Our Company has expertise for managing liaison assignments in all sections of the Drug Department, working for varied manufacturers & importers. Needless to mention about clinical trial permissions & import permits coupled with related departments and ministries (such as DGFT, Animal Husbandry, and Ministry of Science & Technology). We generally look at the drug regulatory compliance from the angle of custom’s laws to avoid future complications. We ensure 100% compliance with the laws of the land and other International laws like FCPA.
We provide complete guidance for preparation of Dossiers. We are regularly retained to prepare dossiers for obtaining Manufacturing Licenses, GMP etc. from respective State Drug Controller & Regional CDSCO. We possess large number of briefs on Diagnostics & Medical Devices Regulatory.
We are into consultancy of getting various healthcare related accreditations such as NABH to hospitals, NABL to laboratories etc.
Services for Regulatory and Statutory Compliances (Approvals/ Licenses/ Permits)
- Special NOCs/ Waivers
- Testing: Form 11, NOCs
- Import Licenses, Registration
- Dual Use NOC for drug (bulk and finished form), cosmetics, medical devices and kits
- Change of Location
- Renewal of Licenses/ Extensions, Recertification
- Documentation and Preparation of Dossier
- Submissions at Regulatory Govt. Offices in State FDA, CDSCO- Central, Zonal and Sub Zonal Offices
- Submission of Govt. fee for various Licenses, NOCs and Permissions
- Submission, Meetings and Collection of Test Reports from Govt. Labs (NABL,CDTL/CDL etc)
- Technical and Regulatory Support for queries by Port Officers
- Permission from MoE, MoA, CIB, BIS
Pharmacovigilance Services
- Strategic and operational benefit/risk safety services
- Management of case reports and adverse event reporting, Individual Case Safety Report (ICSRs) Processing
- Post‐Marketing Non‐Solicited/Spontaneous Reports
Clinical Trial Reports
- Medical Device related Reports
- Special Reports: Pregnancy reports etc.
- Routine safety surveillance, signal detection and management
- Risk-benefit management and analysis
- Risk Management Plans (RMPs)
- Qualified Person for Pharmacovigilance (QPPV)
Medical Writing Services/ Clinical & Regulatory Writing Services
- Aggregate & Periodic Report Writing (PSURs/PBRERs/PADERs/DSURs) & Submission
- Pharmaceutical Risk Management Plans (RMPs)
- SAE Narratives for Clinical Study Reports
- Clinical Study Reports
- Clinical Summaries/Product Feasibility Reports for Medical Devices
- Annual safety report writing
- Patient Diary Cards (PDC), Informed Consent Form (ICF), Case Report Forms (CRFs)
- Company Core Safety Information (CCSI), Company Core Data Sheet (CCDS), Summary of Product Characteristics (SmPC), Pack Insert and Local Labels
- Detailed Description of Pharmacovigilance Systems (DDPS)
- Literature and Brochure for medical devices
- Creation of detailed NDA, ANDA and IND applications (Module 1,2,3,4 and 5)
Services related to Manufacturing License of Allopathic Drugs, Medical Devices and Cosmetics
- Manufacturing License/Loan License/Form 29
- GMP/WHO GMP Certificate
- Export NOCs
- Free Sale Certificate
- Neutral Code Certificate
- Advance License
- Site Audits
- Renewal of Licenses, Certificates
- R&D Recognition from DSIR
- Legalization from Embassy & Notarization (Whenever Required)