Client Introduction
- Hyderabad, Telangana based
- Incorporated in 2022,
- A chief global provider of Active Pharmaceutical Ingredients (APIs) and inter mediate manufacturer,
- Dedicated to distributing high-quality, innovative solutions for a healthier future,
- Operates USFDA and EU GMP-certified facilities specializing in anti-retroviral (ARV) and non-ARV medications.
- Building long-term partnerships with leading pharmaceutical companies in over 80 countries,
- Determined by a shared vision of improving global healthcare access and affordability.
In a landmark move to consolidate its market leadership, our client recently completed the high-stakes acquisition of another entity’s expansive Indian API business.
Regulatory Compliance Challenges faced
Their merger was a great achievement in scale, but it brought an extraordinary volume of regulatory risks.
| S.N. | Challenges | Description |
|---|---|---|
| 1 | Documents to be updated | The agreements, licenses, consents and various permits had to be updated to reflect the new merger. There were multiple locations and departments to be taken care of. |
| 2 | Operational & Labour Risks | Since labour is a concurrent subject, they face varying state-specific rules for minimum wages, working hours, and social security across different factories. |
| 3 | Data Integrity Gaps in newly merged organization |
|
| 4 | Environmental & Safety Challenges |
|
How Lawrbit GCMS solved these challenges
Lawrbit GCMS acts as the “digital backbone,” specifically designed and configured to handle large volumes of multiple factory-level data and standardize multi-site compliance management. There are few benefits of implementing Lawrbit’s GCMS, such as:
-
Centralized “Single Source of Truth”: With multiple factories in different states (e.g., Vizag vs. Hyderabad), compliance documents are often scattered in local site folders. Lawrbit GCMS provides a User Specific, multi-location enabled Dashboard, which also acts like a repository of documents/compliance evidences, with details mapping of multiple locations and departments to the respective stakeholder.
It also substitutes manual entries with automated records featuring automatic audit trails that capture every tiny detail for each action. - Environmental & Safety (EHS) Tracking: API manufacturing involves hazardous chemicals. Missing a quarterly ongoing compliance will send alerts to the entire ownership matrix. Further, visual Compliance Heatmaps show them which factory (Unit A vs. Unit B) is “Red” (high risk) due to pending renewals or overdue internal audits.
- Real-Time Alerts: Automatically tracks and integrate regulatory updates, notifying the functions about changes to ensure the merged entity remains compliant nationally. The regular scheduling of regulatory webinars, both internal and external, gives our clients an edge to always stay ahead the curve and prepare themselves for any industry specific changes.
- Flexible Architecture: The Lawrbit GCMS allows utmost flexibility to change the ownership matrix, edit the uploaded documents, add new users and change the Company profile and configuration with all logs created for easy audit.
In summary, an API business in India today operates under a “compliance-first” regime where the cost of a single oversight can be hefty.
For a multi-factory enterprise, manual tracking is no longer a feasible policy. The transition from volatile firefighting to proactive digital domination is the only way to sustain growth in a highly analyzed industry.
Lawrbit GCMS provides the operational visibility required to protect the company’s licenses, reputation, and bottom line across diverse geographical sites and manages related documents too.
Locations
8
Departments
15
Acts
86
Compliance
1850
Locations
- 🏢 Manufacturing Units
- 🔬 R&D Labs
- 🌐 SEZ Location
- 💼 Corporate Office
Departments
- ⚖️ Compliance & Secretarial
- 📜 Legal
- 💰 Finance
- 📊 Accounts-Taxation
- 👥 HR
- 📣 Marketing
- 🏢 Admin & Facilities
- ⚙️ Engineering
- 🌱 Environment
- 🛡️ Safety
- 👁️ Security & Vigilance
- 💻 IT
- 🪪 License
- ✨ Quality
- 📦 Warehouse
Users
- 🛠️ Makers 84
- ✅ Checkers 46
- 🔍 Reviewers 19
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