Our core focus is to offer supportive services to Regulatory Departments of Pharmaceutical Companies in the field of Registering Pharmaceutical Dossier Writing. We are having been involved with all aspects of regulatory affairs, from supporting Clinical trials, bioequivalence reports, validation data, Expert reports, Data for Overview, PSUR through registration activities, compilation of Pharmaceutical dossier / application for registrations of medicines and E-Filings to post-marketing regulatory obligations for Pharma Industry. We can provide the following services to our Manufacturer’s
- Assisting in Preparation of Dossiers in eCTD Format
- Preparation of dossiers for Indian regulatory authorities
- Post approval regulatory & Pharmacovigilance support
- Maintaining Confidentiality
- Timely updating clients with new rules and regulations updated by the authorities.
- Having a systematic process for Registration:
Process 1 |
Preparation of Dossiers & Documents |
Process 2 |
Reviewing of Dossiers & Documents |
Process 3 |
Payment of Registration Fees |
Process 4 |
Submission of Documents |
Process 5 |
Samples Submission in Central Drug Laboratories |
Process 6 |
Solving Queries Raised by Authorities |
Process 7 |
Obtaining Registration Certificate. |
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Services