Comprehensive Contract Formulation R&D

Nayas integrates innovative approaches and cutting-edge research through comprehensive contract development services specialising in developing complex molecules, new chemical entities (NCE), Abbreviated New Drug Applications (ANDA), 505(b)(2), First to File Generics, Generics and more.

Nayas equipped with state-of-the-art facilities, team and innovation, takes-up the complete responsibility of Formulation right from Conceptualisation to Commercialisation with highest quality standards. As part of this service offering, Nayas performs activities like Pre-Formulation, Formulation Development, Analytical Method Development and Validations, Stability Studies, Regulatory Support and Dossier Compilation Support.

Formulation Service Offerings

Generics

Complex Generics

Novel Technologies

PRE FORMULATION

Solid State Characterizations
Solubility and Stability Studies
Salt Form Selection
Excipient Compatibility Studies
Particle Size and Morphology

FORMULATION DEVELOPMENT

Our scientists use Quality-By-Design (QbD) tools at all stages of formulation development. Design of experiments (DOE) along with risk assessment strategies allows us to design our experimental plan. Our development approach allows us to meet our delivery timelines and helps us in providing with cost-effective drug delivery solutions.

Literature Search and Technical Patent Review
Marketed Product Reverse Engineering Studies
Drug-Excipient Compatibility Studies
Formulation Development and Optimization Studies
Process Development and Optimization Studies
Scale-Up and Technology Transfer
Exhibit Batches Manufacturing Support
Packaging Development Studies
Product Development Reports

FACILITIES

Direct Tablet Compression
Fluid Bed Processing (Granulation, Drying, Coating)
High Shear Granulation
Dry Granulation (Roller Compaction, Slugging)
Automated Capsule Filling (Powder, Granules, Pellets)
Low Humidity/Moisture Requirements
Taste-Masking, High Potency Compound Handling
and more...

ANALYTICAL METHOD DEVELOPMENT AND VALIDATIONS

Analytical development (AD) includes reverse engineering, method development, method validations, routine analysis and stability studies and supports our formulation development activities. The AD teams are integrated with preformulation, product development and quality assurance teams to ensure effective and accelerated product development. Our experience in developing methods for highly complex and unstable drug products compliments our formulation capabilities.

Analytical Method Development: Assay, Content Uniformity, Related Substances, Dissolution, Water Content etc.
Analytical Method Validation
Forced Degradation Studies
Method Transfers to Manufacturing site
Informal (R&D) and Formal (submission) Stability studies, Support Analysis
Specifications design based on Stability trend data
API & Excipients physico chemical characterization | Physical and Chemical Testing
Dissolution
Bioavailability & Bioequivalence Testing
Impurity Profiling

FACILITIES