FIRST STAGE - Request for proposal - RFP

Bioequivalence studies for Dapaglifizum, 10 mg film-coated tablets

Background

Tarchomińskie Zakłady Farmaceutyczne “Polfa” Spółka Akcyjna (Polfa Tarchomin S.A.) is one of the oldest and most experienced pharmaceutical companies in the Central Europe. Our history goes back to 1823. Nowadays there are four pillars of our generic business: Anti-infectives (oral and injectable forms), Alimentary Tract & Metabolism products, Central Nervous System drugs and Dermatologicals.

Currently, Polfa Tarchomin S. A. develops Dapagliflozinum 5 mg and 10 mg film-coated tablets generic product, and we would like to invite you to prepare a proposal for bioequivalence studies as described below.

The project is co-finansed from the state budget under a grant awarded by the Medical Research Agency.

A. Project and product information

Tested product- Dapagliflozinum, 10 mg film-coated tablets

Reference- Froxiga, 10 mg film-coated tablets

Registration-

Assumed study design - Bioequivalence

IMPD availability - 10.2024

Currently, Polfa is developing three strengths 5 mg and 10 mg of Dapagliflozinum, film-coated tablets. However, due to the composition proportionality and the PK linearity, Polfa plan to use a biowaiver for lower power.

We plan Randomized, Open-label, Single Dose, Two-treatment, Two-period, Cross-over, Pivotal Bioequivalence Study Comparing Dapagliflozinum (tested product) and Froxiga 10 mg film-coated tablets (reference product) under fast condition.

SmPC of Froxiga, 10 mg coated tablets is available on website:

https://www.ema.europa.eu/en/documents/product-information/forxiga-epar-product-information_en.pdf

This is just for information purposes.  

We are interested in full service for one single dose bioequivalence study including the clinical conduct, bioanalytical part, data management, medical writing, project management, RA/EC submission etc.

Please provide at least two sample size options, i.e. assuming T/R ± 5-7,5%.

If more data on ISCV appear in the literature in the future, the sample size may change.

Proposal for bioequivalence studies

The offer should contain at least:

1. information about the proposed studies: study design, number of subjects, number of sample per subject per period, total PK samples, analytical method
2. proposal of timelines assuming the above IMPD availability, duration of the study from start of documentation preparation until draft study report
3. costs calculations for:
   1. clinical part (preparation of the study design according to EU requirements and essential documentation for RA/EC submission, submission to RA/EC including fees, clinical conduct including all medical and safety laboratory assessments and PK sampling and remuneration to subjects, data management and integrated study report (ICH-E3), QA during the study);
   2. analytical part (method development and validation, if applicable, PK samples analysis including ISR, reports);
   3. PK and statistical part (pharmacokinetic and statistical analysis and report);
   4. other costs needed (for example monitoring, PK and documents transport, analytical reference standards, overheads etc.). Please list these costs if needed. 

Additional information expected from the bidder

We kindly ask you to provide the information listed in the attached excel file named ‘BIO offering TOC’. Please provide the information either in the offering document or in the Excel document as it is most convenient for you.

 B. Conditions for participation

1. Present registry documents (National Court Register EDG or equivalent, Certificate of Fiscal Residence).
2. Confirmation of an appropriate experience in realization of similar services. Supplier should have at least 3 years’ experience, knowledge and abilities, should be demonstrated by realization of at least ten (10) studies. Documents should include information about contractor, study specification and delivery date.
3. Clinical site capacity of admission of all volunteers in one round / one period.
4. Preparation the full scope of services specified in the RFI/TOC:
   1. Study planning;
   2. Preparation of study documentation, submission of applications to the Bioethics Committee/relevant authorities, obtaining appropriate opinions and consents;
   3. Clinical part: staff training, volunteer recruitment, administration of products, collection of samples, subjects examination;
   4. Bioanalytical part: method development and validation, test sample analysis;
   5. Pharmacokinetic and statistical part - preparation of study results;
   6. Preparation of the final study report;
   7. Study insurance (in cooperation with the Sponsor);
   8. Preparation and archiving of study documentation.
5. Compliance with European formal requirements by the center (appropriate certificates: GCP, GLP, Certificate of Laboratory Accreditation, ISO certification, the results of own audits / inscpetions ) including full compliance with the Regulation 536/14, CTIS submission service (for studies conducted in Europe).
6. Confirmation of compliance with the above mentioned requirements. 
7. Conducting the study according to the determined by the Sponsor timelines: 30.11.2025 – Study Report.
8. An unblemished CRO reputation– verification i.e. via official EMA inspection documents including concerns about the reliability of the company (if available), publicly available sources (i.e. web sites).

