Regulatory Writing / Scientific and Technical Writing

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.

Contact our specialists to tailor a service plan

    Add a header to begin generating the table of contents

    Areas of Expertise

    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

     

    CMC / quality writing for regulatory submissions

    • Global market applications and compilation of quality dossiers (ICH and non-ICH) (e.g. MAA / BLA / NDA, eCTD Modules 3 and 2.3 (Quality Overall Summary)
    • Local market applications (e.g. RU Normative document, BR Technical Opinion Document, CN Manufacturing and Testing Procedure)
    • ASMF / DMF and CEP submissions
    • Lifecycle maintenance activities (CMC variations, changes annual reports, MA renewals) and CMC compliance (e.g. GAP analysis, variations preparation, CMC dossier review and update)
    • IMPDs/INDs for Clinical Trial Applications in the EU and USA
    • Briefing documents for regulatory authority meetings / scientific advice
    • Responses to the deficiency letters support
    • Chemical & biological pharmaceuticals, for human and veterinary use, e.g. biotechnology-derived molecules (e.g. mABs, fusion proteins, biosimilars), ATMPs, ADCs, herbals, homeopathics, generics, medical devices and drug-device combinations

    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

    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

    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 offer global solutions covering the entire product lifecycle

     Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.

    Available Resources

    Related Services

    PharmaLex has long-standing and extensive experience of interacting with the scientific committees and working parties of the EMA (e.g. CHMP, PRAC, COMP, PDCO, CAT) and with national Health Authorities. We frequently support our clients in Scientific Advice procedures at a national or central level, and in numerous health authority interactions throughout a product’s lifecycle (e.g. requests for PRIME eligibility, Orphan Medicinal Product designations, Pediatric Investigational Plans, Marketing Authorization Applications).

    More Info

    With over 75 CMC consultants across the globe, PharmaLex has substantial CMC expertise across all areas. We are able to offer an integrated solution combining the scientific, technological, non-clinical, clinical and regulatory expertise with our broad global project experience to meet your specific needs, from discovery to licensing and post-approval.

    More Info

    CMC strategy and documentation plays an important role from early development to authoring of the marketing authorization application dossier. It also extends to change control and maintenance throughout the product lifecycle. Moreover, CMC requirements are complex and different for chemicals, biologicals, biosimilars, herbals or homeopathics. PharmaLex guides you to the best CMC approach for your products in line with health authority requirements and helps you to stay CMC compliant with sustainable processes.

    More Info

    Ensuring a smooth and effective submission process today goes beyond the old ways of eCTD publishing. For over 15 years, we have led the way in regulatory submissions with an evolving holistic approach that includes everything from planning to embedded quality control. Of course, all of our services are complemented by state-of-the-art digital facilitation.

    More Info

    Whether you are interested in outsourcing portfolio maintenance, require support during a merger and acquisition phase, need assistance covering your pharmacovigilance obligations or in development and implementation of your QMS—our Post-approval solutions provide trusted, strategic ways, as well as hands-on support, to keep your product compliant and moving forward.

    More Info

    Contact Us

    Contact Form

    Complete this form to stay in contact with us.

    Global Approach

    PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.

    Scroll to Top