At Sterling Healthcare 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 ICH norms
- Dossier development in compliance with ICH CTD 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
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: Sterling group has experience of regulatory processes ISO certification and cGMP aspects.
- Financially sound to support the investments required.
- Layout to match the regulatory requirements as per US-FDA, UK-MHRA, 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.
Sterling Healthcare 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 Indian and multinational companies.
- Sophisticated cGMP 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.