C. Terms of the offer submission 

1. Deadline for submitting Offer is 05-04-2024 at 23:00 CET. The deadline for Answers submission may change, all Suppliers will be informed by e-mail from the Procurement system. 
2. Any Supplier may submit only one offer. 
3. Partial offers are not allowed. 
4. The offer with the required Attachments should be submitted in the Logintrade Procurement system (https://polfa-tarchomin.logintrade.net/). In order to submit an Offer, the electronic form must be completed and saved. The completed Attachments should be uploaded to the system.
5. Failure to complete the Attachments in accordance with the Contracting Party's guidelines may exclude the Supplier from the procedure.
6. In addition, the Supplier should present terms of maintenance services and may also prepare an offer in his own preferable format and upload it into the system. 
7. Supplier's Offer should be comprehensive in Polish or English, in electronic form. 
8. The offer should include at least the following information: supplier name and address, bid inquiry number, price, delivery date (time required for delivery), date of payment. 
9. The tenderer, before the deadline for submitting bids, has the right to:
   1. withdraw the offer by written notification by e-mail indicated for the submission of tenders, 
   2. change the offer – notification of the changes must be submitted by the same rules as the submitted offer, appropriately marked with the note "CHANGING THE OFFER". 
10. Offer validity: 90 days from the deadline for submitting offers.
11. The tenderer shall bear all possible costs related to the preparation and submission of the offer. The Contracting Party does not provide reimbursement of the costs of participation in the procedure.

D. Additional information about participation in the tender

1. The procurement procedure will be conducted in two stages.

• The first stage RFP - Request for proposal.
• The second Stage RFQ - Request for quotation - after verification of the received documentation in the RFP.

1. Documents should be placed in the Logintrade Procurement system in the Attachments section (https://polfa-tarchomin.logintrade.net/).
2. Before proceeding with the procedure, it is recommended to read the operating manual of the purchasing system available at https://polfa-tarchomin.logintrade.net/.
3. The dates of commencement and completion as well as the configuration of each stage of the procedure will be presented in the Procurement System and may be changed about which all interested Contractors will be immediately notified by e-mail via the system.
4. Technical support during the procedure. During the procedure, the contractor may use the technical assistance of the Logintrade Procurement platform (https://polfa-tarchomin.logintrade.net/)

E. General provisions  

1. The submission of an application for registration in the procedure or an offer is tantamount to accepting all terms of the procedure without reservations.
2. The Contracting party reserves the right to cancel the procedure without giving any reason.
3. The Suppliers are not entitled to submit any claims to the Contracting Party in connection with the inquiry and the proceedings conducted under the project, including costs and damages, in particular in the event of cancellation of the procedure by the Contracting Party or selection of another Supplier.
4. Withdrawal by the Contracting Party from concluding the contract in the event of notifying the Supplier about the selection of its offer, it may not be the basis for claims for the costs of participation in the procedure.
5. In the course of evaluating the submitted applications, the Contracting Party may demand explanations from the bidders regarding the content of the submitted documents.
6. If the application does not contain all the required elements, the Contracting Authority may, in justified cases, call the Supplier to supplement it.
7. The Contracting Party reserves the right to record sound during technical meetings with Bidders during the tender procedure. Sending the offer will be treated as giving consent to record the meetings.

F. Cooperation and communication 

1. All questions should be submitted via the Procurement Platform, the Message tab of the proceeding.
2. All responses will be provided to Suppliers via the Procurement Platform, the Message tab of the procedure in question.
3. The persons authorized to contact the bidders on Monday-Friday between 07.00-15.00    Please attach a signed or annotated - confidentiality agreement ( draft attached)