Knowledge Hub

What Is a CDMO vs. a CRO? Understanding Their Roles in Drug Development

In drug development, two key partners are CDMOs and CROs. While their roles may overlap, CDMOs focus on drug formulation and manufacturing, while CROs specialize in research and clinical trial management. Understanding their differences is essential for navigating the drug development process.

Aug 01, 2025

The Role of High Potency APIs in Oncology Drug Development: A Deep Dive

High Potency Active Pharmaceutical Ingredients (HPAPIs) are vital in oncology, allowing the production of targeted cancer therapies. These compounds deliver effective treatment at low doses, making them essential for minimizing adverse effects while maximizing therapeutic impact.

Jul 30, 2025

Quality Control and Compliance in Sterile Injectables Manufacturing

Sterile injectables manufacturing is critical in delivering safe and effective parenteral drugs, especially as the demand for these products rises. Ensuring quality control and compliance is paramount, as these factors are essential in preventing contamination and ensuring drug stability.

Jul 25, 2025

Patient Centricity: Driving Compassionate Innovation Across Our Services

At Piramal Pharma Solutions, our mission is to help our clients with their quest to reduce the burden of disease for patients worldwide. Every day, we commit ourselves to doing well and doing good, ensuring that patients are the primary beneficiaries of our efforts.

Jul 18, 2025

The Role of Antibody-Drug Conjugates in Drug Development

Antibody-drug conjugates (ADCs) represent a significant advancement in drug development, combining the targeting ability of antibodies with the cytotoxic potential of chemotherapy. These innovative therapies deliver potent drugs directly to cancer cells, minimizing damage to healthy tissues.

Jul 17, 2025

Project Risk Management And Strategies For Mitigation

In the CDMO industry, 100% of projects encounter unforeseen challenges (risks), which can lead to increased costs, delays in meeting milestones, or changes in the scope of activity. Hence, risk management needs to be seen as a beacon that steers the course correction of projects. As a guiding light, risk management needs to be addressed and embraced throughout the life cycle of a project.

Why Are Proposals So Important?

Proposals are a critical part of a business because they are the starting point in the business’s evolution from concept to reality. Without knowing how to prepare and write proposals, the business will never be able to get off the ground successfully. While this is true for many industries, it is particularly relevant for a contract development and manufacturing organization (CDMO) serving the biopharma market. A successful CDMO begins with the ability to deliver a winning proposal.

Six Considerations For Success When Sourcing Your Cmc Programming

80% of NMEs in clinical developments are outsourced by small pharma companies every year out of the 13,500+ preclinical/clinical programs in 2020/21 in the pharmaceutical industry. This leads to an ever growing need to find, nurture and partner with the right contract development and manufacturing organization (CDMO). With a 9 to 12-month window to file an IND and similar aggressive timelines for other phases of clinical programs, that’s a lot to get done in a very short time!

CUSTOMER CENTRICITY: ASCERTAINING CUSTOMER NEEDS DURING CHANGING TIMES

The focus on customers and their needs is central to the success of any organization. Delivering a delightful customer experience is not only expected, it’s essential for any business that hopes to progress.

Operational Excellence: Delivering Value To Customers, Patients & Shareholders

Operational Excellence (OE) is one of the key elements of organizational leadership and organizational intelligence. It focuses on delivering maximum value to customers and stakeholders. For a Contract Development and Manufacturing Organization (CDMO) operating in the pharmaceutical industry, the focal point of Operational Excellence essentially is serving patients and customers efficiently in aspects of Safety, Quality, Delivery and Cost.

SUPPLY CHAIN MANAGEMENT : SUSTAINABILITY INITIATIVES FOR CDMOs

Sustainability is a crucial element of today’s Supply Chain Management (SCM). When designing supply chain strategies, it is essential to keep in mind responsible business practices and the commitment to society for a cleaner, safer environment.

BUILDING A CULTURE OF SAFETY AND SAFETY PSYCHOLOGY WITHIN AN ORGANIZATION

Most of you are probably aware of the well-documented case of The Piper Alpha oil platform disaster of 1988, where absence of adequate maintenance and risk assessment led to the loss of 167 lives. Another major industrial accident, the catastrophi...

PARADIGM SHIFT: REMOTE AUDITS DURING THE COVID PANDEMIC

Traditionally, most pharmaceutical companies have preferred to conduct on-site audits of their vendor partners. Seeing the partner’s facility in person and meeting the people who will be handling your product has be...

How to develop a successful regulatory partnership with a CDMO

A CDMO plays a critical role in developing and finalizing the CMC section of your regulatory filing. An experienced and technically sound regulatory team at the CDMO is a valuable partner in ensuring a swift and seamless product approval by variou...

What does a pharmaceutical integrated services program entail? Key attributes to look for in an integrated services provider.

As drug development gets ever more competitive, complex and costly, innovator and generic pharma companies are increasingly choosing contract development and manufacturing organizations (CDMOs) to streamlin...

Investigative Report Writing

According to a report by the FDA (FY2010), the third most common reason for a 483 (violation) was because of inadequate content of investigations or not completing an investigation in a timely manner. One of the most common mistakes made by the write...

Our Facility Expanding With The Market

According to recent trends in the market, the global contract pharmaceutical manufacturing industry is increasing at an average annual rate of 7.5% and is predicted to reach $79.24 billion in revenue by the year 2019. The market research firm, Vision...

Maximizing Efficiency for Our Clients

A goal of any pharmaceutical manufacturer is the pursuit of the most efficient equipment available. This equipment can increase output, reduce downtime, cut costs, and increase overall productivity while also adhering to strict cGMP requirements. The...

Why We Give

In Atlanta, Georgia, the Boys & Girls Club decided to do a Christmas experiment. 83% of the children that attend the B&G Club are low-income with some of the families not even being able to afford a Christmas tree. The children were asked what one th...

The QP in the EU

If you are a US-based company manufacturing in the US and you export your drug products in the EU, either by yourself or through a partner, you need to know EU requirements and you will face inspections based on those EU requirements.

Why It's Never Too Early to Start Considering Clinical Supplies as Part of Your Development Program

All too often the planning process for clinical supplies begins after the clinical program is set in stone and the clock is ticking. It is not uncommon to have less than 30 days from first discussions to having a requirement for supplies to be at cli...

Technical Writing in the Pharmaceutical Industry

Technical writing is not a new idea. Any type of communication written for and about industry and business with a focus on products and/or services is technical writing. Almost everyone within a company has written a form of technical document – from...

Drug Delivery Methods and Therapies for Cancer Treatment

Cancer is a widely known disease involving abnormal and uncontrolled cell proliferation resulting in solid tumor development or blood cancer conditions. Therefore, when it comes to fighting cancer, the aim is to kill the cancerous cells and/or inhibi...

PMP: Exposure to Global Project Management Methodology

At Piramal Pharma Solutions customer satisfaction is of utmost importance and we strive to meet our customers’ needs in every way we can. Our main goal is to deliver quality products within scope while still keeping budgets and timelines under contro...