Every medicine. Every batch. Every step accountable.

Our regulatory function is the centre of the business rather than a support role. It decides which products we pursue, and it carries them from assessment through to approval and beyond.

Recognised authorities

What we do

• Product registration dossier compilation and submission to the Department of Drug Administration
• Marketing authorisation verification at product level
• Certificate of pharmaceutical product, free sale certificate and legalisation coordination
• Import licensing and quota applications
• Brand name registration and labelling compliance for the Nepali market
• Renewals, variations and post-approval lifecycle management

Regulatory contact: Regulatory Affairs Desk · regulatory@cytolix.com

Any medicine can cause an unexpected reaction. Reporting these is how the safety profile of a product is understood and how patients are protected, and we treat it as an obligation to our partners as much as to patients.

Reporting an adverse event

If you are a healthcare professional, patient or caregiver and have observed an adverse event or suspected reaction involving a product distributed by Cytolix Labs, please report it to us. Reports can be made regardless of whether you are certain the medicine was responsible.

What to include

• Product name and batch number, if available
• A description of the event and when it began
• The age and sex of the person affected — no name is required
• Your contact details, so we can follow up if needed

What happens next

Reports are recorded, assessed and forwarded to the marketing authorisation holder and to the Department of Drug Administration in accordance with Nepali requirements. We will acknowledge your report and may contact you for further detail.

Reporting an adverse event to us does not replace seeking medical advice. If you or someone in your care is unwell, contact a healthcare professional.

Quality management system

Quality Management System

Our quality system governs how products are received, stored, handled and released, and how deviations are recorded and corrected. It rests on documented procedures rather than individual judgement, so that performance does not depend on who is on duty.

• Standard operating procedures covering receipt, storage, picking, dispatch and returns
• Defined responsibilities and trained personnel, with training records maintained
• Deviation, complaint and corrective-action recording
• Periodic self-inspection against our own procedures
• Change control for any modification affecting product handling

The integrity of a medicine can be lost after it leaves the factory. Distribution practice is what prevents that, and it is the part of our operation a manufacturing partner has most reason to examine.

• Storage conditions: product-specific controlled ranges with monitoring records available for partner review
• Cold chain: equipment qualification and documented temperature-excursion handling
• Transport: product-appropriate packaging and documented controls for temperature-sensitive medicines
• Traceability: batch-level records maintained from import through to dispensing point
• Recall: documented procedure executable at short notice, with defined responsibilities
• Falsified medicines: goods received only through the authorised supply chain and reconciled against documentation

Licences & credentials

Our licences

Published so that partners, institutions and regulators can verify our standing without asking.

Code of ethical conduct

How we conduct business

Our partners carry compliance obligations in their own jurisdictions that extend to the conduct of their distributors. We operate to standards designed to hold under that scrutiny.

• Promotion is evidence-based and consistent with the approved product information. We do not promote unapproved uses.
• We do not offer or accept improper payments or inducements of any kind, to anyone, in connection with our business.
• Interactions with healthcare professionals are for legitimate scientific or educational purposes and are documented.
• We do not promote prescription medicines to the general public.
• Concerns about conduct can be raised at compliance@cytolix.com and will be handled confidentially.