EXPRESSION OF INTEREST
1. REQUIREMENT OF CONSULTANT FOR DOSSIER PREPARATION
We are a Bangalore based CPSE (Government of India Enterprise) engaged in the manufacturing & marketing of Pharmaceutical formulations to domestic and overseas markets. Our products are registered and exported to various African countries, Latin America, Russia, Malaysia, Thailand, Sri Lanka etc. Our manufacturing sitesare approved by PIC/s Malaysia, Zimbabwe and Uganda etc. We are now focusing on EU GMP certification and further business expansion in other countries and registering more products in the existing countries.
In this regard we are seeking a reputed pharmaceutical product regulatory consultants /experts agencies with relevant experience in preparing dossiers in CTD format as per the country specific guidelines.
SCOPE OF CONSULTANCY FOR DOSSIER PREPARATION
- Preparation of dossier for registration/re-registration of new formulations/existing formulations as per the specified guidelines of the respective countries in CTD format for the existing countries/new countries with in the stipulated time committed with party.
- Necessary support of relevant documents will be extended from KAPL team.
- Preparation/Review and submission of queries relevant to the submitted dossiers till the registration is completed.
- To complete the registration process within time lines.
- Scrutiny of DMFs provided by the vendors as per the guidelines of EDQM, PIC/s, MHRS or any other relevant guidelines as required from time to time.
- Preparation/review of protocols/reports of product development, process validation, cleaning validation, stability as per the standard protocols/country specific guidelines.
- Preparation/review and submission of variation/amendment applications.
- Responses related to medical queries or product complaints related to ADRs.
- Assisting for any other specific requirement related to product registration on case to case other than mentioned above.
- A copy of all the documents submitted to the regulatory authority/agency shall be sent to the designated authorized person of KAPL.
- To interact with the regulatory authority and organize for GMP audits.
- Periodic training shall be imparted to the concerned officers with respect to the recent and evolving trends in regulatory requirements.
- The progress should be updated to the concerned authority from time to time through a monthly report and meeting.
- Charges shall be quoted as a lumpsum on monthly basis inclusive of all expensed and excluding the statutory taxes.
- Applicable TDS will be deducted.
- Payment will be made within 10 days after approval of the bill by the designated authority.
- Duration will be for the period of 12 months from the agreement.