5207 Militia Hill Road, STE 100

Plymouth Meeting, PA 19462

United States

info@pharmulalabs.com

Phone: 610-828-2757

Fax: 610-828-2107


Regulatory


Quality of Our Services

Stability Studies

Analytical Method Development and Validations


Formulation Development 


Preformulation studies 
API and excipient comparison and approval tests, physical & chemical characterization
Oral tablet and capsules
Oral tablets, capsules of immediate release and controlled release; bioenhanced formulations for poor water soluble drugs
Oral solution and suspension 
Oral solution and suspension for prescription or OTC, and pediatric or geriatric use
Parenteral products
Liquid and lyophilized product
Topical drug delivery 



At Pharmula Laboratories, we conduct formulation studies with attention to how the formulation will be manufactured in the future and ensure regulatory compliance of the ingredients (GRAS).  We identify potential stability problems at beginning of our formulation work. Our formulation compositions are reported with clear and precise compounding/formulation process instructions. Our formulation development work also includes a selection of container/closure systems for your product, solving problems such as the compatibility of your drug with container/closure systems, compatibility with dosing apparatus, temperature stability of a product under the conditions of pharmaceutical processing, and other relevant concerns. We work for our clients in an integrated process development and scale-up for a faster timeline and less trouble in the future. With a full range of formulation and analytical development capabilities, we can accelerate your molecule through development to market.
  • Regulatory compliance in product development
  • Preparation and/or review of the chemistry, manufacturing and controls sections of regulatory submissions
  • All experiment activities, data and reports are kept in a controlled document system and they will be ready for audit under request.
  • We promise a fast turn around time, and successful deliverables.
  • Our methods are scientifically reliable.
  • Our formulations are based on real production and market needs.
  • Our laboratories are managed according to the best laboratory practices.
  • We follow Confidentiality and Regulatory agency compliances.
  • Guaranteed customer satisfaction.

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  • Design stability study protocols
  • Conduct stability studies in our computer-monitored stability chambers
  • Analytical method development: FDA-required stability indication methods

Pharmula Laboratories is perfectly positioned to help your needs in analytical method development.  We are your source for FDA-approvable analytical methods that meet all FDA and ICH requirements.  


At Pharmula Laboratories, we provide customized method validation services according to applicable ICH/ICH/EPA/other regulatory agency guidelines.  


Method validation is a continuous process. The goal is to ensure confidence in the analytical data throughout product development.

  • Barrier/reservoir type by coating technology 

  • Temperature-controlled release of matrix
  • Taste making of multiparticules
  • Delayed release:
    • Enteric coating
    • Delayed “dump”
    • Pulse
  • Better product for bioavailability challenges 

  • Lipid based formulation, softgel technology
  • Hot melt extrusion for tablets and capsule
  • Micronized/Nano particulate technology
  • Flash/fast-dissolve
  • Sustained release
  • Combination profiles via multiparticulates and bilayer tablets

Our Specialities

Our consulting portfolio enhances our ability to help clients improve their analytical, formulation, and product development.


Our Services