Sirega - Services in Regulatory Affairs We are a regulatory affairs consultancy with 10 years professional experience in the pharmaceutical industry, especially in writing of CMC documentation. We cover all kinds of medicinal products and have specialized in Biotechnology and Advanced Therapies Medicinal Products. We offer the preparation of the Quality Parts of IMPDs/INDs according to the requirements for the different clinical phases: From first draft documents and gap analysis of existing documentation to submission ready documents.