At Vera Pharmaceuticals, we offer a comprehensive suite of services designed to support our pharma and biotech customers at every stage of the drug development lifecycle. With over 50 years of experience in the global healthcare industry, we are committed to delivering innovative solutions, exceptional quality, and unparalleled customer service.
Generics Division
Product Development
We specialize in the development of high-quality generic medications, ensuring that they meet stringent regulatory standards and address diverse therapeutic needs. Our product development services include:
- Formulation Development: Creating bioequivalent formulations of branded drugs.
- Analytical Development: Comprehensive analytical method development and validation.
- Regulatory Support: Preparing and submitting regulatory documentation to global health authorities.
Manufacturing
Our state-of-the-art manufacturing facilities are equipped to produce a wide range of generic medications, ensuring consistent quality and supply. Our manufacturing services include:
- Batch Production: Scalable production processes to meet market demands.
- Quality Assurance: Rigorous quality control measures to ensure product safety and efficacy.
- Packaging and Distribution: Efficient packaging solutions and global distribution networks.
Originators Division
Research and Development
We partner with pharma and biotech companies to bring innovative therapies from concept to market. Our R&D services include:
- Preclinical Studies: Conducting in vitro and in vivo studies to evaluate safety and efficacy.
- Clinical Trials: Managing clinical trial design, execution, and data analysis.
- Regulatory Submissions: Providing comprehensive regulatory support for new drug applications.
Custom Synthesis
We offer custom chemical synthesis services for advanced pharmaceuticals requiring complex chemical processes. Our expertise includes:
- Process Development: Developing and optimizing synthetic routes for active pharmaceutical ingredients (APIs).
- Scale-Up Production: Transitioning from laboratory-scale synthesis to commercial-scale manufacturing.
- Quality Control: Ensuring the highest standards of purity and consistency.
Specialized Services
Lifecycle Management
We assist our clients in maximizing the value of their pharmaceutical products through effective lifecycle management strategies. Our services include:
- Product Line Extensions: Developing new formulations, dosage forms, and combination products.
- Market Access: Navigating market entry strategies and reimbursement pathways.
- Intellectual Property: Providing support for patent strategy and protection.
Regulatory Affairs
Our regulatory affairs team offers expert guidance to ensure compliance with global regulatory requirements. Our services include:
- Regulatory Strategy: Developing tailored regulatory strategies for different markets.
- Dossier Preparation: Compiling and submitting regulatory dossiers for product approvals.
- Post-Approval Support: Managing regulatory obligations and variations throughout the product lifecycle.
Quality Assurance
Quality is at the core of everything we do at Vera Pharmaceuticals. Our quality assurance services include:
- GMP Compliance: Ensuring compliance with Good Manufacturing Practices (GMP) across all operations.
- Auditing: Conducting internal and external audits to maintain the highest quality standards.
- Training: Providing comprehensive training programs on quality management systems and regulatory requirements.
Why Choose Vera Pharmaceuticals?
- Experience: Over 50 years of industry expertise.
- Innovation: Cutting-edge technologies and novel approaches to drug development and manufacturing.
- Quality: Commitment to the highest standards of quality and regulatory compliance.
- Customer Focus: Tailored solutions to meet the unique needs of our clients.
At Vera Pharmaceuticals, we are dedicated to advancing global healthcare through innovative and reliable pharmaceutical services. Partner with us to bring your therapeutic innovations to life and improve patient outcomes worldwide.
Contact us today to learn more about how we can support your drug development and manufacturing needs.