Drug products are meant to treat diseases. Persons who receive medications often have the systems “out-of-tune” and are more vulnerable towards physiological challenges. It is therefore ultimately important that the medications given to patients are effective and safe.

Active pharmaceutical ingredients (APIs) constitute the most important part of the drug products. Despite advancement in electronics and robotics technology, chemical synthesis/manufacturing remains an art that requires non-automated handling in various degrees. The manufacturing process that is not in control is often of safety and quality concerns. Concepts of parameter/process criticality have been introduced and applied to guide engineering controls while regulations establish structured industrial expectations to assure that controls are consistent, appropriate and effective.

API manufacturers have to face many challenges. Risk severities vary greatly from business to business. A good grasp of intricacy in and interplay of chemical science and regulatory compliance is required to achieve good results. PharmAgents understands chemical science and speaks chemist’s language in the context of regulations. We believe in straight talks and we focus on problem-solving and quality sustainability.

PharmAgents can assist you in many ways to improve quality, fulfill for US FDA cGMP regulations compliance requirements and enhance chances for sustained business success.

Being further privileged with multi-lingual capability, PharmAgents offers unique opportunities for international clients. Vocabularies are symbols of cultures and cultural knowledge effectively conveys regulation concepts. This in turn can translate into higher assurance of compliance.

That is not all. PharmAgents strategizes flexible and beneficial relationships with clients, and we perform our services in a most sincere, effective and cost-saving manner.

Contact today and let us work together.