FAQ

Who is Tergus?

Tergus is a CRO (Contract Research Organization) providing complete solution for your topical product development needs. With several years of existence, the industry leaders at Tergus work towards providing a spectrum of development services. We start with formulation development of the new molecule, perform analytical R&D following the regulatory compliances, achieving skin penetration studies, pre-clinical batch creation of Phase I through III clinical supply, conducting in vitro release testing and providing consulting for variety of projects.

Is Tergus an FDA compliant site?

Tergus is registered with the FDA as a contract research organization and complies with relevant national and international regulations and guidelines of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).

Who can come to Tergus for Services?

Anyone having an idea to develop a topical product, can reach out to us at any stage of the product development life cycle. We provide services at all stages of the drug delivery either on stand-alone basis or as an end-to-end solution.

Why should you come to Tergus?

We have industry leaders from varied domains with several years of experience. Employees at Tergus not only excel in their field of study but gradually improve on their skillset to help you develop a product from scratch. Using years of developmental experience, combined with understanding the best path forward for clinical and regulatory affairs, we are the single destination to reach topical product development goals.

We have a patented molecule, can Tergus help in designing the Proof of Concept?

Yes, we can definitely help you by screening formulas, looking into efficacy models, to a suitable a dosage form.

We are a start-up/virtual pharma with a novel idea (patent registered), how can Tergus help us?

We help you bring the idea to reality by working on it from formulation to GMP manufacturing.

We are a medium-size pharma exploring into topicals, how can Tergus help us?

Mid-size sized pharmaceutical companies with unique pipelines may often be limited by budgetary constraints or infrastructure. Tergus comes to the rescue by providing exceptional services with risk mitigation strategies and reduced capital investments.

We are a large-size pharma wanting to outsource topical product development, how can Tergus help us?

Large pharma companies trust Tergus because of our quality and delivery standards. Topical formulation development is a niche technology, requiring specialized experience that is not always available in large labs. Therefore, large pharma companies outsource to Tergus to manage the complete development program.

We have our filed our product with FDA and it now required additional support data, how can Tergus help?

We can support you at every step by not only providing the services needed, but also with suggestions that would help you from a regulatory stand-point.

We have a formulation that is instable, can Tergus help us develop a stable formulation?

Definitely, with our formulation expertise and strategic approach we can help you develop physically and chemically robust products.

We have a formulation that is showing low release rates of active, can Tergus help improve the release profiles?

Absolutely, it’s all about the formulation play (excipients, process, concentration, etc.) to modify the release rate kinetics of the active substance. With our inhouse expertise and high throughput screening we can optimize the formulation to have a better release profile.

We have a formulation ready at hand and need to manufacture scale-up for GLP/GMP studies, can Tergus help us scale-up?

Tergus can support GMP/GLP compliant batch manufacturing ranging from 3kg to 150kg.

We would like to develop a generic product which is highly time-sensitive, can Tergus support us?

Tergus is known for its low turn-around-time and support for Paragraph 4 and Paragraph 3 filings.

Is Tergus capable of developing 505(B)(2)?

We have the inhouse expertise in developing different dosage forms, from pre-formulation to manufacturing with full CMC support.

Can Tergus deal with high-potent molecules?

We have specialized high potent labs and equipment to handle potent molecules.

What are the safety measures taken at Tergus?

The safety committee at Tergus ensures that the facility is compliant with NAOISH, OSHA regulations.

How is the product data stored at Tergus?

Measures are taken to maintain confidentiality of data and ,also, we archive 10 years of data.

Can Tergus conduct Tech transfer to a CMO?

We support tech transfer activities with all necessary dossiers and ensure that all phases of transfer undergo smooth commercialization.

We have a developed analytical method and locked formula, can Tergus build up on it for scale-up?

We can validate the analytical methods and tweak them if necessary, before and after scale-up manufacturing.

Can Tergus support reverse engineering?

Tergus partners with 3rd parties to support reverse engineering.

Does Tergus provide consulting in topical formulation?

Tergus boasts with advanced scientific knowledge to provide consultation at all stages of product development.

Does Tergus procure materials that are required for development?

We work with vendors (choice of clients) to procure materials at all different stages of product development.

We need a scale-up batch within the next 4 weeks, can Tergus support us?

Assuming that the analytical test methods are suitable and the raw materials do not have any long lead times, Tergus can qualify the methods, scale up the manufacturing process within four weeks. We call this, at Tergus, Fast Track Chemical Supply Program.

Does Tergus have any experience working with large biomolecules for topicals?

Tergus provides services for topical formulation development of large molecules. We formulate biologics with aqueous buffers and appropriate pH ranges to avoid potential aggregation. Topical formulations with large molecules are prepared with attentive care. Tergus ensures the manufacturing process avoids use of heat, shear and harsh solvents. To deliver conformationally stable therapeutic agents, stabilizers can be added to the formulation to prevent denaturation or oxidation of cysteine residues. Appropriate preservatives and storage conditions are also maintained to prevent molecule or formulation degradation. Tergus has experience with analytical method development and analysis of large molecules. We have a range of HPLC columns, such as size exclusion and ion exchange column in addition to reverse phase columns typically used for small molecules. Tergus also works closely with several 3rd party vendors for analytical outsourcing if required.