Our Regulatory Affairs function: made-to-measure advice for all client requirements

The Biofarma Group’s Regulatory Affairs function puts its expertise at the service of our clients, helping them comply with the applicable regulations for the various product categories.

Our team of highly-qualified experts provides customised regulatory packages that meet the needs of companies that intend to obtain and maintain the authorisation required to place their products on the market.

Our services range from satisfying single, specific requests to a fully-comprehensive advisory package.

Regulatory activities and functions

  • Preparation of technical files
  • Issuance of technical documentation for starting materials
  • Issuance of technical documentation for packaging materials
  • Development of category-specific Technical Files
  • Declarations of conformity with applicable regulations
  • Issuance of documentation required for foreign marketing authorisation applications

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