Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory



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Doctors and Scientists

PharmaDirections’ Clients

A sampling from the over 100 clients that we have helped with their drug development.

  Directed peptide product formulation development.
  Implemented business development initiatives for novel vaccine asset.
  Directed complete IND program to develop a product for vascular depression.
  Conducted due diligence and audit of potential contract manufacturing investment.
  Developed new intellectual property strategies for repurposed drugs.
Conducted PK modeling and analysis.
  Reformulated oral product to increase bioavailability.
 
 Helped with development of biologic drugs.
 

Provided pharmacokinetic modeling and general consulting services.
  Prepared strategic plans for IND enabling program.
Overseeing preparation of IND and CTM manufacturing.
  Conducted gap analysis on lead program.
  Conducted due diligence on a novel adjunct to cancer therapy.
Designed preclinical research program.
  Managing product development of a biologic.
  Developing formulation for combination product for use in Phase 1 and 2 clinical trials.
  Assisted with preparation of CMC section of a biologics BLA.
  Provided PK modeling and supported development of QD formulation.
Conducted Cost of Goods Analysis for API at full commercial scale.
Helped prepare CMC section of NDA.
  Conducted drug discovery and development gap analysis..
Provided out-licensing due diligence consulting services.
 


 Conducted due diligence for a potential cancer company investment.
 
 Prepared a guide for peptide drug development.
Customized stability trending software to accept Sponsor's data.
Helped develop new product R&D strategies.
  Conducted due diligence on a novel drug platform.
  Conducted preclinical and CMC due diligence on several potential portfolio companies.
  Multiple projects.
  Developed new intellectual property using PK modeling and unique drug delivery system.
Prepared and filed pre-IND Briefing Book and Initial IND.
Manufactured clinical trial materials for orphan drug trial.
  Wrote strategic plan to support the clinical development, regulatory and logistic aspects of an ENT product.
 
 Provided guidance on alternative formulations for a proprietary OTC product.
 

Directed complete IND and Phase 1 program.
Guided development of novel synthetic process.
Manufactured clinical trial materials.
 

Manufactured GMP batches for clinical trials in US and Europe.
Managed packaging and distribution of clinical trial materials.
Developed biomarker assay and commercialization plan.

Conducted due diligence on a drug company with a unique gastric delivery device.
Conducted due diligence on a biologic for topical use.

  Directed research of a highly potent compound in Chinese research lab.
Selected contract manufacturer and oversaw production of sterile clinical trial materials.
 

Argolyn
Wrote and helped direct strategic development plan.
Selected toxicology labs and monitored toxicology data.
 

ImaRx
Managed the program to install, qualify and operate a proprietary manufacturing machine invented by the sponsor.
Provided detailed assessments of facilities, equipment and processes required for asceptic manufacturing using the proprietary equipment.
 

MGI Pharma, Inc. (Acquired by Eisai)
Assisted in changing packaging for GBM product.
Wrote regulatory strategy and plan.
Helped write CMC section of NDA.
 

Nuada Pharmaceuticals
Wrote IND enabling project plan included details on activity, timeline, estimated cost and overall burn rate.
 

Nitrox, LLC
Determined most suitable data management system for their development needs.
Helped resolve formulation challenges.
Designed quality system and wrote corporate SOPs.
 

Osprey Pharmaceutics
Assisted in developing biological potency assay.
 

Panacos Pharmaceuticals, Inc.
Assisted with API process development and manufacturing.

Protez Pharmaceuticals (Acquired by Novartis)

Generated a product development plan.
Managed CMC activities especially formulation development.

 

SurfaceLogix, Inc. (Acquired by Nano Terra)

 Helped with scale up of existing synthesis to kilo scale and found significant cost savings.
Conducted toxicokinetic evaluations.

Synagile Corporation

Provided formulation development and manufacturing support.