The Pharmaceutical Development Group has a submission to the US Food and Drug Administration (FDA) by the pharmaceutical central consultant. Also including approvals and post-marketing issues. We are experts in medicinal chemistry and formulation development services. Our motive is finding a rapid and cost-effective way to enhance your molecule from development to commercialization. PDG will create strategic plans and methods are designed to maximize the safety, efficacy and commercial value of your products in the market.
What is Pharmaceutical Consulting Services?
PDG has a team of pharmaceutical consulting professionals and experts who specialize in the development of drugs, labeling, Quality Assurance, compliance, and many other services. On the other hand, we have technical writing, citizen petitions, and legal support. PDG has worked on enormous projects with the FDA spans a variety of dosage forms and therapeutic areas.
Drug post-launch activities: After the post-launch, a new drug requires companies to robustly track, report and evaluate worldwide conflicting information. Safety data should be driven from the manufacturer’s internal studies, foreign adverse event records, ongoing U.S trials, patient data repositories, and some other databases. In the PDG, the post-marketing members will contain epidemiologists, clinician and regulatory experts will deliver evidence-based analyses to address the safety measures and ongoing benefits and risks of your drug product. Here some of the safe surveillance activities provided by the PDG are Safety Reports, Individual Case Reports, Literature Searches, Safety Signal Detection, Safety database, and Risk Management. Drug labeling gives you printed safety information that includes dietary supplement and warning-related messages.
Quality Analysis and Assurance: PDG has retain the pharmaceutical services to maintain contest with global good clinical practice, good laboratory, and manufacturing practice (GLP & GMP) and pharmacovigilance (PV) standards. It is positioned to address the pre- and post-approval preparedness concerns to your drug product, manufacturing facilities, and suppliers.
Why strategic drug development services needed?
The US pharmaceutical clients of PDG navigate the strategic drug development services that are analysis of commercial potential during the earlier stage of clinical development comparatively with regulatory planning. We discuss with clients then only move on with repurpose, reposition and reformulate drugs such as Orphan drugs, Fixed-Dose Combinations, Rx to OTC switches and other products. PDG’s aim is getting smarter and faster. We have a huge number of pharma clients via hundreds of pharmaceutical product development projects. Our strength is formulation driven and use of traditional oral dosage forms. In complex dosages, such as inhalers, parenteral, and transdermal systems. Have a wide range of experience across disease states indicating therapies at neurology, endocrine, cardiovascular, pulmonary, oncology, analgesic, and anti-infective indications.
Do you know the specialty services at PDG?
Preparation of the materials required for a clinical study. Some of the events like product licensing opportunities of FDA regulations need a demand to take immediate attention and expertise. PDG provides a variety of consulting competencies and capacity of giving special services that will help you to address your challenges. Litigation support includes both civil and criminal cases on the state and federal level also. Such as product liability, failure to warn, product failure, Lanham act, securities, and action-related cases. PDG’s expertise is not limited to document review and summarization, analysis of safety database, deposition testimony, preparation of chronologies and trial testimony. Preparation of active drug products and analytical tests of active substances
Why we use combination pharmaceutical development?
PDG has experience in the development of combination products and combination drugs therapies such as drug/devices, biologics/device or drug/device/biologics are regulated with a single unit. The proposed investigational plans to FDA reviewed by non-clinical and clinical data generated with the relevant device. We are experienced all IND and NDA requirements including:
- Toxicology
- Strategy development labeling
- Clinical safety
- Published clinical literature
- Clinical efficacy and Nonprescription products
Effective OTC Drug development in a legal manner: The main purpose of OTC drugs is simple and less harmful. We are developing the drugs in correct composition and use the appropriate chemical formula. This will helps us to cure diseases. The FDA will define the safety measure, labeling, and effectiveness of the OTC active ingredients. That will help the consumers used securely, even completely safe for health if it is used by the kids and it will not harm their health. For instance, the drugs are necessary for the animals and we must follow the procedures and precautions. The Nonprescription OTC drug development will protect people from risk and these kinds of drugs are helpful to all aged people and never cause any side effects and health issues. It offers many services as your long-term regulatory partner throughout the lifespans of your product or drug. Maintains readiness to address any challenges and capacity that will take immediate response by the consultants. PDG has a professional staff that is on-call for the client 24/7.
