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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Related Services
- ANDA Withdrawals
- Clinical Trial Applications
- Digital Health Teaser Tool
- Global Procedure Management
- Health Authority / Agency Interaction
- Healthcare Compliance and Medical Approval
- INTEGRATED PRODUCT DEVELOPMENT (IPD)
- MAA / NDA Submissions
- Marketing and Labeling Activities
- Regulatory Operations
- Scientific Advice
- SMART MDR Teaser Tool
- SMARTCHECK
- SMARTCHECK MDR
- SMARTCHECK-MDR
- SMARTDECISIONS
- SMARTPHLEX
- SMARTTRACE
- Tobacco and Vape Products
- Toxicology Services
What our clients say
In these unprecedented times, PharmaLex continues to support all clients by meeting virtually and providing experienced, remote-based consultants.
CEO PharmaLex
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