Life sciences organizations must overcome significant challenges in managing Regulatory requirements through the drug lifecycle.

BCS have 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), FSSAI, and Ayush ministry and follow-up submissions for expedited approvals.

We support:

• NEW DRUG APPROVALS AND FIXED DOSE COMBINATIONS
• GLOBAL CLINICAL TRIALS
• BA/BE NOC
• POST MARKETING SURVEILLANCE STUDIES
• COSMETICS’ IMPORT REGISTRATION
• NUTRACEUTICALS/FOOD SUPPLEMENTS APPROVAL – FSSAI
• ETHICS COMMITTEE REGISTRATION

We also support:

• Regulatory strategy planning for faster approval
• An initial assessment of your data to maximize the possibility of rapid clinical trial approval
• Preparation of Regulatory Dossier.
• Filing of submissions, tracking submissions & query resolution.
• PSUR submissions
• SAE submissions
• Post – approval regulatory submissions (amendments).
• Submission of final study reports.
• Complete Import & Export License Management for clinical supplies, and biological products/ samples.

IRB/IEC Submissions:

• BCS is familiar with Ethics Committee requirements. It’s 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.

Field Studies & Pre-Clinical Services

Field Trials for Poultry:

Field research, field studies, or fieldwork is the collection of raw data outside a laboratory,  or workplace setting. Field research involves a range of well-defined, although variable, methods: informal interviews, direct observation, participation in the life of the group, collective discussions, analyses of personal documents produced within the group, self-analysis, results from activities undertaken off- or on-line, and life-histories. BCS field research typically involves studying of free-living wild animals in which the subjects are observed in their natural habitat, without changing, harming, or materially altering the setting or behavior of the animals under study. When conducting field research, keeping an ethnographic record is essential to the process. Field notes are a key part of the ethnographic record. In BCS, the process of field notes begin as the researcher participates in local scenes and experiences in order to make observations that will later be written up.

Pre-Clinical Services:

BCS has a strong hold in providing Pre-Clinical Services, including but not limited to, the studies of poultry & piggery diseases, nutrition, virology, poultry production, immunology, genetics, parasitology, reproductive physiology, neurobiology/physiology, microbiology and food safety and enhancement of breeder/broiler flocks, with all the necessary Regulatory and Ethics Committee approvals.