Services

Regulatory Affairs

EHS provides Regulatory Support to obtain EU registration. Our experience extends to the preparation of dossiers and drug master files and beyond for APIs, Pharmaceuticals and Medical devices.

Our expertise has a broad portfolio and coverage across all RA segments

• Advice on EU legislationAdvice on EU legislation
• Strategy for entry into Europe
• Orphan medicinal product designation
• Applications for EMEA and National Scientific Advice
• Support in obtaining Marketing Authorization: National Route, Mutual Recognition Procedure (MRP) or De-Central Procedure (DCP).

Scientific Data Assessment

• Assessment of data for suitability for registration
• Identification of deficiencies
• Regulatory and technical due diligence

Product Literature and Readability Testing

• SPC, PIL and Labelling Texts

Registration

• Writing chemistry/pharmacy (CMC),Preclinical and clinical modules
• Preparation of regulatory submissions for MAA
• Expert reports/overviews

Clinical Consultancy

• Clinical Trial Authorisations

Medical Devices

• CE Marking
• Product classification
• Preparation of technical files
• Risk assessments

International Regulatory Desk Research

• Identification of worldwide regulatory requirements
• On-line literature searches
• Pharmacovigilance

Chemicals

• Implementation of REACH regulations
• Chemical registrations under REACH project

Publishing and Submissions Management

• eCTD, non-eCTD electronic and paper submissions
• Standalone publishing or as part of integrated regulatory project management

Other Services

• Certificate of Suitability from EDQM
• In house regulatory support
• SOP writing & setting up QA Systems
• Auditing and Monitoring services.
• Implementation services (GMP).
• GMP Audits API suppliers and CMO’s