Drugs for US
- NDAs
- ANDAs
- INDs
- DMFs
- Supplements to NDAs, ANDAs, DMFs
- Drug Product Listings
- Establishment Listings
- Preparation of facilities for Pre-Approval Inspections
- Assistance during the Inspection(s)
- Advice on how to handle changes to approved drugs
- Preparation of SOPs
- Assistance in Adverse Event reporting and recalls
- Annual reports
- Annual product reviews
- Internal Audits
- External Audits of contract manufacturers of APIs, excipients, components for container/closure, testing labs, sterilization facilities, etc.
- Technical advices on facility changes such as HVAC, testing equipment, sterilizer validation, equipment validation, stability programs
- Assistance in selection of contract manufacturers
Drugs for Non-US
- Same services as provided for US firms for drugs for US market
- Registration of drugs in the EU using the CTD format
- Registration of drugs in other countries, e.g. Canada, Central and South America