Analytical Method Development and Validation Before the analysis of leachables samples, a test method must be developed and validated to ensure that the analytes of interest are not obscured or affected by the formulation of the drug product. Appropriate analytes of interest for testing are to be dertermined. Drawing from resources available in literature, or performing extractables profiles in chemistry laboratory, specific analytes of interest for a drug product are determined. Methods are developed for these analytes in the presence of drug product, ensuring that any samples preparation procedures are incorporated into these methods. Following development, the method is then validated per ICH guidelines. Various studies involved in validation services include: linearity testing, precision (repeatability and intermediate precision testing), accuracy, specificity, limit of detection, limit of quantification, range, robustness and stability of test solutions. Different techniques with a multitude of drug product solutions are Gas chromatography (GC), Gas chromatography/mass spectroscopy (GC/MS), High-performance liquid chromatography (HPLC), High-performance liquid chromatography/mass spectroscopy (HPLC/MS), Inductively coupled plasma (ICP) spectroscopy, Ultraviolet/visible (UV/VIS) spectroscopy etc. New Sterilization Process Development and Characterization Solutions for FDA’s requirements for the testing required for a 510(k) submission for a new sterilization process can be provided by the laboratories. Biological and chemical indicators development, perform testing to prove that the sterilizer and sterilized materials are safe, and investigate the toxicity of any residuals. Laboratories GMP labs perform method development and validation for a broad spectrum of biopharmaceuticals and dosage forms across all phases of pharmaceutical development. Apart from method development, experimental design, method validation protocol development, gap analyses, remedial method validation and customized method validation reports may also be provided. Method development and validation for chromatography techniques including HPLC, UPLC, GC, SEC and IC with a variety of detection technologies including UV, DAD, FL, MS, ELSD, RI, PAD, FID, TCD, MALS, CAD Method development and validation for stability-indicating assays and related substances methods for drug substance and drug products, such as, tablets, capsules, suspensions, creams, injectables, nasal sprays, pMDIs, DPIs, medicated feeds, drug-eluting stents Method development, validation and quality control services for: Dissolution (IR, ER, MR), Organic volatile impurities, Preservatives and antioxidants, Clinical comparator assay and dissolution. Analytical support for process and cleaning validation on various surfaces by HPLC, UPLC, TOC and GC, Dose verification for GLP studies, Bioequivalency, in vitro pharmaceutical equivalency testing. Quality control support for Dosing solution analysis for toxicology studies, Customer product complaint testing, Field monitoring testing, Generation of statistical quality control charts.

- Service Details

Methods transfers are performed according to the GMP procedures and approved method transfer protocols. Similarly, method validations are also strictly performed according to the GMP procedures and approved validation protocols.

- Service Details

Product development is closely supported by a highly experienced analytical development & expertise team during every phase of the development process, and we strive to proactively manage the issues that might arise and resolve them.

- Service Details

Through ChemWerth’s own laboratory, we can provide analytical services from methods development to methods validation.

- Service Details

We have a dedicated analytical development laboratory to support the synthesis group. Our major activities - Analytical method development & validation, for RM, WIP & Finished Products, OVI method development & Method validation, Impurity profile studies

- Service Details

We provide full analytical support including Analytical Method Transfer, Analytical Method Validation in accordance with ICH guidelines, Quality control & Release testing of raw materials & FDFs, Stability studies in different ICH storage conditions, etc

- Service Details

AMRI's laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer — covering procedures for APIS, formulations, cosmetics, and raw materials etc.

- Service Details

Bachem constantly develops and validates new analytical methods, aiming at setting industrial standards in the analysis of peptides.

- Service Details

With our vast experience we add exponential value to our client’s R&D programs at every stage of the drug development. We serve as a vital link between the pharmaceutical companies and the healthcare industry.

- Service Details

Malladi’s Research & Development is well-equipped with a wide range of process & analytical capabilities such as method development & specification development for raw material/API, method validation, impurity identification and stability studies.

- Service Details

Temad offers various analytical services such as Method of Analysis Development & Validation, Identification, Separation, Physical & Chemical characterization of impurities based on the latest pharmacopeias, Issuance of impurity profile etc.

- Service Details

We support your API development & manufacturing requirements. Our CDMO Services include technology transfer, process development, analytical methods development, synthesis of impurities & standards, potential genotoxic impurities evaluation etc

- Service Details

We provide the study and validation of methods of analysis for the control of the active ingredient and its impurities, in both the raw material and the finished product.

- Service Details

Our contract services group helps companies turn their new drug ideas into reality. Whether for phase I, phase II, phase III, or toxicology studies, we specialize in developing new synthetic routes while providing all necessary support to ensure regulatory compliance.

- Service Details

Recro provides various analytical testing services including raw material, in-process & finished product release testing, physiochemical characterization, method development & validation (assay, impurities, dissolution, cleaning), residual solvents by GC.

- Service Details

ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development & validation, & stability testing. All analytical instruments & data are managed through the company's LIMS.

- Service Details

Unither analytical services include methods development & validation, analytical methods transfer, ICH stability studies with storage, extractable & leachable closure system compatibility studies, unknown substance identification & characterization etc .

- Service Details

Uquifa offers the opportunity to manage the development activities of any drug life cycle by offering services on DMF/CTD/COS application, stability studies, process validation and analytical method validation, working standard supply or impurity

- Service Details

Dishman's analytical services support both process control and material characterization including method development & validation for laboratory and production chemistry from initial raw material release to release of the final APIs.

- Service Details

Analytical development (UV/CAD/RID-HPLC, GC, HS-GC), structural characterization (GC-MS, HPLC- MS, NMR, IR)

- Service Details

Our Pre-clinical & Phases I & II services include pre-formulation, formulation development, analytical method development & evaluation, cleaning residure test, CTM lots testing, analytical method development & validation etc.