographics

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  • INTEGRATED PRODUCT DEVELOPMENT (IPD)
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What our clients say

In these unprecedented times, PharmaLex continues to support all clients by meeting virtually and providing experienced, remote-based consultants.

PharmaLex Team Thomas
Thomas Dobmeyer, CEO PharmaLex
CEO PharmaLex

They are available when we need to talk to them despite any time zone differentials

Japan based medium sized company
Manager

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Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.

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