Biotech Consortium India Limited

Transcription

1 INVITING EXPRESSION OF INTEREST (EOI) FOR EMPANELMENT OF CERTIFICATION AGENCIES FOR UNDERTAKING GLP CERTIFICATION Biotech Consortium India Limited New Delhi

2 EMPANELMENT OF CERTIFICATION AGENCIES FOR UNDERTAKING GLP CERTIFICATION A. BACKGROUND Biotech Consortium India Limited (BCIL) is a company promoted by the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India and is set up by All India Financial Institutions including IDBI, ICICI, IFCI, UTI and IFCI Venture Capital Funds Limited. It was incorporated as a public limited company in 1990 with government in advisory role and development banks as major funding agencies, with the mandate of facilitating commercialization of biotechnologies. BCIL is actively involved in activities such as technology transfer, project consultancy, project management, information dissemination and human resource development. To assist Research Institutes engaged in development of drugs to take forward their products through the regulatory process, it is proposed to empanel individuals/companies engaged in GLP certification and assisting in conduct and certification of preclinical studies. BCIL invites Expression of Interest (EOI) from reputed national/international certification consultants/companies based in India with sound technical and commercial credentials for their empanelment for the services mentioned in section B. B. SCOPE OF WORK The scope of work shall fall under the following two categories- 1. GLP certification of existing Animal House facilities for both invitro and invivo toxicity. 2. GLP certification for preclinical regulatory safety studies The scope of services would include but not limited to: i. Assessment of existing animal house facility and performing a GAP ii. iii. iv. analysis Providing effective solutions for addressing the gaps identified, if any Documentation work required for GLP Conduct a pre-assessment audit to ensure that the Research Institute meets the desired certification requirements v. Assistance during final certification audit to ensure that the GLP certificate vi. vii. viii. is accorded Training of the Staff Writing Standard Operating Procedures (SOPs) for conducting preclinical studies, maintain GLP compliance etc. Assist in obtaining GLP certification of preclinical regulatory studies conducted by the Research Institutes. 2

3 C. ELIGIBILITY CRITERIA: The individual/company should have minimum five years experience in assisting Institutes in obtaining GLP certifications for existing animal house facilities and/or preclinical regulatory studies conducted by the Institute. D. INSTRUCTIONS TO TENDERERS 1. Interested parties are requested to fill up all the forms enclosed and submit the bid with all the necessary documents. 2. Documents to be submitted a. Form A General information b. Form B GLP certifications for existing animal house facilities and preclinical regulatory studies conducted by the Institute, directly facilitated in last 5 years c. CVs of key staffs d. Major certificates and accreditations e. Attach audited balance sheets for last three financial year 3. The EOI in the prescribed form, duly signed shall be submitted in a sealed cover super scribed EOI for empanelment as Certification Agency shall be submitted to the following address on or before 25 th January 2017, 05:30 pm (extended to 28 th Feb 2017). Managing Director Biotech Consortium India Limited V Floor, Anuvrat Bhawan 210, Deen Dayal Upadhay Marg New Delhi Empanelment will be for a period of three years. (can be extended upto five years). 5. BCIL may, at its discretion, extend this deadline for submission of EOI by amending the Bid Documents or any other reasons, in which case all rights and obligations of the BCIL and bidders previously subject to the deadline will thereafter be subject to the deadline as extended. 6. In the event of the date specified for bid receipt and opening being declared as a closed holiday for BCIL, the due date for submission of EOI and opening of EOI will be the following working day at the specified times as given above. 7. BCIL will not be held responsible for the postal delay, if any, in the delivery of the bidding document or the non-receipt of the same. EOI sent by /fax will not be accepted. 8. Evaluation: The evaluation will be carried out by a Technical Committee of BCIL based on the eligibility criterion. Such decision by BCIL shall bear no liability consequently and the decision of the Committee shall be final. 3

4 9. BCIL rights: a. BCIL reserves the right to accept or reject any bid in whole or in part, or to reject the EOI without assigning any reasons. BCIL may decide not to continue with the empanelment and cancel the notice inviting EOI either full or in part at its discretion. b. BCIL reserves the right to club or split the items of works, change the qualifying criteria at their discretion and to reject or cancel the Invitation for EOI without assigning any reason thereof. c. BCIL reserves the rights to discontinue the services for next phase of GLP certification for preclinical studies if not happy with the outcomes Managing Director 4

5 FORM A GENERAL INFORMATION 1. Name of the Individual/Company:. 2. Legal Status of the Individual/Company: Registered Address, Telephone, Tele-fax: Contact Person, Designation and address including id: 5. Annual turnover of the individual/company for last three financial years (audited certificate should be attached): i. from GLP certification of Animal House Facilities : ii. from Preclinical Regulatory Studies: iii. or both: 6. Number of years of experience in GLP certification of : i. Animal House Facilities : ii. Preclinical Regulatory Studies: 7. Details of certificates and accreditations (documents to be attached): Notes: (i) (ii) Attach an attested photocopy of Certificate of Registration. The Consultants /Companies may apply for empanelment for one or both of the following Servicesa. GLP certification of Animal House Facility b. GLP certification of Preclinical Regulatory Studies Sign & seal of the tenderer 5

6 FORM B DETAILS OF SUCCESSFUL GLP CERTIFICATION CONDUCTED IN INDIA IN LAST FIVE YEARS FOR A. Animal House B. Preclinical Regulatory Studies 6