The regulatory environment varies from country to country. A comprehensive understanding of regulatory requirements, timelines and associated costs is required to enter the market.
A regulatory strategy aligns the regulatory activities to bring a new or modified product to market with the business strategy for that product.

We can help you to develop a global regulatory strategy:

• Clarify national registration requirements
• Determine application procedure
• Identify additional requirements, e.g. NRG application, letter of intent
• Negotiation with Health Authorities, e.g. pre-submission meetings

• Preparation of Marketing authorization applications in CTD and eCTD format for Switzerland, EU, US, CA, AU, JP, e.g.
  • CH: application for authorization
  • EU: national procedure, MRP, DCP, CP
  • US: NDA, ANDA, BLA
  • CA: NDS, SNDS
• Creation and submission of Core Dossiers for international markets
• Creation of Drug Master Files (EDMF, DMF)

• Initial applications
• Variations / Supplements / Change applications (NC, level II, PCA, Cat.C, etc.)
• US Annual Reports
• Line Extensions
• Renewals
• Periodic Safety Update Report (PSUR) submissions

• Establishing Drug Master Files for pharmaceuticals

• Specification of the organization and granularity of the CTD
• Creation of templates and boiler plates for dossiers, e.g. CTD
• Transposition of existing dossiers (e.g. Notice to Applicants) into the CTD format
• Specification of eCTD publishing requirements
• Preparation of documentation for publishing for electronic submissions

We provide training to your regulatory and non-regulatory staff

• Regulatory requirements in different countries
• Submission format and requirements
• Individual coaching