Drug Product Development

Drug Product Development

We specialize in drug development of complex molecules, including new chemical entities, value-added medicines, and both generic and generic plus products. Our offerings include out-licensing, supply chain solutions, specialized analysis, custom developments, and formulation services. We have a refined drug product development process, ensuring timely delivery within budgetary constraints.

Formulation Development

Adopting a multidisciplinary approach, our pharmaceutical formulation and development process integrate advanced analytical techniques, manufacturing technologies, and principles of Quality by Design (QbD) and Quality Risk Management (QRM) at every stage of the drug product development.

Highly Potent Drug Products

The HPAPI Laboratory is equipped to safely manage High Potency Active Pharmaceutical Ingredients (HPAPI) with an Occupational Exposure Limit (OEL) not lower than 0.5 μg/m³.

Analytical Services

Our state-of-the-art laboratories offer extensive analytical services to meet clients’ specific needs. We follow strict quality procedures, GMP requirements, and ICH Guidelines, essential in the drug product development process.

Clinical Development

We provide clinical development for New Chemical Entities (NCEs), value-based medicines, and generics. We help clients navigate the complex landscape of drug development,  proposing the optimal plan for success.

Regulatory Services

Our experts handle regulatory activities to achieve approved dossiers. We provide support in submission processes and documentation management throughout the drug development process, ensuring compliance with latest international regulations.

Our Approach

We offer tailor-made drug development services, from out-licensing to custom developments and formulation services. Our streamlined drug product development process ensures smooth progress from start to finish, keeping each project on schedule and within budget. Whether you’re looking for a co-development model, prefer licensing and royalty agreements, or seek a straightforward fee-for-service arrangement, we have the flexibility to accommodate your requirements.

Quality by Design

QbD is integral to every drug product development process we undertake. Applying QbD ensures consistent development of high-quality pharmaceutical products that exceed industry benchmarks, while complying with regulatory standards.

U.S. FDA- Compliant Drug Development

Since 2022, we comply with U.S. FDA regulations for drug development services. Our team manages also the development of new product applications, including ANDA and 505(b)(2), specifically for the U.S. market.

Our Services

We specialise in the development of New Chemical Entities (NCE), Value Added Medicines (VAMs) and generics.  Our experienced team of over 60 scientists drives successful outcomes in the drug development process.

Formulation Development

  • API characterization
  • Preformulation
  • Formulation development
  • Analytical method development
  • Process development
  • Technology transfer
  • IP Search (Intellectual property)

Analytical Services

  • Method development and validation
  • Chemical compatibility
  • Forced degradation
  • Dissolution (USP I, II and III)
  • Chemical analysis of APIs
  • Finished product controls
  • ICH stability, photostability and in-use stability

Scientific and Clinical Development

  • Clinical strategy
  • Study design and sample size calculation
  • BCS Biowaivers
  • Dissolution data analysis
  • Clinical trial project management
  • Nonclinical and clinical overviews
  • Scientific advice meetings

Regulatory Services

  • Regulatory and registration strategy
  • Scientific report writing
  • Compilation and publishing of data in eCTD format
  • Liaising with regulatory authorities
  • Registration services and support
  • Risk assessment reports

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