Unrivalled regulatory experience with a dedicated commitment to quality
Our company operates to the highest international standards of quality. Our teams are committed to delivering a quality service at each stage of a process from development through to commercial manufacturing, delivering high-quality products at all times.
Quality by Design techniques and the effective use of formal risk management processes are used to define and steer a compliant product strategy that controls and mitigates risk.
Our facilities are regularly inspected by national and international regulatory authorities as well as our clients.
Quality Assurance
- We operate both classical and lifecycle validation approaches following FDA guidelines.
- Our focus is on Expediting product filings through the registration batch approach.
- Services supported by Product quality risk assessments.
- Strict procedures support Document control both in issuance and through robust archival policies.
Our policies support our clients' active involvement to ensure that no risk occurs in the process of bringing new drugs to market.
Regulatory Affairs
Our highly experienced team can offer complete API regulatory support from initial submission to market authorization:
- We have extensive experience in the preparation and submission of:
- DMFs for EU/US and several other countries and continents.
- EP-Certificate of Suitability (CEP).
- Our team also helps our clients in post-approval support activities, including update and variation changes of DMFs & CEPs.
- Our flexible approach in addressing our clients' needs has resulted in many successes and is focused on continuing this track record.
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“Dishman Group” is not a separate legal entity but nomenclature used in generality for Dishman Carbogen Amcis Ltd, the flagship Company, and its Indian and foreign subsidiaries, joint ventures and associate companies across the globe. All these entities are individual and separate by the law.
