Our services for biotech products

We will accom­pany your biotech product through all stages up to the successful autho­ri­sa­tion – and beyond. No matter whether you have ques­tions about the imple­men­ta­tion of GMP require­ments, method devel­op­ment or your clin­ical devel­op­ment programme, or need the services of a Qual­i­fied Person (QP) for the release: we will help you create the neces­sary docu­men­ta­tion and appli­ca­tions and will take care of contacting the author­i­ties for you.

Product devel­op­ment

  • Regu­la­tory and strategic consulting
  • Formu­la­tion development
  • Imple­men­ta­tion of the QM system and consul­ta­tions on GxP aspects
  • batch release accounted for by Qual­i­fied Person (QP)
  • Supplier audits
  • Compre­hen­sive labo­ra­tory services incl. stability testing in accor­dance with ICH guidelines
  • Prepa­ra­tion of briefing books and coor­di­na­tion of scien­tific advice discus­sions with the authorities
  • Commu­ni­ca­tion with the compe­tent authorities

Clin­ical and preclin­ical development

  • Coor­di­na­tion of our part­ners for preclin­ical and clin­ical development
  • Creation and submis­sion of IMPDs and INDs for clin­ical trials
  • Manu­fac­ture, testing and release of clin­ical batches

Dossier and marketing authorisation

  • Prepa­ra­tion and submis­sion of dossiers for the inves­ti­ga­tional medi­c­inal product (IMPD, IND)
  • Commu­ni­ca­tion with the authorities
  • Consul­ta­tion in marketing autho­ri­sa­tion procedures
  • Creation of marketing autho­ri­sa­tion dossiers in eCTD format
  • Appli­ca­tions for marketing autho­ri­sa­tions and processing of RFIs and defi­ciency letters
  • Project and process management
  • GxP audits

Life cycle management

  • Updating of dossiers, vari­a­tions, renewals, line extensions)
  • Quality manage­ment (e.g. audits, QMS update, PQR)
  • Labo­ra­tory services (e.g. release testing)
  • Phar­ma­covig­i­lance
  • Provi­sion of QPs or QPPVs
  • Review and release of adver­tising materials
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