Global Goals

Technology Driven

Focused on Quality and Delivery

Operations
SERVICES:

At BrightWay Pharmaceutical Manufacturing Company we offer the following range of services:

  • Contract Manufacturing of Oral Solid Dosage Forms :
    → Site variations
    → Co-development for dossier filing
    → Contract supply agreements
    → Bulk packaging and customized retail packaging

Stability Studies as per UK law

  • Dossier development in compliance with UK law guideline
  • Regulatory assistance
  • Quality Control back-up for :
    → Manufacturing (including in process controls)
    → Process validation
    → Stability testing
    → Microbiological testing
    → Formulation Product development
  • Sourcing of APIs:
    → Extensive database of molecules underdevelopment
    → Backed by generics API development
    → Professional sourcing experience
    → Backward integration to make API’s for finished dosage forms
  • Customer Service Department :
    → One window approach
    → Understanding of cross-cultural issues in communication
    → Dedicated resources to help in IPR, customized product requirements

Confidentiality and protection of Intellectual Property of clients is our top priority.

  • Customer audits of our facility and processes to ensure compliance are encouraged and supported
PARTNERING ADVANTAGE

Brand new unit matching all relevant norms of regulatory authorities.

  • Dedicated contract manufacturing operations for regulated markets.
  • Professional corporate set-up ensures efficient management of operations
  • Relevant experience: BrightWay Pharmaceutical Manufacturing Company has experience of regulatory processes ISO certification and US law aspects.
  • Financially sound to support the investments required.
  • Layout to match the regulatory requirements as per US-FDA, WHO and other international regulatory agencies.
  • Logical man and material movement to ensure unidirectional flow avoiding cress cross.
  • Flexibility in operations, design of various parameters ensures quick changeover between products.
  • Separate two lines, one for tablets and one for capsules, minimizing the risk of contamination or cross-contamination.
CAPABILITIES

BrightWay Pharmaceutical Manufacturing Company offers a wide range of manufacturing capabilities in oral solid dosage forms viz. tablets, capsules & sachets.

  • Key people in charge of operations are trained, qualified and approved by regulatory authorities.
  • Most people with experience from leading UK and multinational companies.
  • Sophisticated automated machines for various manufacturing operations.
  • Ability to enforce stringent controls on entire batch process.
  • Facility designed to maintain environmental conditions supporting high production efficiency & quick turnaround.