CRAMS
LEVERAGING Technology for CRAMS Leadership
Embracing cutting-edge technology solutions is pivotal for our Contract Research and Manufacturing Services (CRAMS) business to achieve unparalleled growth. This approach empowers us to utilize technology effectively, securing our leading position in the market.
Wide gamut services across the development chain:
Chemistry
- Hit to Lead
- Lead Optimization’s
Pre-clinical
- Synthesis and Purification
- Ref. Standard and Impurities
Phase 1- Phase 3
- Process Optimization’s through Process Understanding
- cGMP Production
Commercial
- Process Validation
- Manufacturing
- Life-Cycle Management
Designing, Developing, and Optimizing Chemical Processes:
- Route Scouting
- Tech Transfer Services
- Chemical Process Engineering
- Salt and Polymorph Screening
- Process Development and Optimization through process understanding
- Identification and Characterisation of Impurities
- Chemical Process Safety
- Kilo Lab Manufacturing and Scaleup
Analytical Development and Research for Processes:
Our analytical laboratory facility undergoes audits by the US-FDA and holds approval, ensuring compliance with 21CFR Part 11 systems.
- Method development
- Method validation and transfer
- Polymorph screening
- Forced degradation studies
- Impurity isolation and characterization
- Stability studies
- Elemental impurities profiling
- Genotoxic assessment
Strong Foundation for Intellectual IP Protection
Our analytical laboratory facility has undergone audits by the US-FDA and obtained approval, ensuring adherence to 21CFR Part 11 compliance systems.
- Mandatory CDA for all employees to ensure confidentiality
- Well-established data systems for the protection of information at all levels
- Customer drives all program needs with no internal programs
- IP assigned to clients at the beginning of relationships
Being a prominent provider of specialized API services, VDPL Sciences delivers a comprehensive range of contract development and manufacturing solutions worldwide, driven by its cutting-edge Research & Development (R&D) Centre.
Our expertise covers the complete spectrum of a novel chemical entity’s value chain, spanning from early discovery to late-stage commercialization. This includes analytical services, impurity synthesis, and regulatory support. Committed to client satisfaction and retention, we excel in large-scale manufacturing and possess unparalleled proficiency in process development for early-phase drug development compounds.
Our exceptional quality standards and global accreditations in GMP manufacturing have garnered the trust of pharmaceutical firms across North America, Europe, and Japan. As we broaden our presence, we’re delving into niche technologies to distinguish ourselves as the preferred partner for clients seeking innovation and excellence in API services.