# Your quality emergency, handled by an expert who is already effective. An injunction to lift, an inspection to prepare, a critical role left vacant. Bio15Pharma finds the right expert within days; Sinfony gives them the method, the training paths and the tools to act from the moment they arrive. Sinfony is your single contracting party. Bio15Pharma acts as our delivery partner in the field. ## The interim manager arrives. Then loses three months. You have tried this before. Someone capable showed up — and took a full quarter to become useful. The reason is mechanical: dropped into an organization in crisis, they have no method specific to your site, no tooling, no training material. So they rebuild what they did elsewhere. Sometimes that works. Often it adds another layer to a quality system that is already too thick. Nobody sells the profile _and_ what makes them effective. That is precisely what this partnership does. 100% of staff must be trained for the activities they perform. The requirement does not pause because a role is vacant. Source: 21 CFR 211.25 (eCFR) 5 to 15% of revenue is lost to the cost of poor quality — often because the work is not fully mastered at the workstation. Sinfony sector estimate ## Who answers when you call. Two life sciences specialists whose trades are strictly complementary. ![Sinfony](/assets/logo/Sinfony/SVG/sinfony_colors.svg) The consulting, the training and the tools 25 years alongside life sciences industries and sovereignty sectors. Sinfony makes organizational performance independent of key individuals: industrial performance consulting, digital regulatory training and AI-powered tools. - 35 consultants across France, Belgium and Luxembourg - Over 100,000 people trained, 20,000 auditable certificates - Over 200 regulatory and technical modules - Sanofi, Takeda, Merck, GSK, Novo Nordisk, Unither, Cenexi _Unleash Your Skills._ [Learn more](/en/about/) ![Bio15Pharma](/assets/img/urgence-qualite/logo-bio15pharma.png) The experts and the field A quality management and GxP compliance consultancy, founded in 2021 in Rouen by Nadjim Mhoma after thirteen years turning around critical situations in big pharma. Bio15Pharma places interim managers in key roles and handles injunction crises. - Around 3,000 independent experts available at 24 hours' notice - 21 ANSM, FDA and ANVISA injunctions lifted - Member of LEEM - France, Belgium, India; projects in Ireland, the United States and Korea The patient at the center of every process. [bio15pharma.com](https://bio15pharma.com) ### Separately, neither one solves your problem. An interim management firm alone finds you the right person. But they arrive with no method fitted to your site, no training material and no tooling — and take a quarter to have any effect. A consulting firm alone brings you the method. But it hits the wall you already know: nobody internally has the time or the mandate to apply it, and the plan stays on the shelf. The two together deliver the person _and_ what makes them immediately effective. It is the only combination that treats the cause of the delay, not just the vacant role. And none of it complicates things for you: you sign with Sinfony. One contract, one accountable party. ## Five situations that will not wait. ### An injunction to lift ANSM, FDA, ANVISA. Production, certification, batch release and commercialization all have to resume. ### An inspection to prepare The date is set and nobody can say with certainty where the system actually stands. ### Remediation to run The observations have landed, the action plan is due, and no team has the bandwidth. ### A critical role vacant Qualified Person, quality director, QC manager: the operation is blocked. ### An audit at short notice Supplier or raw material, including outside France, with a qualified auditor to find fast. ### Your situation is not listed? Describe it in one sentence. We call you back within 24 hours to tell you whether we can help — or not. [Get a callback](#request) ## Four steps, three months. Bio15Pharma finds. Sinfony trains. Bio15Pharma qualifies. Sinfony transforms. 1. 1 ### Find Profile identified and placed within 5 days, drawn from a network of around 3,000 independent experts available at 24 hours' notice. Bio15Pharma 2. 2 ### Train A digital path targeted on the actual gap: over 200 regulatory and technical modules, with auditable certificates. Sinfony 3. 3 ### Qualify On-site qualification and certification at the workstation, with the teams who will hold the system together after we leave. Bio15Pharma 4. 4 ### Transform Documentation simplification, deviation management, and method transfer so autonomy outlasts the assignment. Sinfony A joint assessment — field review and pre-study — is presented between day 7 and day 10. Pricing follows, on quotation. ## Two trades, no grey area. The boundary is clear, and it is contractual. ### Bio15Pharma — the field - Sourcing and placement of the interim manager - On-site qualification and certification - Crisis management for ANSM, FDA and ANVISA injunctions - Supplier and raw material audits, internationally - Cleanroom decontamination, compliant with Annex 1 A quality management and GxP compliance consultancy, member of LEEM. France, Belgium and India, with projects in Ireland, the United States and Korea. ### Sinfony — the digital and the method - Regulatory and technical training paths - Auditable certificates and audit-ready traceability - Pre-study, quantified analysis, findings review - Documentation simplification and deviation management - Method transfer to your internal teams 25 years in life sciences industries. France, Belgium, Luxembourg. [See consulting](/en/consulting/) · [See the Academy](/en/academy/) ### One contract, one accountable party You sign with Sinfony, who carries the commitment end to end and steers the assignment. Bio15Pharma acts as our delivery partner. No double invoicing, no second point of contact, and no passing of responsibility between suppliers. ~3,000 independent experts available at 24 hours' notice 21 injunctions lifted with Bio15Pharma +100,000 people trained by Sinfony 20,000 auditable certificates issued 25 years of sector expertise Together, Sinfony and Bio15Pharma have worked with Sanofi, GSK, Novartis, Takeda, Merck, Guerbet, Novo Nordisk, Aguettant, Unither and Cenexi. > “You are the consultants with the nerve to actually make things move.” Novo Nordisk > “What we have just seen is a world-first innovation.” Canadian inspection, Nov. 2022 ## Describe your situation in one sentence. No specification document to fill in, no budget to declare. We need to understand what is blocking you, and how to reach you. - **Callback within 24 business hours.** From a Sinfony consultant, not a switchboard. - **A straight answer.** If we are not the right fit, we tell you on that call. - **Profile placed within 5 days** if we go ahead, with the assessment presented between day 7 and day 10. Your data is processed within the European Union and is never sold to third parties. [Privacy policy](/en/privacy-policy/). This form requires JavaScript. Write to us directly at [contact@sinfony.eu](mailto:contact@sinfony.eu) describing your situation: we will call you back within 24 business hours. ## What you are about to ask us. Who do I sign with? + With Sinfony, and Sinfony alone. The contract is issued by the Sinfony entity in the country where the work takes place. Bio15Pharma acts as our delivery partner, under our responsibility. How fast can an expert be in post? + We call you back within 24 business hours to qualify the situation. The profile is then identified and placed within 5 days. The joint assessment is presented between day 7 and day 10. Do you guarantee an injunction will be lifted? + No — and be wary of anyone who promises you that: the decision belongs to the authority. We commit to the mobilization, the method and the quality of the case you will put in front of them. Bio15Pharma has contributed to lifting 21 injunctions to date. Do you work outside France? + Yes. Sinfony operates in France, Belgium and Luxembourg; Bio15Pharma in France, Belgium and India, with projects in Ireland, the United States and Korea. The training component is digital, so it deploys anywhere. What does it cost? + On quotation, issued after the joint assessment — the scope of a quality emergency cannot be priced off a catalog. What we do commit to on the very first call is the timeline. ## Describe your situation in one sentence. We call you back within 24 business hours to tell you whether we can help — or not.