Pharmaceutical companies strive to comply with current good manufacturing practices (cGMPs) and applicable statutes and regulations at their manufacturing plants. Non-compliance to cGMPs may cause delays in product time-to-market, recalls of distributed products, damage to company’s reputation, and even turn out into litigation with business partners and/or investors.
We assist our clients to comply with regulations and current expectations by performing comprehensive audits, identifying risks, delivering tailored training, and developing solutions for potential compliance issues even before they arise.
Our competitive advantage is our systematic and thorough facility assessment approach based on the deep knowledge of international harmonized requirements as well as FDA inspectional compliance programs and internal procedures. Our experience focuses on the manufacture of active biopharmaceutical ingredients and sterile finished products.