pharmaworkslogo V6 w motto

We cooperate with leading Contract Research Organizations operating state of the art facilities. Having access to adequate resources and expertise to offer end to end product development to global healthcare companies.

Services offered are:

formulation

Formulation Development

Product development is our core competency. Having state of the art formulation development / Analytical development /QC lab, GMP scale up manufacturing plant and stability chambers to cater formulation needs under one roof, our work starts with literature search, patent landscaping and strategy development. Based on the formula and process optimization studies using DOE concept, final composition and manufacturing process is suggested for bio-study and scale-up. We operate a FDA approved GMP facility to manufacture scale up / Pilot BE batches to ensure process robustness & reproducibility.

formulation59

Flavour Development

We offer consulting services and project management concerning the flavour of products and flavour-influencing processes. Delivering a personalized service and tailored solutions for your technical challenges.

Profit from our broad range of experience in food and beverage technology, and our knowledge of the links between sensory analysis, instrumental analysis and flavour. According to your needs, we develop plans and define the steps, for you to reach your objectives on a efficient and result driven track to success.

flavor 14_630x420 half

Analytical Development

Our Pharma Research is fully supported by a comprehensive and state-of-the-art Analytical R&D facility to meet the ever rising demands of the global healthcare industry. Experienced scientists and advanced capabilities lead to fast and scientifically sound results.

We support development of drug substance & drug product and focused on accelerating the product development cycle.

analytical34

Clinical batch manufacturing

Our Product Development programs rapidly accelerate your product to Pilot BA / BE studies using Process Optimized Formula Composition. We are into manufacturing of GMP Scale up batches to provide a seamless approach through all phases of development and finally to commercialization.

From simplified dosage forms in the earliest clinical pilot BA / BE studies to critical registration / submission / small volume commercial batches are being manufactured by us.

clinical_batch_07

Stability studies

We employ qualified personnel to conduct stability studies of drug products and substances in compliance with various global regulatory agencies and ICH guidelines.

We operate 100 000 Litres of storage space with walk-in or reach-in stability chambers including refrigerated and freeze thaw conditions as well as photo stability and scalability, with abundant space in the facility to extend to 250 000 Litres if needed.

stabystore02

All chambers are individually monitored permanently by facility-management datarecording and alarming which complies to US FDA 21 CFR Part11 with back-up units. We provide stability testing to support your regulatory submissions, and ensure accurate evaluation of quality, strength, purity, potency and identity of the products.

stabystore06

Synthesis of organic compounds

Our team promises timely delivery of technically challenging custom synthesises to fulfill unmet needs of the Healthcare industry. We offer the synthesis of a wide variety of organic compounds ranging from small organic molecules to larger ones from mg to kg.

We will be very pleased to prepare a proposal for the molecules to be synthesized. Refer to the questionaire below.

synthesis56

Clinical trials

We aim to be a leading Clinical Research Organization for the healthcare industry. We provide comprehensive BA / BE services, Bioanalytical services & Clinical Development for global clients in the pharmaceutical and biotech industries. Our technical expertise, sound service setup, and compliance with major regulations make us to commit deliverables on time, regardless of your project size.

clinicaltrial5

Our R&D experts strive to provide a high level of technical competence and customer service while maintaining strict adherence to confidentiality and ethical principles. We ensure that every study is conducted in accordance with GCP, GLP guidelines and other applicable regulatory requirements.

clinicaltrial8

For a speedy R&D offer preparation we need some information, as below:

Your email adress:   

Your member number: 

Product development

Generics name

Strength (mg)

Dosage form

Solids

  regular tablet

  Bi -layer tablet

  dispersable tablet

  chewable tablet

  orally desintegrating tablet

  effervescent tablet

  extended/sustained release tabl

  capsule (hard or soft)

 delayed release tablet

  pellets (IR / DR)

  pellets (ER / SR)

  MUPS tablet

Liquids

  eyedrops / solutions

  eardrops

  nasal drops / spray

  dry powder (souble)

 solution

  suspension

  syrup

  emulsion

Parenterals

  lyophilized

 injectable

Topical

  cream

 ointment

 gel

 lotion

Reference product name

Target file / submission date

Territories

AUSTR NZ  SAUDI ARABIA  RUSSIA  CANADA LATIN AMERIKA  USA  EU  ROW (rest of world)

API details

API to be used

API to be identified/procured by

Intellectual property

Patents to be screened & reports to be provided by

Reference drugs (RLD)

Product development

Analytical development (select multiple options with control key pressed)

Any other analytics required (specifiy)

Manufacturing requirement (select multiple options with control key pressed)

 No

 Yes

Stability requirement

 No

 Yes

Stability studies requirement

accelerated

intermediate

long-term

R&D bench scale

 

 

 

R&D lab scale

 

 

 

GMP / scale up

 

 

 

Stability studies at special conditions (specifiy)

Bioequivalence (BE) study requirement (select multiple options with control key pressed)

 No

 Yes

Dossier requirement (select multiple options with control key pressed)

 No

 Yes

Upload file 1

Upload file 2

Comments

After submit wait-your upload will be confirmed!