Pennsylvania Bio Pharma Company selected MakroCare for CMC Regulatory Services.

Adding on to its list of Global Top 20 and small-mid size Pharma-Biotech clients for Regulatory services, MakroCare has been awarded one more project from a Pennsylvania based Bio pharmaceutical Company that focuses on discovering and developing novel small molecule therapeutics in oncology and infectious diseases.

Under this agreement, MakroCare will be providing services in the CMC space, first assessing client’s current CTA documents for gap analysis, providing an overall assessment report followed by preparation of CMC and QOS sections of an IND to support client’s Phase I study in infectious disease (Hepatitis B)

Given our track record of meeting global quality standards and delivery excellence across client engagements, thanks to support from MC Regulatory Affairs Center of Excellence (RACoE), MakroCare is looking forward to complete the project in compliance with FDA requirements within the specified timelines and to the utmost satisfaction of our client.