Who we are
Our internationally experienced specialists have detailed know-how in the planning and preparation of dossiers, e.g. European ASMF (Active Substance Master File), US-DMF (Drug Master File), certificate of suitability (CEP). We prepare
regulatory documents for your global submission. For the start of the clinical trial the
CTA (Clinical Trial Application) needs to be submitted in EU, and the
IND (Investigational New Drug Application) needs to be submitted in US. These are the documents which we will be elaborated with you and will be written for you.
Once you have successfully gone through clinical trials we support you in the preparation of the CTD (Common Technical Document) for submission of the European
MAA (Marketing Authorization Application) and the US
NDA (New Drug Application) /
BLA (Biologic License Application).
Regulatory submissions entail a large variety of documents. We are here to advice you on how to structure and write these documents, and we are prepared to take up this task for you, e.g. SPCs (Summary of Product Characteristics),
clinical or
nonclinical study protocols and reports, clinical or non-clinical summaries and overviews, Quality Overall Summaries (
QOS) as well as
CMC documents.
We guide your project through the regulatory process, elaborate regulatory strategies for European and US-filings, and help you in the preparation of
meetings with Authorities (national agencies, EMA, FDA).
However, a successful submission also depends on compliance with
GMP /
GCP and
GLP standards. We check your compliance status during
mock inspections. We help you to ensure adherence to EU and US-requirements and support you in setting up adequate quality systems by writing SOPs and performing training for your personnel.
Whether you are a
pharmaceutical or
biotechnology company, an
API (Active Pharmaceutical Ingredient) manufacturer, contract manufacturer, contract laboratory,
SME (Small and Medium-sized Enterprise), medical device industry,
Advanced Therapy Industry (ATI), we will help you carry out both large and small
projects in all stages of the product lifecycle: in the pre-submission, submission, pre-approval, approval and post-approval phase.