500+ Clients
20+ Years Experience
CDSCO Experts
Pan India Support
BIOLOGICAL SERVICES

Quick Snapshot

  • Services:
    • IBSC Formation & Management
    • RCGM Regulatory Submissions
    • Biosafety Compliance Support
    • Portal Registration & Management
  • Who We Support:
    • Research Institutions
    • Biotechnology Companies
    • Startups
    • CROs & Biopharmaceutical Companies
  • Key Activities:
    • Biosafety Assessments
    • Regulatory Submissions
    • Committee Documentation
    • Compliance Management

R & D of Biopharmaceuticals

We provide regulatory, biosafety, and documentation support for biopharmaceutical R&D programs involving biologics, recombinant DNA (rDNA) research, genetically engineered organisms, cell and gene therapies, and advanced biotechnology applications. Our services help organizations establish appropriate biosafety governance and prepare regulatory documentation aligned with Indian biotechnology regulations and international biosafety expectations.

Biosafety Governance and Expert Support

Structured support for institutional biosafety committee management and qualified biosafety and scientific expert coordination.

Institutional Biosafety Committee Formation & Management
  • Establishment and constitution of the Institutional Biosafety Committee
  • Preparation of committee charter, policies, and standard operating procedures
  • Support for IBSC constitution requirements, including guidance on required committee composition and coordination with relevant stakeholders for regulatory compliance
  • Committee governance and operational support
  • Ongoing compliance management and regulatory oversight
Biosafety and Regulatory Expert Management
  • Identification and engagement of qualified biosafety and scientific experts
  • Coordination with qualified biosafety and scientific experts in areas such as virology, genetic engineering, molecular biology, containment systems, and biotechnology
  • Expert review of research projects and biosafety assessments
  • Continuous regulatory guidance and compliance support

Our Approach What You Will Get (Deliverables)

Structured support for a smooth and compliant cosmetic manufacturing license process.

Institutional Biosafety Committee Meeting Documentation
  • Planning and coordination of committee meetings
  • Preparation of complete and regulatory-compliant Minutes of Meeting
  • Documentation of project reviews, biosafety evaluations, and committee decisions
  • Recording of recommendations, approval conditions, and voting outcomes
  • Maintenance of audit-ready records and documentation
Biomedical Research and Regulatory Portal Registration
  • Biotechnology regulatory portal registration and management support
  • Creation and management of investigator profiles
  • Registration and onboarding of Institutional Biosafety Committee members
  • Research project registration and generation of project identification numbers
  • Ongoing portal administration and compliance support

Review Committee on Genetic Manipulation Regulatory Submissions

Comprehensive regulatory support for biotechnology, biosafety, and genetic manipulation submissions.

RCGM Regulatory Submissions
  • Preparation of regulatory applications and supporting documents
  • Submission of applications to the Review Committee on Genetic Manipulation
  • Support for recombinant deoxyribonucleic acid research approvals
  • Assistance with genetically modified organism import and export approvals
  • Support for regulatory documentation related to large-scale biotechnology production activities and approvals where applicable
  • Regulatory support for gene therapy, cell therapy, and advanced biotechnology research programs
  • Preparation of responses to regulatory authority queries
  • Submission tracking and compliance management
  • Support for compliance with applicable biotechnology and environmental regulations
  • Dedicated support throughout the regulatory process
Why Choose Us?
  • End-to-End Regulatory Support
  • Experienced Biosafety & Regulatory Experts
  • Audit-Ready Documentation
  • Compliance with DBT, RCGM & Biosafety Requirements
  • Support for Academia, Startups, CROs & Biopharmaceutical Companies

FAQ

Frequently Asked Questions

01
What types of research projects do you support?

We support biologics, rDNA research, GMOs, gene therapy, and advanced therapy projects.

02
Can you help establish an IBSC?

Yes. We provide support for IBSC formation, documentation, and ongoing compliance management.

03
Do you assist with RCGM submissions?

Yes. We prepare and manage regulatory submissions and authority interactions.

04
Can you support biosafety compliance activities?

Yes. We assist with biosafety assessments, documentation, and regulatory compliance requirements.

05
Do you manage biosafety committee documentation?

Yes. We support meeting coordination, minutes preparation, and record management.

06
Can you help with regulatory portal registrations?

Yes. We assist with institutional, investigator, and project registrations.

07
Do you provide expert biosafety guidance?

Yes. We work with qualified biosafety and scientific experts across biotechnology disciplines.

08
Who can benefit from these services?

Research institutions, biotechnology companies, startups, CROs, and biopharmaceutical organizations.

Enquire Now

Send Enquiry

Fill in the form and our team will get back to you shortly.

Your information is secure and will never be shared.

Send Message