Product development is the key to the Pharma business and its success is a quality product development. We at NUVO help you achieve the best development partner for yourformulation and API. With so many years of experience in the Industry, we can assist with right contract research organization (CRO) partner selection for the development based on the market entry, type of product and formulation, regulatory approvals and knowledgebase of the partner. Our CRO partners have state of the ART product development facility for formulations and API.
We cater to global product development services for formulation and API – US FDA, EU health authorities, MHRA, Indian market, LATUM, GCC, SA, Rest of the world markets
Following are the brief list of services for product development, we as a team can take up:
- Patent status evaluation
- Literature search
- Non infringing strategy Development
- Quality by design (QbD) based formulation Development
- Prototype Formulation Development
- Studies based on Design of experiments (DOE)
- Risk assessment strategies and consideration
- Potent molecule Development
- Development of Paragraph I, Paragraph II, Paragraph III and Paragraph IV
- Product development to supports NDA/ANDA, 505b(1) and 505b(2)
- Pre-formulation studies
- Deformulation (Reverse Engineering)
- Development from Lab scale to pilot and pivotal batches can be executed.
- Process Validation
- Life Cycle Extension/ Brand Extension
- Solubilization /Bio availability Enhancement
- Lyophilization
- Packaging Development
- Process Optimization
- Documentation in CTD Formats
- Technology Transfer at CMO Site
- Dossier Development – diverse dosage forms for regulated markets like USA, EU, Australia, Turkey etc.
Dosage Form Development:
- Tablets : Immediate-release, Sustained-release, Prolonged / Delayed-release, conventional Film-coated and Uncoated Tablets.
- Capsules : with Powder, Granule filling
- Pellets : Into tablets or Capsule filled
- Powders : Powder in a bottle
- Liquids : Solutions, Suspensions, Emulsions
- Semi-solids : Creams, Ointment
- Parenteral : Injectable, LVP
All the necessary machine and equipment’s of various capacities are available for performing the different scale of product development form bench, lab scale, kg scale, pilot to pivotal batches for the above mentioned formulation. To list few Compression machine, sifters, blenders, granulators, Fluid bed processing for granulation, coating and drying, coating pans, Capsule filing machine and many.
