We can provide stand-alone regulatory documents, submissions (including e-CTD format) and presentations to support pre- and post-marketing activities in the biotechnology, pharmaceutical, medical device, food and cosmetic industries.

PHARMACEUTICAL & BIOTCHNOLOGY:

• Preparation of Investigational Medicinal Product Dossiers
• Preparation of Clinical Trial Applications, including protocol assistance
• Preparation of US Investigational New Drug (IND) Applications
• Preparation of CTA and IND Amendments and Serials
• Preparation of Developmental & Periodic Safety Update Reports (DSUR & PSUR)
• Preparation of MAA, NDA and BLA Applications
• Quality Overall Summaries, Non-Clinical and Clinical Overviews
• Responses to questions and appeal documentation
• Oral Presentations
• Scientific Advice Procedures (National / EU)
• Risk Management Plans
• Paediatric Investigation Plans
• Orphan Medicinal Product Requests
• Type IA, IB and II Variation Applications
• Market Extension Applications
• Renewal Applications
• Patient Information and User Testing


MEDICAL DEVICE:

• Preparation of Clinical Investigation Submissions (EU) and IDE Submissions (US)
• ISO 14971 Risk Management Plans
• CE Dossiers and Market Extension Applications
• 510K and PMA Applications
• Post-Marketing Surveillance Reports
• Drug / Device Borderline Petitions


FOOD & COSMETIC PRODUCTS

• Due Diligence Dossiers for EU Food or Cosmetic Law

Technical/Medical Writing

technical medical writing

Other Services

Other Services