We can help minimize the challenges of doing business in the heavily regulated pharmaceuticals industry and over-the-counter (OTC) drug market. We offer microbiological, analytical, physical and sensory capabilities, along with labeling and guidance services to help ensure that your products are acceptable to both consumers and regulatory bodies alike.
Additionally, we have access to state-of-the-art, certified laboratories that can check the purity and potency of raw materials and finished products to verify compliance with strict regulatory requirements regarding a product’s safety.
To ensure that you are able to gain global market access, we provide pharmacopeial testing to U.S. Pharmacopeial Convention, European Pharmacopoeia and Japanese Pharmacopoeia standards. Plus, all of our testing is conducted under Good Manufacturing Practices (GMP) conditions, so you can rest assured that your products will have been tested to the industry’s highest standards.
We want to be sure that we are meeting all of your needs — not just the ones that take place in a testing lab — which is why we offer quality assurance programs that evaluate your entire development life cycle. We can provide factory inspections, employee monitoring and training, guidance services and independent, accredited GMP assessments.
Our OTC and pharmaceuticals team includes regulatory affairs guides, microbiologists, chemists and human factors specialists. Their expertise enables us to find solutions for almost any consumer and clinical safety concern. From clarifying labeling and packaging instructions to reviewing product use and delivery mechanisms, we’re here to help you overcome the challenges that you are bound to face.