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
- Medical Information Services
- Promotional Material Review
- Product Monographs
- Scientific Publications
- Scientific Officer / Information Officer
- 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
- 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
- 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
- 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
- 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
- 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
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.
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PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.