Regulatory Affairs Services
We offer regulatory support for human medicinal products, veterinary medicinal products and herbal medicinal products in Europe. Our objective is to achieve the fastest approval at minimal costs.
Drug Substance Services
- Development (writing) of ASMF/EDMF and US-DMF
- CEP applications
- Life cycle management — variations, revisions, renewals.
Drug Product Services
- Product development/regulatory strategies
- Pre-submission and/or scientific advice procedures
- Dossier evaluation and gap analyses
- Writing chemical-pharmaceutical documentation (CMC, Module 3)
- Compiling pharmacological-toxicological and clinical documentation
- Writing quality overall summaries (pharmaceutical-chemical expert reports)
- Preparation and submission of all types of Marketing Authorization Applications — national, centralized (CP), decentralized (DCP) and mutual recognition procedures (MRP)
- Preparation of SmPC, patient information, labeling
- Lifecycle management — adherence of regulatory compliance, variations, renewals, line extensions
- eCTD in-house publishing.
Our team of highly qualified regulatory affairs personnel includes pharmacists, biologists and chemists. We have expertise covering therapeutic areas such as CNS, eye care, oncology, urology, gynecology, gastro-enterology, cardiology, including different pharmaceutical forms such as oral, parenteral and sterile topical formulations. We regularly assist small, mid and big pharma customers with our regulatory affairs services.