Formulation Development

Built for complex formulations

Every effective therapy starts with a stable formulation, and that is where our technical expertise comes in. With over 30 years of experience in small molecules, we specialize in the development of non-sterile liquids, semi-solids, and suspensions, supporting everything from early-stage clinical development to the optimization of existing formulations.

Our formulation development services are designed specifically for the pharmaceutical industry and built around strategic partnerships, where our team acts as an extension of yours. Guided by a culture of quality and a science-driven approach, we help you to accelerate the drug development timeline and de-risk your investments.

We also offer support for pre-IND activities, providing early-stage guidance and technical insight to help lay the foundation for a successful development program.

Formulation development machinery

Pre-Formulation Studies

Our pre-formulation studies are designed to identify the physical, chemical, and biopharmaceutical properties of your API. This knowledge informs data-driven decisions that minimize risk, guide strategy, and support a stable formulation. It helps us to determine if a compound is suitable and compatible before we move to formulation design.

Our Core Capabilities

  • Solubility and Stability Evaluation: Our team performs early screening of the API’s aqueous and solvent solubility, as well as its thermal, chemical, and photostability. These studies help us to determine key formulation decisions and excipient compatibility to guarantee the stability of your drug product.
  • Molecular Stability and Excipient Compatibility: We assess and identify potential degradation pathways (hydrolysis, oxidation, polymorphic transitions) and test the compatibility of the API with potential excipients to ensure integrity throughout development and product shelf-life.
  • Dosage Form Strategy: Based on the API’s properties and the target of the drug product (including patient population, therapeutic goals, and route of administration), we guide you through the selection of appropriate dosage forms, such as oral solutions, suspensions, or semi-solids.
  • Timeline and Clinical Trial Readiness: Our pre-formulation studies align with your early-stage manufacturing goals, enabling the timely delivery of preclinical and Phase I drug products, ensuring smooth progression through regulatory milestones.
  • Manufacturing Insight: One of the key advantages of working with a small CDMO is that all activities are managed by a single, integrated team at the same site. From day one, we align formulation design with our manufacturing capabilities. It enables early coordination, minimizes scale-up challenges, and reduces the risks associated with technology transfer later in the drug development.
  • Quality by Design and Design of Experiments: We integrate QbD and DoE principles to define critical quality attributes, critical process parameters, and optimize input variables from the start, which shortens the drug development timeline.
Formulation development Laboratory at Groupe PARIMA

Formulation Development at the Core

We have built our formulation development service with flexibility and precision. It’s designed to deliver robust, scalable, and regulatory-compliant pharmaceutical drug products. By combining chemistry, process engineering, and regulatory compliance, our team brings deep industry knowledge and hands-on experience in guiding products from concept to market. Our expertise includes:

  • De Novo Development – Creation of custom-designed new formulations based on API characteristics and therapeutic intended use.
  • Deformulation – Rebuild or reverse engineering of an existing product or reference-listed products for 505(b)(2) or generic pathways.
  • Formulation Optimization – Improve the overall performance of the drug product by enhancing stability, manufacturability, or bioavailability of existing formulations.

We integrate quality by design principles to define critical quality attributes, critical material attributes, and critical process parameters from the start. Through design of experiments studies, we define the optimal design space, ensuring consistent product quality across all scales and shortening your development timeline.

Our Integrated Advantage

Working with a single-site CDMO offers a distinct advantage. Our integrated team manages all activities, from formulation development to commercial manufacturing, in the same facility. It helps us eliminate the risks associated with tech transfer and reduces delays during scale-up, enabling us to move from clinical development to patient delivery faster and more efficiently.

We assess compatibility early in the formulation development to ensure that selected materials support drug product stability, performance, and processability. It helps us to prevent formulation issues and align with regulatory requirements from the start.

  • Evaluate excipient–API compatibility to ensure chemical and physical stability.
  • Assess primary packaging compatibility to confirm that container-closure systems don’t interact negatively with the formulation.
  • Analyze material compatibility to support robust and scalable product design.

