We at NexusCRO, also provide consultation to our clients on :
- Methodology to approach the regulatory bodies.
- Regulatory submissions / Product registration dossiers.
- Time management (Faster Regulatory Approvals).
- An initial assessment of your data to maximize the possibility of rapid clinical trial approval
- Preparation of Regulatory Dossier.
- Regulatory strategy planning for faster approval.
- Filing of submissions, tracking submissions & query resolution.
- Post - approval regulatory submissions (amendments).
- Submission of final study reports.
- Preparation and submission of Product Registration applications, to import, manufacture and market in India.
- Complete Import & Export License Management for clinical supplies and biological product and samples.
- Collecting, reviewing and updating all national legislation related to clinical trials to ensure full compliance with all applicable.
- NexusCRO is familiar with Ethics Committee requirements. Its reputation for an active follow-up of protocol submissions ensures fast turn-around time.
- Familiarity with local requirements and practices is important in avoiding unnecessary delays when embarking on studies. With extensive experience in obtaining IRB/IEC approvals, NexusCRO professionals bring these assets to your clinical development programmes.
(Asiatic clinical)We support our client's product development programs by playing a pivotal role in obtaining regulatory approvals in the shortest possible time. We have a dedicated in-house regulatory team which assists in a broad range of Regulatory Consultations for most effective approvals and strategies. We cater from local to global submissions. Having a better understanding of the Indian regulatory scenario, we provide the best assistance to resolve any queries raised by the "Drug Controller General of India" (DCGI) and follow-up submissions for faster approvals.