Services available to clients
Pharma players – Just starting up, desire to expand their business in Regulated as well as Emerging Markets of the Globe.
- Smaller companies, seeking assistance to prepare themselves with Global Regulatory & GMP standards
- Looking for an assistance for product development and regulatory filings/ Handling the queries and Post approval amendments.
- Complete project management / coordination for the facility, QMS and implementation activities on behalf of client or its service providers.
- Compilation of eCTD dossiers and filing assistance using CESP and ESG for EU and FDA respectively.
- Vendor qualification audits, Follow up audits and evaluations at suppliers
- Third party assurance with capable resource available in USA, for USFDA liasonig and coordination.
- Medical Devices ISO 13485 audit and compliance support
- Support on outsourcing of Regulatory affairs and Quality Compliance function and substantially reducing financial burden of client due to Non compliance issues and remediation activities.
