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Track 16: Pharmacy Development Services

What is Pharmaceutical Development

The pharmaceutical, biopharmaceutical, medical device, and cosmetic sectors are served by Pharmaceutical Development Services (PDS), a pharmaceutical and regulatory consulting firm. We offer professional guidance on drug research and production strategy, covering the creation, supply, and governmental oversight of fresh and seasoned pharmaceutical goods.

PDS has a sizable network of consultants who, when called upon for a specific project, may offer in-depth and current expert technical expertise. Additionally, PDS consultants serve as skilled temporary managers for top positions in quality control, pharmaceutical development, and regulatory affairs.

Issues with CRO management and CRO selection

PDS consultants help businesses from the preclinical stage through phase three by helping them place work with CROs. According to their qualifications, CROs are chosen for certain projects in this process. They also offer guidance on CRO management difficulties and how to prevent technical work outsourcing errors.

Agreement QP service

PDS's knowledgeable consultants provide audits of manufacturing plants, laboratories, and contractors for customers. Each consultant has extensive knowledge and expertise in their respective technological fields. GMP, GDP, and GCP audits can be conducted in accordance with these standards. PDS can offer guidance on quality assurance tactics as well as help with pre-approval and other regulatory inspection preparation. PDS provides a contract QP service, and its employees are qualified for nomination as QPs under the permanent provisions of Directives 2001/83/EC and 2001/20/EC. They are also qualified to release both commercially available medicines and experimental ones.

Medical equipment

Medical device makers receive assistance from PDS in both technical and regulatory areas. PDS can provide clients with guidance on a wide range of medical device challenges, from pre-CE marking help and device classification through to vigilance support.

PDS may help with the creation and upkeep of technical files, offer guidance on labelling, compliance, claims, and instructions, and set up translations. The knowledgeable staff at PDS may also create and submit documents for clinical research or studies. PDS will represent clients' interests in vigilance situations by advising, assisting, and submitting adverse incident reports to the necessary competent authorities. PDS can serve as the authorised representative for device manufacturers outside of the EU, keeping a close eye on all issues that impact the customer, including any necessary regulatory revisions.

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Introducing products

PDS offers businesses strategic advice on how to launch innovative products, from pre-clinical technical development through a global commercial launch. Project management, due diligence, a launch strategy, a production strategy, a technology transfer strategy, and regulatory concerns are involved. This guarantees that a new product is introduced that satisfies all requirements and is adequately marketed with the appropriate amount of product in the appropriate place at the appropriate time.

Legislative issues

PDS offers strategic regulatory guidance and assistance for agency submissions, due diligence, writing regulatory dossiers, and dealing with regulatory bodies' comments once the dossier has been submitted. PDS has experience in small molecules, biotechnology compounds, herbal medicines, nutraceuticals, cosmetics, and medical equipment.

Pharmacological instruction

Through its sibling company PharmaTraining Services, PDS offers professional in-house and public training courses. For information about their current training services, see the website.