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

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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.