Once the formulation composition is defined, our process engineers establish and optimize the manufacturing process to ensure efficiency, scalability, and quality:

  • Identify CPPs and their relationship to product quality using risk-based QbD methods.
  • Through structured experimental plans (DoE), we optimize process parameters, including mixing speeds, homogenization, and heating profiles, as well as other unit operations.
  • Robust process design with scalability and GMP transferability in mind reduces the risk of delays during validation or scale-up.

Our in-house analytical teams support each formulation with method development and testing capabilities in:

  • Chemistry: Assay, purity, degradation, and physical-chemical characterization.
  • Microbiology: Preservative efficacy, microbial limits, and bioburden testing.
  • Functional Testing (IVRT): In-vitro release testing to evaluate the performance of semi-solid and topical formulations.

We also provide:

  • Method optimization and feasibility studies
  • Early assessments to define method parameters and ensure reproducibility.
  • Pre-validation activities.
  • Including robustness testing, intermediate precision, and sample stability assessments.

As part of our end-to-end development process, we guide the selection and integration of primary and secondary packaging components to ensure compatibility, stability, and regulatory alignment.

  • Primary packaging selection based on formulation requirements (liquids, semi-solids, suspensions).
  • Secondary packaging operations, including labeling, cartoning, and serialization.
  • All packaging activities are integrated within our facility to streamline development and reduce transfer risks & delays.

All development work is designed for seamless transition to GMP manufacturing, handled in the same facility:

  • Clinical, exhibit, and commercial batches. 
  • Engineering batch design and scale-up risk assessments.
  • Process documentation to support validation and regulatory filings.

We offer a fully compliant validation service, aligned with regulatory requirements:

  • Manufacturing process validation.
  • Cleaning and holding validation.
  • Packaging validation.
  • Serialization onboarding and validation
  • Procurement of GMP materials.
  • Product stability studies under ICH conditions.
  • Management of artwork with external partners.

Accelerate Your Regulatory Applications

We contribute with comprehensive and reliable technical data to support your regulatory submissions, including:

  • Quality-related data for 505(b)(1), 505(b)(2), and ANDA submissions. 
  • Well-documented formulation, process, and analytical development reports.
  • Validation summaries and stability data aligned with ICH guidelines.

While we don’t compile full regulatory dossiers, our contributions are designed to integrate seamlessly into your regulatory strategy, supporting faster approvals and fewer questions during review.

Pharmaceutical Formulation Department at Groupe PARIMA

Advancing APIs into Drug Products

As a pharmaceutical CDMO, we understand how critical it is to develop your API as a stable, effective, and scalable drug product. Our expertise in complex drug products and innovative pharmaceuticals allows us to partner with startups and global pharmaceutical companies to advance ideas into safe and effective treatments that meet real-world needs.

Our capabilities reflect a strong and diverse portfolio, with hands-on experience across more than 45 APIs. Our depth of expertise positions us as a trusted partner for small molecule drug products in the pharmaceutical industry. Here’s a look at some of the APIs we’re currently working with, or have successfully supported in the past:

  • Acyclovir 
  • Adapalene 
  • Alprostadil 
  • Amcinonide 
  • Atovaquone 
  • Benzocaine 
  • Benzoyl peroxide 
  • Betametasone 
  • Chlorhexidine 
  • Ciclopirox 
  • Clindamycin 
  • Clobetasol 
  • Crotamiton 
  • Desonide 
  • Desoximetasone 
  • Diflucortolone 
  • Dihydroergotamine 
  • Efinaconazole 
  • Erythromycine 
  • Fluocinolone 
  • Fluocinonide 
  • Gabapentine 
  • Gentamicin 
  • Glycopyrolate 
  • Halobetasol 
  • Hydrocortisone 
  • Lidocaine 
  • Meloxicam 
  • Metronidazole 
  • Mometasone 
  • Naproxen 
  • Nefopam 
  • Nitroglycerin 
  • Oxcarbazepine 
  • Prednisolone 
  • Prilocaine 
  • Tacrolimus 
  • Tavaborole 
  • Triamcinolone 
  • Urea