Chemistry, Manufacturing & Controls

Support our clients in their CMC development and manufacture of safe, effective, and consistent clinical and commercial medicines

Our Chemistry, Manufacturing and Controls (CMC) team is composed of experts from industry and FDA with experience that spans CMC development for small molecules, peptides, protein therapeutics and monoclonal antibodies, ADCs, all vaccine modalities, gene therapies, cell and tissue based therapies, oligonucleotides, and live biotherapeutic products. In addition to innovator products, we have demonstrated experience with generics, biosimilars, follow-on biologics, and combination products.  
Our experts typically begin engagement in the R&D or preclinical phase and then support all subsequent phases of clinical development leading to licensure and commercialization. We also provide technical assistance to programs with approved drugs, especially with risk and change management, and compliance.
Our experts are often engaged in expert testimony for litigation as well as due diligence support.

We have experience with US, Europe, United Kingdom, Japan, China, Canada, Australia, Brazil, and many other major health regulatory authorities.  

Our technical, quality and regulatory expertise encompasses all major areas of CMC:​

• Process Development & Manufacturing
• Analytics & Formulation Development
• Quality Compliance and Auditing
• Regulatory Strategies

Technical

• Process development
• Formulation development
• Analytical method development
• Defining a Process and Microbial Control strategy 
• Utilizing tools such as Quality-by-Design and Process Risk Assessment
• Trouble-shooting analytical methods 
• Quality investigations including CAPA
• Evaluation of stability programs
• Process Validation
• Analytical Method Validation
• Packaging and Shipping 
• Facility and Equipment Control Systems
• Computer Systems Validation
• Cleaning Validation
• Process and analytical technology transfers
• Comparability assessment strategies
• Development and manufacturing oversight (Person-in-plant function)

Quality

• Audits – material suppliers, software developers, manufacturing facilities, test laboratories, drug depots, and data integrity

• Mock PLI/PAI and commercial readiness assessments

• Remediation of 483s, Warning Letters, and Complete Response Letters

• Quality Assurance & Compliance services – staff augmentation, document review, SOP drafting

• Contract Services

  • Selection of CDMO

  • Quality Technical Agreements

  • Master Service Agreements

• cGMP training and course materials

• QMS creation or evaluation

• cGMP facility engineering design review

Regulatory

• Creation or review product development plans
• Regulatory strategy and pathways to approval
• Review (GAP) and Preparation of Regulatory Submissions (pre-IND Briefing Book, IND, IMPD, pre-BLA Briefing Book, NDA, ANDA, MAA, DMF, etc.).
• Support agency meeting preparation and debriefing
• Assist with responses to agency information requests during filing review and support or participate with clients in agency meetings
• Labelling support

Book a Consultantion with an Expert