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Comprehensive Contract
Formulation R&D


Nayas | Services | Formulations

Nayas integrates innovative approaches and cutting-edge research through comprehensive contract development services specializing 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 Conceptualization to Commercialization 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.

DOSAGE FORM EXPERTISE

Orals

Oral Solids

Oral Liquids

Parenteral

Injectables

Ophthalmics

Implants


Topicals

Creams

Ointments

Gels


Nasals

Nasal Sprays

Nasal Drops


Transdermal

Patches

Others

Sterile Infusions

ODF



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

  • HPLCs with photodiode array detectors
  • HPLCs with UV detectors
  • UV Spectrometer
  • FT-IR (A Fourier Transform Infrared) spectrometer
  • NMR (Nuclear Magnetic Resonance)
  • Potentiometer
  • Dissolution apparatus with Auto sampler


REGULATORY AND DOSSIER SUPPORT

  • Dossier Compilation and Preparation Support
  • Regulatory Filing and Submission Support
  • Regulatory Affairs Support
  • CTD Documentation
  • Dossiers Meeting Various Global Requirements
  • Dossiers submission Support Documentation for Global markets.
  • Deficiency responses and related regulatory documentation.
  • Technical IP Review Support.

QUALITY

  • Site Master Plan & Quality Manual
  • Equipment/ Instrument Qualification
  • Calibration & Preventative Maintenance Programs
  • Document Management System
  • AMCs for Equipment/ Instrument & Employee Training Programs
  • Tech Transfer Dossiers for Site Transfer


  Fee For Service

  Out-Licensing

  Co-Development

  Contract Testing

BUSINESS MODELS

Partner with us to take your products faster into the market. with the highest Quality Standards at an affordable price.