Development

Shriharipharmachem can provide support for the development of Analytical Methods, Programs and Products as demonstrated by the hundreds of analytical test methods, the multiple programs, groups, labs, and range of products developed.

Methods have been developed ranging from simpler to proven validated complex state-of-the-art award winning systems.

Programs have been initiated to implement various studies and improvements and have also included setting up / remediating various research, development and quality groups and laboratories.

Product development has spanned a wide range including sterile and non-sterile, solutions, suspensions, gels, films, emulsions, tablets, capsules, implantable devices and external measuring devices. These have involved small and large / polymer molecules, including both natural and synthetic. Development experience has spanned from concept and strategy to product submission.

The following is a list of current support available:

Methods Development

Analytical method development and validation

• Design / advise / support on-site method development
• Ensure thorough and expedited method development & validation activities
• Advise / support method validation – including related analytical instrument qualification (AIQ) and computer software validation (CSV)

Program Development

Dissolution science program optimization

• Evaluate / audit instrumental systems, methods and practices
• Advise / support for general dissolution practices & strategies
• Advise / design / support an advanced dissolution program
• Advise / support specific projects (DoE, QbD, IVIVR/C, BA/BE)

Laboratory Development / Optimization

• Development Research & Development Group
• Drug Delivery & Controlled Release Program / Optimization
• Optimized Analytical Tools

Quality Control Remediation / Optimization

• Gap Analysis & Remediation Strategy / Program
• Inspection Readiness
• Coaching & Mentoring

Specialized Proficiency and Advance Technical Training

• Polymer & Materials Characterization
• Laboratory Statistics
• Laboratory & Manufacturing Investigation Training
• Methods Development & Validations Program

Product Development

• General Product Development – Design & Optimization
• Strategic Drug Delivery Product Development

Translational and Clinical Development Services

• Drug Discovery and AI-Based Screening of Compounds
• Formulation selection and development
• Formulation contract research service provider identification and negotiation
• Identifying manufacturing partner for pharmaceutical formulations
• Auditing formulation development and manufacturing service providers
• Clinical Development Strategy Designing for Drugs, NDDS, Medical Devices, Biologics, Vaccines, Ayurvedic/Herbal Products, Cell Therapy, Nanotech Therapy products
• Clinical Study document designing and review (e.g., Protocols, ICFs, CRFs, Source Templates)
• Clinical Trial Report Writing (CSR, CER), Abstracts, Manuscripts
• Clinical trial scientific and regulatory consultancy
• CRO identification and qualification
• Clinical study budget coordination and management
• GCP, GLP, GCLP Audit and CAPA management
• Training on GCP, GLP, GCLP, GDP, GMP
• End-to-end project management for phase I–IV clinical trials
• Manpower supply for clinical research (contractual/consultancy)
• Vendor identification, qualification, and management
• Designing clinical trial units (e.g., BA-BE Unit, Bioanalytical Lab) and obtaining regulatory approvals (e.g., India, ANVISA, MHRA)
• Developing Clinical Trial Sites at hospitals and healthcare centers
• Custom software development for clinical research
• Representing clients at events, conferences, and meetings
• Technical support during client sales meetings
• Support for proposal, quotation, budget, and protocol preparation
• Business development and promotion for clinical services