Regulatory Affairs and Medical Affairs: Services beyond the ordinary!
We offer comprehensive regulatory/ medical support for human medicinal products, veterinary medicinal products and herbal medicinal products in Europe. From dossier compilation to registration and later life cycle management activities, our business-minded team ensures high quality work, but also keeps an eye on the implications for costs and time.
Our objective: The fastest approval at minimal costs.
Our Service for Drug Substance contains:
- Development (preparation) of ASMF/EDMF and US-DMF
- CEP applications
- Life cycle management — variations, revisions, renewals
Our Service for Drug Product contains:
- Product development/ regulatory due diligence (also related M&A transactions)/regulatory strategies
- Pre-submission and/ or scientific advice procedures at regulatory authorities
- 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, submission and management of all types of Marketing Authorization Applications — national, centralized (CP), decentralized (DCP) and mutual recognition procedures (MRP)
- Approval procedures, in particular Mutual Recognition Procedures (MRP) and Decentralised Procedures (DCP) - for convenient processing via an external approval holder
- Attractive submission deadlines (time slots) to regulatory authorities in the European Union
- Preparation of product information (PI) - SmPC, patient information, labeling
- eCTD in-house publishing
Our team of highly qualified up-to-date regulatory affairs personnel includes pharmacists, biologists and chemists.
We have expertise covering a variety of therapeutic areas such as CNS, eye care, oncology, urology, gynaecology, 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.