CMC consulting services driven to service your needs.
Through a diverse team of highly qualified and experienced Project Managers, Technical Leaders, CMC Regulatory Specialists and Quality Assurance/GMP-Compliance Trainers, Exova SL Pharma provides consulting services covering all aspects and stages of Chemistry, Manufacturing and Control (CMC) product development in both the pharmaceutical and biotechnology industry.
Our CMC consulting services include:
- Development and implementation of strategies and detailed plans for:
- Early stage drug discovery and pre-clinical development packages for both small and large molecules
- Pre-IND CMC development and implementation
- Formulation Development, Analytical Development and Microbiological Development, Process Development, Clinical Manufacture, Technology Transfer, Scale-up and Manufacturing Validation. Special expertise in parenterals and sterile products.
- CMC Documentation Package (IND, NDA, ANDA); preparation and submission to the FDA
- Assist pharma/drug companies who have received 483’s and/or warning letters from the FDA in identifying and resolving CMC deficiencies
- Project management services offering to assume full responsibility on behalf of our clients to develop a fully coordinated comprehensive project plan, coordinate and manage the execution of the plan and complete it in a timely manner
- Provide training in various aspects of GMP/QA-Compliance during all phases of product development, commercial manufacturing and quality control.
1300 First State Blvd, Suite C,
Wilmington, DE 19804
Contact: Waheed Sheikh - President
Tel: +1 302-636-0202
Fax: +1 302-636-0204