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We provide a wide range of services for regulatory projects such as;
- Registration of NCEs via Centralised, Decentralised, Mutual Recognition and National Procedures
- Preparation of Orphan Drug Applications
- In-licensing & Out-licensing
- Due diligence
- Training regulatory staff – Introduction to regulatory, mentoring and team support
- Writing Quality, Non-Clinical and Clinical summaries, overviews, expert statements
- Preparation and management of applications for Scientific advice EMEA or National
- Labelling and Compliance
We specialise in:
- Project Management and support to the generic and non-generic pharmaceutical industry.
- Global technical and regulatory consultancy. eg, setting up operations in EU.
- Total management of regulatory affairs.
- Dossier review
- Preparation and formatting to CTD
- Preparation of scientific and Expert Reports
- Data Gap Analysis
- Orphan products.
- All interactions with Regulators. Eg, scientific advice / responding to questions
- Risk Management
- Electronic data management
- Clinical Trials, GMP, GCP
- Manufacturing site QA reviews
- Inspection readiness and Pre-inspection audits
Our Supply Chain Services:
- Supply chain analysis
- Outsource management
- Procurement planning
- Fully compliant electronic service capacities