KelPharma offers a complete regulatory affairs support service, from early product development until life cycle management of the product. Our regulatory team are experts in Regulatory Affairs for the generic pharmaceutical industry.
We offer a wide range of regulatory services to the pharmaceutical industry aiming to meet our client’s requirements with full satisfaction.
- Product development
Our team will advise you from the early stages of the product development until you get the approved marketing authorisations. Current pharmaceutical regulations are very stringent and they are affecting on all areas of drug development, as such our team are highly experienced and can guide you on each and every stage of the product development.
- Regulatory Activities
- Writing & building dossiers
- Submitting and managing National Procedures
- Submitting and managing Decentralised Procedures (DCP)
- Submitting and managing Mutual Recognition Procedures (MRP)
- Performing due diligence and GAP analysis activities on underdevelopment or new products
- Post-Approval Management of Marketing Authorisations
- Variations
- Renewals
- Change of Ownership Application
- Clinical and Nonclinical Services
- Pre-submission documentation:
Clinical Study Protocol (BA/BE and Clinical trials)
Investigator Brochures
Patient Informed Consent Forms/Patient Information Leaflets
Patient Narratives
Clinical Study Reports (ICH E3)
Clinical Sections of Common Technical Document (Module 2.4, 2.5, 2.6 and 2.7)
Generate Labelling & PI - Post-submission documentation:
Aggregate Reports (DSURs, PSURs)
Update Labelling & PI - Medical Devices:
Clinical Evaluation Reports
Instructions for Use (IFU)