Chemistry and Manufacturing Controls Consulting

There are many places in the chemistry and manufacturing controls development for drug products where activities might be disrupted or not work out. One key way to avoid or mitigate these risk is to have a strong CMC consultant team on call to assist or to address any obstacles.

Pharmaceutical consultants are a commonly used resource inside the biotech industry and most manufacturers won't embark on the development of a new API or product without having the assistance of a team of pharmaceutical consultants to rely on. The team needs to know all forms of issues starting with FDA compliance through to the good manufacturing practice (GMP) guidelines.

PharmaDirections makes their consultants available with several unique benefits.

• Experts in all CMC areas are available for our pool of 150 Senior Associates
• Clients can access the CMC experts by the hour or on a retainer basis or as part of a project team
• Experts are trained in our proprietary manufacturing execution software - InstantGMP
• Strategic planning and project management are always available
• Our experts can guide a manufacture through any FDA compliance issues