Services

Expertise and tailor made solutions in the following fields:

Pharmaceutical CMC

Food Supplements

Medical Devices

Competence and experience by providing you the right support for:

External Contract Manufacturing Coordination

Project Management

Interim Management

Details of our services:

Regulatory Area, Quality & Production (Technical Professional Consulting):

We provide support (interim management, ad-hoc coordination, leading of interdisciplinary teams etc.) and project management as well as technical training (on-site or webinars) in different technical areas (Production and Drug Product Development) and according to your needs for complex projects with a clear goal in mind: solving problems and helping to find innovative and sustainable solutions. An example is the assistance and troubleshooting for pharmaceutical formulations (new or existing) and the resolution of production problems in pharmaceutical/food supplements products (solid, liquid and semisolid dosage forms).

We take care of drafting, authoring and revisions of pharmaceutical documentation for Rx and OTC pharmaceutical products (CTD Part 3. : Quality) Modules 1, 2, 3, 4, 5. We also provide support for Quality Expert Modules / Statements (CTD Part 2.3) and Scientific Reports, as well as support for the drafting of Pharmaceutical Patents.

We develop for our customers production methods, Master batch records, Standard Operating Procedures (SOPs), Safety Data Sheets, internal manuals and many other quality-related documents. We supervise the preparation of stability plans and their management in-house or by third parties.

If necessary, we use an extensive network of national and international collaborations.

We handle technical translations of pharmaceutical, nutritional, or technical dossiers in general.

Outsourcing:

We identify the ideal CMO/CDMO production partners according to your needs, managing relationships, timing, costs and production and development projects on your behalf. This will allow you to dedicate your resources to the strategical activities, allowing to have a full control of the processes and results.

Management Consulting:

We carry out a detailed analysis of your internal processes and help you to follow operational excellence objectives and KPI definition.

We accompany you in the formulation of the appropriate strategy and ensure a measurement of the results obtained.

We provide coaching for new managers and executives.

We structure your ideas in the context of Project Management (Task Force or lead of internal and external projects).

Strategic Area / Marketing / Commercial:

We manage on your behalf your commercial and technical contracts according to your needs.

We draw up business plans, SWOTs, Strategy Sets, we help you to define the strategic objectives in a coherent way.

We help you to analyze the reduction of business costs according to your needs.

We advise you in the preparation of corporate promotional brochures.

We monitor, evaluate and, if necessary, suggest any changes deemed necessary on company websites in order to ensure consistency in social communication.

Human Resources Management:

Through our experts we can search for you the distinctive resources you need and support you at all stages of their introduction.

We evaluate and advise you in the optimization of your company organization, help you train your employees and provide them with the necessary coaching.

We organize the appropriate and targeted training through specific courses in both technical and management areas.

We help you to plan a talent management and human resources development plan for new job descriptions, also following job rotations.

Supply Chain Management:

We analyze the value chain for you, identifying possible points of improvement.

We provide you with commercial and technical support for the purchase of Materials and Raw Materials (APIs, excipients, packaging) from third parties, managing the negotiation practices always with a win-win perspective.

We research and qualify your manufacturers / retailers of raw materials (APIs, excipients, materials and certifications).

The Phases of Counseling:

Phase 0:
Initial Analysis

Phase 1:
Listening

Phase 2:
Coaching

Phase 3:
Closing report

Phase zero

We start on the requests and preliminary (non-confidential) information provided by the Client and quickly interpret the situation and its needs, estimating costs, time and effort and summarizing the collaboration project in a detailed proposal.

Phase one

The first phase of the consultancy is completely aimed at listening and gathering information, always guaranteeing maximum confidentiality and intervening in a targeted manner to solve any problems and provide the best solutions.

Often the client needs support especially in this first phase, where it is necessary to identify in detail the processes and flows.

It is our care to provide our point of view and mentoring in this context, thanks to our long experience in the life sciences.

In this phase it is essential to be very pragmatic, to generate plans that are both detailed and flexible and to estimate costs as reliably and quickly as possible.

Phase two

The second phase of our relationship generally requires accompaniment at the client’s premises or remotely, depending on the needs.

In this phase we offer the contribution of our experienced and tested freelancers, chosen within our portfolio in an optimal way and according to their specific distinctive skills, to accompany the Client Company and be present responsibly in every phase or important milestone of the project.

The client’s growth and learning are fundamental for us and imply an involvement and identification with his needs and expectations.

Phase three

The third part of the consultancy is the one that ends with a detailed report, which lists all the points touched upon, the needs expressed by the client in the initial phase and the solutions proposed, with our position and practical suggestions for the next steps.

Consultancy is conducted in a personalized and punctual manner according to the Client Company’s needs (hourly, daily, weekly, monthly, quarterly, half-yearly, annual).

At the basis of our value proposition (we help companies in the Life Science sector to achieve results through tailor-made solutions thanks to the skills of our experts), active listening, problem solving, continuous support and the definition and respect of deadlines are fundamental roles. Our consultancy can take the form of ad hoc needs, repeated contracts for limited periods or long-term strategic partnerships.

«The tailored solution for your Life Sciences projects»

Tailored B2B support thanks to our expertise and experience in the pharmaceutical and nutritional areas.

Examples of Our Customers' Objectives

To solve an important problem (both urgent and on deadline)

To deal with strategic and operational problems that need to be solved without spending very large amounts of money with large international consultancy firms