serving the pharmaceutical & related industries

Pharmaceutical Consulting

Development

Pharmaceutical Development

INDs (Investigational New Drug) & ANDs (Abbreviated New Drugs)

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Application

Pharmaceutical Application Processing

Filing and Managing all of the Processes for FDA Drug Applications

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Compliance

Pharmaceutical Compliance

FDA and Global Regulatory Compliance and Submission

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Manufacturing

Pharmaceutical Manufacturing

Complete Facilities Design from inception to full FDA qualification

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Formulation and Product Development

 PTS Consulting Global Services has the expertise to direct all aspects of in-house formulation and product development licensing activities.

Formulation and Product DevelopmentWe have a full-fledged state-of-the-art Research & Development laboratory with all processing and testing equipment and operations.

 PTS Global Services has the experience to develop and review formulations with respect to patent infringement and compliance with FDA inactive ingredient lists.


Expertise in developing formulations in the following categories

  • Solid dosage form, e.g. tablets, capsules, powders, for immediate or modified release
  • Liquid Orals such as true solutions, suspensions, syrups, drops, etc, in fields such as antihistamines and other allergy related products, analgesics, antacids, laxatives, vitamins and supplements and other oral products for adult and children dosing regimens.
  • Suppositories and other specialized dosage forms.
  • Sterile ophthalmic solutions and other parenteral dosage forms
  • Inhalation powders, creams, gels, ointments and related compounds
  • Based on client request or needs, can design and develop most formulations at a fast pace.
  • Experienced in generic (immediate release, modified release, locally acting, parenterals), and INDs, NDA (including 505(b)(2)), BLAs, CTAs, DMFs.
  • Provide Regulatory input to R&D team in terms of product development including for products where FDA may not have requirements published.

Partnerships

NeuheitNeuheit Pharma Technologies Private Ltd is a Hyderabad based Research & Development Company specialized in the development of drug products.
The company is engaged in the development of complex generic and differentiated products from ideation to commercialization. It also offers consultancy services in all disciplines of pharmaceutical product development including Biostudies.

Contact PTS Global Services