Pharmaceutical and Life Sciences industry is subject to ever growing challenges and regulations. Challenges are coming from all the directions. Thus Governance and risk management is as important as innovating and manufacturing the drugs. Any delay to meet challenges is fatal and counter productive. Important challenges facing the industry include:
- Patents violation by counterfeit production.
- Increasing production of generics in low wage countries, causing loss of business and profits.
- Patents’ expiry and rapid shift towards generics and biotech’s.
- Temptation of pharmaceutical industry to look and await regulators’ action for infringement of its patents, products, markets and legal violations.
- Pharmaceutical industry under intensive scrutiny through audits, quality inspections, fines and penalties, leading to loss of reputation and business. Continuous pressure to track consumer usage, drugs’ life cycle and historical records.
- Procedures relating to clinical trials, product safety and their documentation is time consuming and costly. Increasing global competition in manufacture, prices sales, taxes, duties, sales and distribution costs big headache.
M&A activities are business threatening and demanding newer solutions and even change of business model. Any change to existing regulations causes manifold changes and remedial actions. To meet such business shaking challenges and to avoid legal complications, we at IrisLogic offer effective IT solution. Our solution is quite comprehensive and effective to take care of all the legal and business requirements on a tested IT platform.
- Have been closely working in the area since 2000, with pharmaceutical leaders at a global scale.
- Valuable experience with patent regime, its enforcement and violation.
- Rich experience with Clinical Trials, Portals, and Supply Chain Management.
- Comprehensive knowledge of Laws and Regulations prevailing in the major markets of the world.