Regulatory compliance is not a one-time activity—it requires continuous monitoring of changing regulations, licensing obligations, product lifecycle management, quality system updates, authority communications, and inspection readiness. Our Regulatory Retainership acts as your extended regulatory department, providing ongoing expert support to ensure your business remains compliant while allowing your team to focus on operations and growth.
What we deliver
- Compliance Management — Regulatory Compliance Monitoring, Licence Renewal Tracking, Post Approval Change Management, Regulatory Gap Assessment.
- Regulatory Advisory — Unlimited Email Queries, Scheduled Expert Consultations, Regulatory Interpretation, Product Classification, New Product Strategy.
- Documentation Review — Artwork & Label Review, Promotional Material Review, Technical Documentation Review, SOP Review, Specifications Review, Stability Protocol Review.
- Regulatory Operations — Licence Applications, Post Approval Changes, Portal Filing, CDSCO SUGAM, ONDLS, State Licensing Portals, Medical Device Portal.
- Audit Readiness — Inspection Preparation, Mock Audits, Observation Responses, CAPA Review, Regulatory Risk Assessment.
- Legal & Compliance Support — Show Cause Notice Review, NSQ Advisory, Regulatory Representation, Drafting Replies, Legal Documentation, Prosecution Coordination.
Our Approach
Understand Your Business
Review products, licences, manufacturing sites, markets, and regulatory obligations.
Develop a Compliance Roadmap
Identify compliance gaps, define priorities, establish regulatory calendars, and assign responsibilities.
Continuous Regulatory Support
Provide ongoing advisory, document reviews, filing support, authority interactions, and rapid resolution of regulatory issues.
Monitor, Improve & Grow
Track regulatory changes, conduct periodic compliance reviews, prepare for inspections, and support business expansion into new markets.
Who this is for
Why Businesses Choose Our Retainership
Instead of hiring:
- Regulatory Manager
- Regulatory Consultant
- Technical Writer
- Compliance Expert
- Legal Advisor
You get all expertise through a single engagement.