Pharmaceutical Development

Pharmaceutical Technology
- Dry blending
- Wet granulation: 1) Fluid Bed technologies; 2) High shear mixer
- Extrusion granulation
- Tablet compression
- Capsule filling
- Oral solutions/suspensions and emulsions
- Semi-solid (cream, gel, ointment)
- Sterile liquid injectable
- Freeze-dried forms
- Nasal sprays
- Ophthalmics mono-dose or multi-dose preservative free
- Formulations from immediate release to extended release/slow release formulations
- Drug delivery formulations
Pre-formulation Development Services
Initial Risk Assessment:
- Regulatory strategy and patent review.
- Sourcing constraints
- Quality by Design approach: preliminary design of Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA) to consider (drug substance and drug product)
- API physical-chemical characterization (Particle Size Distribution, Enantiomeric forms, Polymorphism)
- Excipients and packaging materials selection
- Compatibility studies between API and excipients
- Reverse engineering studies from existing products (where applicable)
- Toxicology assessment and substance categorization
Formulation Development Services
- Formulation optimization and manufacturing of small batches for toxicological animal studies
- Prototype generation and Design of Experiments (DoE)
- Design of qualitative-quantitative formula. Definition of QTPP and CQA
Investigational Medicinal Product (IMP)
- Manufacturing, labelling, packaging and release of IMP and placebo
- Support on the preparation of the Investigational Medicinal Product Dossier (IMPD)
- Support on the design of clinical BE studies.
Industrialization Services
- Manufacturing Process Development and Critical Process Parameters (CPP) Definition
- Scientific and technical support on scale-up and engineering batches prior to full scale validation/registration batches to Third Manufacturers
- eCTD services like authoring, validating and e-publishing submissions in eCTD formats.
- Tech Transfer Out
Analytical Development Services
- Analytical Method Development and Validation for Drug Substance and Drug Product
- Analytical Method Development and Validation for Impurities, Related Substances and Preservatives
- Extractable & Leachable studies
- Forced degradation studies
- Comparative In Vitro Dissolution Tests
- In vitro – In vivo studies
- Pre-stability and ICH stability studies
- Analytical Method Development and Validation
- Validation of microbiological methods
- In vitro Release testing (IVRT)
- ICH for zone II, IVa , IVb, US&EU, semi permeable products. Stability Chambers housing.
- Consulting Services (eg. GAP, Training, Audit)
Regulatory Services
- Advice on regulatory registration strategy
- Advice on CMC issues related development stages, manufacturing, quality control release testing,
- Specifications and stability of the product
- Nitrosamines risk assessment and ICH Q3D elemental impurities
- Toxicology assessment of NCE, PDE
- Advice on clinical issues related to manufacturing of IMP
- Support on the preparation of the Common Technical Dossier (CTD)
- Support on the preparation of the Investigational Medicinal Product Dossier (IMPD)
- Preparation of answers to Regulatory Bodies
HPAPI Products
A dedicated area for non-GMP studies including High Potent APIs (HPAPI) suitable for:
- Manufacturing of batches for toxicological studies in animal models
- Formulation trials at lab scale
- Design of experiments
A new dedicated area will be able to work under GMP conditions Safebridge 3A HPAPIs and suitable for:
- Manufacturing of Investigational Medicinal Product Phase I/II
- Comparability studies
- GMP DoEs in lab scale
Small Scale GMP Manufacture
A new GMP Pilot Plant will be fully operational in 2022 and suitable for:
- Manufacturing of small commercial batches of Speciality Drugs
- Manufacturing of Investigational Medicinal Products for Phase II/IIl (HiPo and Non HiPo)
Consumer Care Development

Initiation of the Development
- Customer Orientation, Key Concepts, Positioning
- Product Categorization, Market Analysis
Formulation Development
- Regulatory Requirements, Compliance, QTTP
- Safety, Technical, Regulatory data documentation for raw materials
- Formulation Development, Literature Research, Laboratory scale prototypes,
- ICH Stability, Pre-Safety Toxicological Assessment, CQA
- Packaging Development
- Analytical Methods Development
- Microbiological Methods Development
- Development Report
Product Development
- Definition of QTPP and CQA, Finalization of Formula
- Process Optimization
- GMP scale-up Production, Filling, ICH Stability, Compatibility
- Clinical Studies, Safety Studies, Efficacy Studies
- Technical File, PIF initiation
Planning & Production
- Support on Industrial Validation Batch Production, Filling
- Industrial Validation Batch ICH Stability
- Analytical Method Validation
- Microbiological Methods Validation
Product Release to Market
- Technical File Support | PIF completion
- Transfer Out activities (if applicable)