Alembic Pharmaceuticals Ltd. (APL) is an Indian multinational pharmaceutical company that is involved in the manufacture of pharmaceutical products, pharmaceutical substances, and intermediates. APL is also on pace to be a market leader in the macrolides segment of anti-infective drugs in India. Alembic has state-of-the-art R&D centers which collectively staff more than 500 scientists working on active pharmaceutical ingredients, oral solid dosage formulas, transdermal solutions, injectable substances, etc.
Alembic Research Centre is focused on novel chemistry, including new polymorphs, salts, and other processes eligible for a possible first-to-file opportunity. The fully-integrated R&D is made possible by AR&D, IP, RA, QA, technology transfer teams, and USFDA inspected pilot plants.
CLIENT BUSINESS CHALLENGES OR PROJECT REQUESTS
- Hard-to-manage amounts of paperwork every day in each department
- No reliable method of ensuring data security
- Software must be 21 CFR Part 11 compliant, as APL is subject to regular FDA and ANVISA audits
- Certain medical study participants frequently try to enroll for another study without waiting the required time between studies; such patients are at risk of adverse side effects, including death, based on possible interactions between study drugs.
- Payroll expenses are higher than necessary due to staffing for many manual activities that can be performed by software
- We are running this project using agile methodology
- We developed ERP software with biometric thumb verification; software never allows patients to enroll in subsequent study until “rest days” following previous studies have expired
- We studied 21 CFR Part 11 compliance and developed 21 CFR part 11 compliant solution which transfers all department activity online; data is now secure, and all performance activities are expedited
- Our software has passed FDA and ANVISA audits
- Now working with advanced-level compliance requirements, and increasing complexity of current solution accordingly
- Replaced unnecessary staffers with more efficient, less expensive technology