Additional Specialized Services Offerings

We support with submission of Marketing Authorisation Applications globally.

We support with writing and review of CMC modules ready for submission.

With artificial intelligence you can translate a document within seconds. However, we support with technical-accuracy review to satisfy Health Authority expectations

• English
• Portuguese (including Brazilian-Portuguese)
• Spanish
• French
• Mandarin

We support with training your regulatory or cross-functional teams on diverse regulatory topics in general or tailored to your programs

• EU-CTR and UK clinical trial regulations.
• Other markets clinical trial regulations (US, China, Japan).
• Regulatory strategies applied globally.
• Regulatory intelligence.
• Clinical Development strategies.
• M&A and Divestments strategies.