CMC Support

Partner-level support for your CMC reporting needs

The support your company receives from Exelead doesn’t end with manufacturing and logistics. Our team works with you to develop your documentation for the CMC (chemistry manufacturing and controls) aspects of your regulatory submission.

 

Because our team is involved in the development scale up and manufacturing of our client’s processes, we are uniquely positioned to provide personal support and CMC document generation for our clients seeking approvals from the FDA and other regulatory bodies. Our team will help generate the proper CMC data and reports and join you for the meetings, teleconferences and site inspections with regulatory agencies.

 

As a starting point, clients working with Exelead generally receive standard CMC support documentation as part of our processes, including: manufacturing process summaries, component/process flow diagrams, and equipment/process validation summaries, master batch production records, and batch specific production records.

 

We are also happy to customize our reports in any way needed to comply with the standards of regulatory bodies in the countries where your trial or sales will be generated. We have experience with pharmaceutical regulations in a number of global regions including: North America, South America, Europe, Middle East and North Africa.

 

We actively support clients distributing products in: United States of America, Canada, Mexico, Argentina, Brazil, Columbia, Venezuela, Belarus, France, Germany, United Kingdom, Kuwait, Bahrain, Oman, Saudi Arabia, Qatar, Iraq, Jordan, Libya, Morocco, Lebanon, and United Arab Emirates.